Your browser doesn't support javascript.
Шоу: 20 | 50 | 100
Результаты 1 - 20 de 31
Фильтр
Добавить фильтры

база данных
Годовой диапазон
1.
World Neurosurg ; 157: e357-e363, 2022 01.
Статья в английский | MEDLINE | ID: covidwho-1757929

Реферат

BACKGROUND: Prior studies demonstrated reduced risk for venous thromboembolism (VTE) in neurosurgical patients secondary to prophylaxis with both heparin and low-molecular-weight heparin. The ability to monitor low-molecular-weight heparin by obtaining anti-factor Xa (anti-Xa) serum levels provides an opportunity to evaluate safety and efficacy. The aim of this study was to describe characteristics of patients who have anti-Xa levels outside of the goal range (0.2-0.4/0.5 IU/mL) and investigate incidence of major bleeding and VTE. METHODS: A single-center, retrospective, observational study was conducted on neurosurgical patients receiving enoxaparin for VTE prophylaxis between August 2019 and December 2020. Significance testing was conducted via Fisher exact test and independent samples t test. RESULTS: The study included 85 patients. Patients were less likely to have an anti-Xa level in the goal range if they were male, had a higher weight, or were morbidly obese. Three neuroendovascular patients (3.5%) experienced a major bleed. Serum anti-Xa levels were significantly higher in patients who experienced major bleeds compared with patients who did not (0.45 ± 0.16 IU/mL vs. 0.28 ± 0.09 IU/mL, P = 0.003). Patients with a supraprophylactic anti-Xa level (>0.5 IU/mL) were more likely to experience a major bleed (P = 0.005). One VTE event occurred: the patient experienced a pulmonary embolism with anti-Xa level at goal. CONCLUSIONS: Anti-Xa-guided enoxaparin dosing for VTE prophylaxis in neurosurgical patients may help prevent major bleeding. These data suggest that a higher anti-Xa level may predispose patients to major bleeding. Further evaluation is needed to identify the goal anti-Xa level for VTE prophylaxis in this population.


Тема - темы
Enoxaparin/blood , Factor Xa Inhibitors/blood , Hemorrhage/blood , Neurosurgical Procedures/trends , Pre-Exposure Prophylaxis/trends , Adult , Aged , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Anticoagulants/blood , Drug Monitoring/methods , Enoxaparin/administration & dosage , Enoxaparin/adverse effects , Factor Xa Inhibitors/administration & dosage , Factor Xa Inhibitors/adverse effects , Female , Hemorrhage/prevention & control , Humans , Male , Middle Aged , Obesity, Morbid/blood , Obesity, Morbid/surgery , Pre-Exposure Prophylaxis/methods , Retrospective Studies , Sex Factors , Venous Thromboembolism/blood , Venous Thromboembolism/prevention & control
2.
Am J Trop Med Hyg ; 105(6): 1472-1475, 2021 Oct 04.
Статья в английский | MEDLINE | ID: covidwho-1629955

Реферат

Human lives and nations' economies have been adversely affected worldwide by the COVID-19 pandemic. The hyperinflammatory state associated with the disease may be related to mortality. Systemic glucocorticoid is the first-line therapy for cytokine storm. Various immunomodulatory drugs such as tocilizumab and baricitinib have been used in those not responding to glucocorticoid monotherapy. Amid the peak crisis of COVID-19 in India, there was an extreme paucity of medications, oxygen, and hospital beds. We describe three patients with COVID-19 who received low-dose tofacitinib (an oral Janus kinase inhibitor) in addition to moderate-dose glucocorticoid. These patients were treated at their homes, as the hospitals were short of beds. Rapid reduction in hypoxemia along with gradual resolution of other signs of the disease were observed. The results are reassuring regarding the feasibility of managing of severe COVID-19 outside the hospital setting when healthcare resources are overwhelmed by pandemic-related caseload.


Тема - темы
COVID-19/drug therapy , Piperidines/therapeutic use , Pyrimidines/therapeutic use , SARS-CoV-2 , Adult , Aged , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Anti-Inflammatory Agents/therapeutic use , Cytokine Release Syndrome/prevention & control , Cytokines/genetics , Cytokines/metabolism , Enoxaparin/administration & dosage , Enoxaparin/therapeutic use , Female , Gene Expression Regulation/drug effects , Humans , Methylprednisolone/administration & dosage , Methylprednisolone/therapeutic use , Middle Aged , Piperidines/administration & dosage , Prednisone/administration & dosage , Prednisone/therapeutic use , Pyrimidines/administration & dosage
3.
Inflamm Res ; 71(1): 39-56, 2022 Jan.
Статья в английский | MEDLINE | ID: covidwho-1525531

Реферат

The COVID-19 pandemic created a worldwide debilitating health crisis with the entire humanity suffering from the deleterious effects associated with the high infectivity and mortality rates. While significant evidence is currently available online and targets various aspects of the disease, both inflammatory and noninflammatory kidney manifestations secondary to COVID-19 infection are still largely underrepresented. In this review, we summarized current knowledge about COVID-19-related kidney manifestations, their pathologic mechanisms as well as various pharmacotherapies used to treat patients with COVID-19. We also shed light on the effect of these medications on kidney functions that can further enhance renal damage secondary to the illness.


Тема - темы
COVID-19/drug therapy , COVID-19/physiopathology , Kidney Diseases/physiopathology , Kidney/injuries , Acute Kidney Injury/complications , Aldosterone/metabolism , Angiotensins/chemistry , Antibodies, Monoclonal, Humanized/administration & dosage , Autopsy , Biopsy , COVID-19/complications , COVID-19 Vaccines , Dexamethasone/administration & dosage , Enoxaparin/administration & dosage , Heparin/administration & dosage , Heparin, Low-Molecular-Weight/administration & dosage , Humans , Inflammation , Interleukin 1 Receptor Antagonist Protein/administration & dosage , Kidney Diseases/complications , Kidney Transplantation , Lopinavir/administration & dosage , Pandemics , Renal Replacement Therapy , Renin-Angiotensin System , Ritonavir/administration & dosage , SARS-CoV-2
4.
JAMA Intern Med ; 181(12): 1612-1620, 2021 12 01.
Статья в английский | MEDLINE | ID: covidwho-1453495

Реферат

Importance: Hospitalized patients with COVID-19 are at risk for venous and arterial thromboembolism and death. Optimal thromboprophylaxis dosing in high-risk patients is unknown. Objective: To evaluate the effects of therapeutic-dose low-molecular-weight heparin (LMWH) vs institutional standard prophylactic or intermediate-dose heparins for thromboprophylaxis in high-risk hospitalized patients with COVID-19. Design, Setting, and Participants: The HEP-COVID multicenter randomized clinical trial recruited hospitalized adult patients with COVID-19 with D-dimer levels more than 4 times the upper limit of normal or sepsis-induced coagulopathy score of 4 or greater from May 8, 2020, through May 14, 2021, at 12 academic centers in the US. Interventions: Patients were randomized to institutional standard prophylactic or intermediate-dose LMWH or unfractionated heparin vs therapeutic-dose enoxaparin, 1 mg/kg subcutaneous, twice daily if creatinine clearance was 30 mL/min/1.73 m2 or greater (0.5 mg/kg twice daily if creatinine clearance was 15-29 mL/min/1.73 m2) throughout hospitalization. Patients were stratified at the time of randomization based on intensive care unit (ICU) or non-ICU status. Main Outcomes and Measures: The primary efficacy outcome was venous thromboembolism (VTE), arterial thromboembolism (ATE), or death from any cause, and the principal safety outcome was major bleeding at 30 ± 2 days. Data were collected and adjudicated locally by blinded investigators via imaging, laboratory, and health record data. Results: Of 257 patients randomized, 253 were included in the analysis (mean [SD] age, 66.7 [14.0] years; men, 136 [53.8%]; women, 117 [46.2%]); 249 patients (98.4%) met inclusion criteria based on D-dimer elevation and 83 patients (32.8%) were stratified as ICU-level care. There were 124 patients (49%) in the standard-dose vs 129 patients (51%) in the therapeutic-dose group. The primary efficacy outcome was met in 52 of 124 patients (41.9%) (28.2% VTE, 3.2% ATE, 25.0% death) with standard-dose heparins vs 37 of 129 patients (28.7%) (11.7% VTE, 3.2% ATE, 19.4% death) with therapeutic-dose LMWH (relative risk [RR], 0.68; 95% CI, 0.49-0.96; P = .03), including a reduction in thromboembolism (29.0% vs 10.9%; RR, 0.37; 95% CI, 0.21-0.66; P < .001). The incidence of major bleeding was 1.6% with standard-dose vs 4.7% with therapeutic-dose heparins (RR, 2.88; 95% CI, 0.59-14.02; P = .17). The primary efficacy outcome was reduced in non-ICU patients (36.1% vs 16.7%; RR, 0.46; 95% CI, 0.27-0.81; P = .004) but not ICU patients (55.3% vs 51.1%; RR, 0.92; 95% CI, 0.62-1.39; P = .71). Conclusions and Relevance: In this randomized clinical trial, therapeutic-dose LMWH reduced major thromboembolism and death compared with institutional standard heparin thromboprophylaxis among inpatients with COVID-19 with very elevated D-dimer levels. The treatment effect was not seen in ICU patients. Trial Registration: ClinicalTrials.gov Identifier: NCT04401293.


Тема - темы
Anticoagulants/administration & dosage , COVID-19/diagnosis , Enoxaparin/administration & dosage , Heparin, Low-Molecular-Weight/administration & dosage , Heparin/administration & dosage , Hospital Mortality , Inpatients , Venous Thromboembolism/prevention & control , Adult , Aged , COVID-19/blood , COVID-19/therapy , Female , Fibrin Fibrinogen Degradation Products/analysis , Hospitalization , Humans , Intensive Care Units , Male , SARS-CoV-2 , Treatment Outcome
5.
Platelets ; 33(3): 471-478, 2022 Apr 03.
Статья в английский | MEDLINE | ID: covidwho-1366890

Реферат

We analyze changes in circulating platelets in COVID-19 positive patients who received conventional treatment Dexamethasone and Enoxaparin (Dexa-Enoxa) compared to patients treated with conventional therapy plus nebulization with alkaline hypertonic ibuprofenate (AHI). Results show that after 24 h of nebulization with AHI, circulating platelets shows an increase about 40% at 24 h and reach 65% at 96 h. In patients with platelets content below 200,000 by microliter the increase was 49% and 79% at 24 and 96 h respectively. In patients with platelets above 200,000 by microliter the increase was 24% and 31% at 24 and 96 h, respectively. The increase of platelets via AHI was similar in both, men and women.To evaluate whether this action of AHI was related to platelets from COVID-19 positive patients or also for healthy people, two controls were included: one of them with 10 healthy volunteers and another one with COVID-19 positive patients hospitalized and treated only with Dexa-Enoxa. Results show that, in healthy volunteers, the number of circulating platelets remains unchanged even after 7 days of treatment with AHI. In COVID-19 positive patients treated only with Dexa-Enoxa for 4 days, platelets increased only 16%.


Тема - темы
Blood Platelets/metabolism , COVID-19 , Enoxaparin/administration & dosage , Ibuprofen/administration & dosage , SARS-CoV-2/metabolism , Adult , COVID-19/blood , COVID-19/drug therapy , Female , Humans , Male , Middle Aged , Nebulizers and Vaporizers , Platelet Count
6.
Am Heart J ; 238: 1-11, 2021 08.
Статья в английский | MEDLINE | ID: covidwho-1309127

Реферат

BACKGROUND: Observational studies have suggested a higher risk of thrombotic events in patients with coronavirus disease 2019 (COVID-19). Moreover, elevated D-dimer levels have been identified as an important prognostic marker in COVID-19 directly associated with disease severity and progression. Prophylactic anticoagulation for hospitalized COVID-19 patients might not be enough to prevent thrombotic events; therefore, therapeutic anticoagulation regimens deserve clinical investigation. DESIGN: ACTION is an academic-led, pragmatic, multicenter, open-label, randomized, phase IV clinical trial that aims to enroll around 600 patients at 40 sites participating in the Coalition COVID-19 Brazil initiative. Eligible patients with a confirmed diagnosis of COVID-19 with symptoms up to 14 days and elevated D-dimer levels will be randomized to a strategy of full-dose anticoagulation for 30 days with rivaroxaban 20 mg once daily (or full-dose heparin if oral administration is not feasible) vs standard of care with any approved venous thromboembolism prophylaxis regimen during hospitalization. A confirmation of COVID-19 was mandatory for study entry, based on specific tests used in clinical practice (RT-PCR, antigen test, IgM test) collected before randomization, regardless of in the outpatient setting or not. Randomization will be stratified by clinical stability at presentation. The primary outcome is a hierarchical analysis of mortality, length of hospital stay, or duration of oxygen therapy at the end of 30 days. Secondary outcomes include the World Health Organization's 8-point ordinal scale at 30 days and the following efficacy outcomes: incidence of venous thromboembolism , acute myocardial infarction, stroke, systemic embolism, major adverse limb events, duration of oxygen therapy, disease progression, and biomarkers. The primary safety outcomes are major or clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria. SUMMARY: The ACTION trial will evaluate whether in-hospital therapeutic anticoagulation with rivaroxaban for stable patients, or enoxaparin for unstable patients, followed by rivaroxaban through 30 days compared with standard prophylactic anticoagulation improves clinical outcomes in hospitalized patients with COVID-19 and elevated D-dimer levels.


Тема - темы
Anticoagulants/therapeutic use , COVID-19/complications , Enoxaparin/therapeutic use , Rivaroxaban/therapeutic use , Thrombosis/prevention & control , Administration, Oral , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Brazil , COVID-19/blood , COVID-19/mortality , Drug Administration Schedule , Enoxaparin/administration & dosage , Enoxaparin/adverse effects , Fibrin Fibrinogen Degradation Products/analysis , Hemorrhage/chemically induced , Hospitalization , Humans , Oxygen Inhalation Therapy , Rivaroxaban/administration & dosage , Rivaroxaban/adverse effects , Thrombosis/etiology , Time Factors
7.
Thromb Haemost ; 122(1): 131-141, 2022 01.
Статья в английский | MEDLINE | ID: covidwho-1258614

Реферат

BACKGROUND: Thrombotic complications are considered among the main extrapulmonary manifestations of coronavirus disease 2019 (COVID-19). The optimal type and duration of prophylactic antithrombotic therapy in these patients remain unknown. METHODS: This article reports the final (90-day) results of the Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) study. Patients with COVID-19 admitted to intensive care were randomized to intermediate-dose versus standard-dose prophylactic anticoagulation for 30 days, irrespective of hospital discharge status. The primary efficacy outcome was a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause death. The main safety outcome was major bleeding. RESULTS: Of 600 randomized patients, 562 entered the modified intention-to-treat analysis (median age [Q1, Q3]: 62 [50, 71] years; 237 [42.2%] women), of whom 336 (59.8%) survived to hospital discharge. The primary outcome occurred in 132 (47.8%) of patients assigned to intermediate dose and 130 (45.4%) patients assigned to standard-dose prophylactic anticoagulation (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.95-1.55, p = 0.11). Findings were similar for other efficacy outcomes, and in the landmark analysis from days 31 to 90 (HR: 1.59, 95% CI: 0.45-5.06). There were 7 (2.5%) major bleeding events in the intermediate-dose group (including 3 fatal events) and 4 (1.4%) major bleeding events in the standard-dose group (none fatal) (HR: 1.82, 95% CI: 0.53-6.24). CONCLUSION: Intermediate-dose compared with standard-dose prophylactic anticoagulation did not reduce a composite of death, treatment with ECMO, or venous or arterial thrombosis at 90-day follow-up.


Тема - темы
Anticoagulants/administration & dosage , COVID-19/drug therapy , Enoxaparin/administration & dosage , SARS-CoV-2 , Thrombosis/prevention & control , Aged , Anticoagulants/adverse effects , COVID-19/complications , COVID-19/mortality , Cohort Studies , Critical Care , Dose-Response Relationship, Drug , Enoxaparin/adverse effects , Extracorporeal Membrane Oxygenation , Female , Hemorrhage/chemically induced , Humans , Intensive Care Units , Iran/epidemiology , Kaplan-Meier Estimate , Male , Middle Aged , Pandemics , Thrombosis/etiology , Thrombosis/mortality
8.
JAMA ; 325(16): 1620-1630, 2021 04 27.
Статья в английский | MEDLINE | ID: covidwho-1239957

Реферат

Importance: Thrombotic events are commonly reported in critically ill patients with COVID-19. Limited data exist to guide the intensity of antithrombotic prophylaxis. Objective: To evaluate the effects of intermediate-dose vs standard-dose prophylactic anticoagulation among patients with COVID-19 admitted to the intensive care unit (ICU). Design, Setting, and Participants: Multicenter randomized trial with a 2 × 2 factorial design performed in 10 academic centers in Iran comparing intermediate-dose vs standard-dose prophylactic anticoagulation (first hypothesis) and statin therapy vs matching placebo (second hypothesis; not reported in this article) among adult patients admitted to the ICU with COVID-19. Patients were recruited between July 29, 2020, and November 19, 2020. The final follow-up date for the 30-day primary outcome was December 19, 2020. Interventions: Intermediate-dose (enoxaparin, 1 mg/kg daily) (n = 276) vs standard prophylactic anticoagulation (enoxaparin, 40 mg daily) (n = 286), with modification according to body weight and creatinine clearance. The assigned treatments were planned to be continued until completion of 30-day follow-up. Main Outcomes and Measures: The primary efficacy outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days, assessed in randomized patients who met the eligibility criteria and received at least 1 dose of the assigned treatment. Prespecified safety outcomes included major bleeding according to the Bleeding Academic Research Consortium (type 3 or 5 definition), powered for noninferiority (a noninferiority margin of 1.8 based on odds ratio), and severe thrombocytopenia (platelet count <20 ×103/µL). All outcomes were blindly adjudicated. Results: Among 600 randomized patients, 562 (93.7%) were included in the primary analysis (median [interquartile range] age, 62 [50-71] years; 237 [42.2%] women). The primary efficacy outcome occurred in 126 patients (45.7%) in the intermediate-dose group and 126 patients (44.1%) in the standard-dose prophylaxis group (absolute risk difference, 1.5% [95% CI, -6.6% to 9.8%]; odds ratio, 1.06 [95% CI, 0.76-1.48]; P = .70). Major bleeding occurred in 7 patients (2.5%) in the intermediate-dose group and 4 patients (1.4%) in the standard-dose prophylaxis group (risk difference, 1.1% [1-sided 97.5% CI, -∞ to 3.4%]; odds ratio, 1.83 [1-sided 97.5% CI, 0.00-5.93]), not meeting the noninferiority criteria (P for noninferiority >.99). Severe thrombocytopenia occurred only in patients assigned to the intermediate-dose group (6 vs 0 patients; risk difference, 2.2% [95% CI, 0.4%-3.8%]; P = .01). Conclusions and Relevance: Among patients admitted to the ICU with COVID-19, intermediate-dose prophylactic anticoagulation, compared with standard-dose prophylactic anticoagulation, did not result in a significant difference in the primary outcome of a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days. These results do not support the routine empirical use of intermediate-dose prophylactic anticoagulation in unselected patients admitted to the ICU with COVID-19. Trial Registration: ClinicalTrials.gov Identifier: NCT04486508.


Тема - темы
Anticoagulants/administration & dosage , COVID-19/complications , Enoxaparin/administration & dosage , Extracorporeal Membrane Oxygenation , Oxygen Inhalation Therapy/methods , Thrombosis/prevention & control , Aged , Anticoagulants/adverse effects , COVID-19/mortality , Drug Administration Schedule , Enoxaparin/adverse effects , Female , Hemorrhage/chemically induced , Hospitalization , Humans , Intensive Care Units , Iran , Length of Stay/statistics & numerical data , Male , Middle Aged , Odds Ratio , Outcome Assessment, Health Care , Pulmonary Embolism/epidemiology , Thrombocytopenia/chemically induced , Thrombosis/etiology , Thrombosis/mortality , Treatment Outcome , Venous Thrombosis/epidemiology , Venous Thrombosis/mortality
9.
Plast Reconstr Surg ; 147(4): 947-958, 2021 04 01.
Статья в английский | MEDLINE | ID: covidwho-1174990

Реферат

BACKGROUND: The accepted "one-size-fits-all" dose strategy for prophylactic enoxaparin may not optimize the medication's risks and benefits after surgical procedures. The authors hypothesized that weight-based administration might improve the pharmacokinetics of prophylactic enoxaparin when compared to fixed-dose administration. METHODS: The FIxed or Variable Enoxaparin (FIVE) trial was a randomized, double-blind trial that compared the pharmacokinetic and clinical outcomes of patients assigned randomly to postoperative venous thromboembolism prophylaxis using enoxaparin 40 mg twice daily or enoxaparin 0.5 mg/kg twice daily. Patients were randomized after surgery and received the first enoxaparin dose at 8 hours after surgery. Primary hypotheses were (1) weight-based administration is noninferior to a fixed dose for avoiding underanticoagulation (anti-factor Xa <0.2 IU/ml) and (2) weight-based administration is superior to fixed-dose administration for avoiding overanticoagulation (anti-factor Xa >0.4 IU/ml). Secondary endpoints were 90-day venous thromboembolism and bleeding. RESULTS: In total, 295 patients were randomized, with 151 assigned to fixed-dose and 144 to weight-based administration of enoxaparin. For avoidance of under anticoagulation, weight-based administration had a greater effectiveness (79.9 percent versus 76.6 percent); the 3.3 percent (95 percent CI, -7.5 to 12.5 percent) greater effectiveness achieved statistically significant noninferiority relative to the a priori specified -12 percent noninferiority margin (p = 0.004). For avoidance of overanticoagulation, weight-based enoxaparin administration was superior to fixed-dose administration (90.6 percent versus 82.2 percent); the 8.4 percent (95 percent CI, 0.1 to 16.6 percent) greater effectiveness showed significant safety superiority (p = 0.046). Ninety-day venous thromboembolism and major bleeding were not different between fixed-dose and weight-based cohorts (0.66 percent versus 0.69 percent, p = 0.98; 3.3 percent versus 4.2 percent, p = 0.72, respectively). CONCLUSION: Weight-based administration showed superior pharmacokinetics for avoidance of underanticoagulation and overanticoagulation in postoperative patients receiving prophylactic enoxaparin. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.


Тема - темы
Anticoagulants/administration & dosage , Enoxaparin/administration & dosage , Postoperative Complications/prevention & control , Venous Thromboembolism/prevention & control , Adult , Double-Blind Method , Female , Humans , Male , Middle Aged , Postoperative Period
10.
Thromb Haemost ; 121(12): 1684-1695, 2021 12.
Статья в английский | MEDLINE | ID: covidwho-1171416

Реферат

Coronavirus disease-2019 (COVID-19) has been associated with significant risk of venous thromboembolism (VTE), arterial thromboembolism (ATE), and mortality particularly among hospitalized patients with critical illness and elevated D-dimer (Dd) levels. Conflicting data have yet to elucidate optimal thromboprophylaxis dosing. HEP-COVID (NCT04401293) is a phase 3, multicenter, pragmatic, prospective, randomized, pseudo-blinded, active control trial to evaluate efficacy and safety of therapeutic-dose low-molecular-weight heparin (LMWH) versus prophylactic-/intermediate-dose LMWH or unfractionated heparin (UFH) for prevention of a primary efficacy composite outcome of VTE, ATE, and all-cause mortality 30 ± 2 days post-enrollment. Eligible patients have COVID-19 diagnosis by nasal swab or serologic testing, requirement for supplemental oxygen per investigator judgment, and Dd >4 × upper limit of normal (ULN) or sepsis-induced coagulopathy score ≥4. Subjects are randomized to enoxaparin 1 mg/kg subcutaneous (SQ)/two times a day (BID) (creatinine clearance [CrCl] ≥ 30 mL/min) or 0.5 mg/kg (CrCl 15-30 mL/min) versus local institutional prophylactic regimens including (1) UFH up to 22,500 IU (international unit) daily (divided BID or three times a day), (2) enoxaparin 30 and 40 mg SQ QD (once daily) or BID, or (3) dalteparin 2,500 IU or 5,000 IU QD. The principal safety outcome is major bleeding. Events are adjudicated locally. Based on expected 40% relative risk reduction with treatment-dose compared with prophylactic-dose prophylaxis, 308 subjects will be enrolled (assuming 20% drop-out) to achieve 80% power. Distinguishing design features include an enriched population for the composite endpoint anchored on Dd >4 × ULN, stratification by intensive care unit (ICU) versus non-ICU, and the ability to capture asymptomatic proximal deep venous thrombosis via screening ultrasonography prior to discharge.


Тема - темы
Anticoagulants/administration & dosage , COVID-19/drug therapy , Enoxaparin/administration & dosage , Thromboembolism/drug therapy , Anticoagulants/adverse effects , COVID-19/complications , COVID-19/diagnosis , Clinical Trials, Phase III as Topic , Enoxaparin/adverse effects , Humans , Pragmatic Clinical Trials as Topic , Prospective Studies , Risk Assessment , Risk Factors , Thromboembolism/diagnosis , Thromboembolism/etiology , Time Factors , Treatment Outcome , United States , Venous Thromboembolism/diagnosis , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control
11.
J Thromb Thrombolysis ; 52(2): 493-496, 2021 Aug.
Статья в английский | MEDLINE | ID: covidwho-1159474

Реферат

Coronavirus is a source of deep venous thrombosis (DVT) due to complications such as over-coagulation, blood stasis, and endothelial damage. Ovarian vein thrombosis (OVT) is a very serious and rare disease. In this study, we report tow rare case of women with coronavirus who were hospitalized with a right ovarian vein thrombosis mimicking acute abdomen who progressed well on anticoagulation. Our report adds further document in Side effects and rare localisation of obstruction of veins and arteries in patient with corona virus.


Тема - темы
Abdomen, Acute , COVID-19/complications , Enoxaparin/administration & dosage , Ovary/blood supply , Puerperal Disorders , Venous Thrombosis , Abdomen, Acute/diagnosis , Abdomen, Acute/etiology , Adult , Anticoagulants/administration & dosage , COVID-19/blood , COVID-19/diagnosis , COVID-19/physiopathology , COVID-19/therapy , Diagnosis, Differential , Female , Fibrin Fibrinogen Degradation Products/analysis , Humans , Male , Middle Aged , Puerperal Disorders/blood , Puerperal Disorders/etiology , Puerperal Disorders/physiopathology , Puerperal Disorders/therapy , SARS-CoV-2/isolation & purification , Tomography, X-Ray Computed/methods , Treatment Outcome , Veins/diagnostic imaging , Veins/pathology , Venous Thrombosis/blood , Venous Thrombosis/etiology , Venous Thrombosis/physiopathology , Venous Thrombosis/therapy
12.
J Thromb Thrombolysis ; 52(3): 782-790, 2021 Oct.
Статья в английский | MEDLINE | ID: covidwho-1111318

Реферат

A pro-thrombotic milieu and a higher risk of thrombotic events were observed in patients with CoronaVirus disease-19 (COVID-19). Accordingly, recent data suggested a beneficial role of low molecular weight heparin (LMWH), but the optimal dosage of this treatment is unknown. We evaluated the association between prophylactic vs. intermediate-to-fully anticoagulant doses of enoxaparin and in-hospital adverse events in patients with COVID-19. We retrospectively included 436 consecutive patients admitted in three Italian hospitals. Outcome according to the use of prophylactic (4000 IU) vs. higher (> 4000 IU) daily dosage of enoxaparin was evaluated. The primary end-point was in-hospital death. Secondary outcome measures were in-hospital cardiovascular death, venous thromboembolism, new-onset acute respiratory distress syndrome (ARDS) and mechanical ventilation. A total of 287 patients (65.8%) were treated with the prophylactic enoxaparin regimen and 149 (34.2%) with a higher dosing regimen. The use of prophylactic enoxaparin dose was associated with a similar incidence of all-cause mortality (25.4% vs. 26.9% with the higher dose; OR at multivariable analysis, including the propensity score: 0.847, 95% CI 0.400-0.1.792; p = 0.664). In the prophylactic dose group, a significantly lower incidence of cardiovascular death (OR 0.165), venous thromboembolism (OR 0.067), new-onset ARDS (OR 0.454) and mechanical intubation (OR 0.150) was observed. In patients hospitalized for COVID-19, the use of a prophylactic dosage of enoxaparin appears to be associated with similar in-hospital overall mortality compared to higher doses. These findings require confirmation in a randomized, controlled study.


Тема - темы
Anticoagulants/administration & dosage , COVID-19/therapy , Enoxaparin/administration & dosage , Hospitalization , Thromboembolism/prevention & control , Aged , Aged, 80 and over , Anticoagulants/adverse effects , COVID-19/blood , COVID-19/diagnosis , COVID-19/mortality , Enoxaparin/adverse effects , Female , Hospital Mortality , Humans , Italy , Male , Middle Aged , Protective Factors , Respiration, Artificial , Retrospective Studies , Risk Assessment , Risk Factors , Thromboembolism/blood , Thromboembolism/diagnosis , Thromboembolism/mortality , Time Factors , Treatment Outcome
15.
Intern Emerg Med ; 16(5): 1223-1229, 2021 08.
Статья в английский | MEDLINE | ID: covidwho-1002167

Реферат

We conducted an observational cohort study in adult patients consecutively admitted for the respiratory illness Covid-19 to our hub hospital from March 9 to April 7, 2020. The high observed rate of venous thromboembolism prompted us to increase the prophylactic doses of enoxaparin from 40 mg daily up to 1 mg/kg twice daily in patients admitted to intensive care units (ICU), 0.7 mg/kg twice daily in high-intensity of care wards and 1 mg/kg daily in low-intensity of care wards. Patients on high enoxaparin doses were compared to those who received prophylaxis with the standard dosage. Efficacy endpoints were mortality, clinical deterioration, and the occurrence of venous thromboembolism, safety endpoint was the occurrence of major bleeding. Of 278 patients with Covid-19, 127 received prophylaxis with high enoxaparin doses and 151 with standard dosage. At 21 days, the incidence rate of death and clinical deterioration were lower in patients on higher doses than in those on the standard dosage (hazard ratio 0.39, 95% confidence interval 0.23-0.62), and the incidence of venous thromboembolism was also lower (hazard ratio 0.52, 95% confidence interval 0.26-1.05). Major bleeding occurred in four of 127 patients (3.1%) on the high enoxaparin dosage. In conclusion, in the cohort of patients with Covid-19 treated with high enoxaparin dosages we observed a 60% reduction of mortality and clinical deterioration and a 50% reduction of venous thromboembolism compared to standard dosage prophylaxis. However, 3% of patients on high enoxaparin dosages had non-fatal major bleeding.


Тема - темы
COVID-19/drug therapy , Heparin, Low-Molecular-Weight/administration & dosage , Hospitalization/statistics & numerical data , Pre-Exposure Prophylaxis/classification , Aged , Body Mass Index , COVID-19/mortality , Cohort Studies , Enoxaparin/administration & dosage , Enoxaparin/classification , Female , Heparin, Low-Molecular-Weight/classification , Humans , Male , Middle Aged , Pre-Exposure Prophylaxis/methods , Pre-Exposure Prophylaxis/statistics & numerical data , Venous Thromboembolism/prevention & control
17.
J Med Case Rep ; 14(1): 188, 2020 Oct 15.
Статья в английский | MEDLINE | ID: covidwho-863352

Реферат

BACKGROUND: Currently, there is minimal data available highlighting the prevalence of venous thromboembolism in patients infected with coronavirus disease 2019 (COVID-19). This case report with a literature review emphasizes a unique presentation of COVID-19 that is highly important for health care providers to consider when treating their patients. CASE REPORT: A 65-year-old Caucasian male patient presented to the emergency department with a 2-day history of dyspnea on exertion after his wife's recent diagnosis of COVID-19. He additionally had experienced a couple of episodes of self-resolving diarrhea a few days before presentation. Based on the patient's clinical presentation and the laboratory workup identifying an elevated D-dimer, a computed tomography angiogram of the chest was obtained, which was significant for moderately large, bilateral pulmonary emboli with a saddle embolus, and an associated small, left lower lobe, pulmonary infarct. Ultrasound of the lower extremity showed non-occlusive deep vein thrombosis at the distal left femoral vein to the left popliteal vein. The patient was additionally diagnosed with COVID-19 when the results of the COVID-19 polymerase chain reaction test returned as positive. The patient was admitted to the COVID unit, and he was started on an intravenously administered, unfractionated heparin drip for management of his bilateral pulmonary emboli and deep vein thrombosis. The patient's clinical condition improved significantly with anticoagulation, and he was observed in the hospital for 3 days, after which he was discharged home on the enoxaparin bridge with warfarin. Post-discharge telephone calls at day 10 and week 4 revealed that the patient was appropriately responding to anticoagulation treatment and had no recurrence of his symptoms related to venous thromboembolism and COVID-19. CONCLUSION: As COVID-19 continues to lead to significant mortality, more data is emerging that is exposing its perplexing pathogenicity. Meanwhile, the presentation of venous thromboembolism in patients with COVID-19 remains an unusual finding. It is imperative for health care providers to be mindful of this unique association to make necessary diagnostic evaluations and provide appropriate treatment for the patients.


Тема - темы
Coronavirus Infections , Enoxaparin/administration & dosage , Femoral Vein/diagnostic imaging , Heparin/administration & dosage , Pandemics , Pneumonia, Viral , Pulmonary Embolism , Venous Thromboembolism , Warfarin/administration & dosage , Aged , Anticoagulants/administration & dosage , Betacoronavirus/isolation & purification , COVID-19 , Computed Tomography Angiography/methods , Coronavirus Infections/blood , Coronavirus Infections/complications , Coronavirus Infections/diagnosis , Fibrin Fibrinogen Degradation Products/analysis , Hospitalization , Humans , Lung/diagnostic imaging , Male , Pneumonia, Viral/blood , Pneumonia, Viral/complications , Pneumonia, Viral/diagnosis , Pulmonary Embolism/diagnosis , Pulmonary Embolism/etiology , Pulmonary Embolism/therapy , SARS-CoV-2 , Treatment Outcome , Ultrasonography/methods , Venous Thromboembolism/diagnosis , Venous Thromboembolism/etiology , Venous Thromboembolism/therapy
20.
Thromb Res ; 196: 382-394, 2020 12.
Статья в английский | MEDLINE | ID: covidwho-791550

Реферат

BACKGROUND: Microvascular and macrovascular thrombotic events are among the hallmarks of coronavirus disease 2019 (COVID-19). Furthermore, the exuberant immune response is considered an important driver of pulmonary and extrapulmonary manifestations of COVID-19. The optimal management strategy to prevent thrombosis in critically-ill patients with COVID-19 remains unknown. METHODS: The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) and INSPIRATION-statin (INSPIRATION-S) studies test two independent hypotheses within a randomized controlled trial with 2 × 2 factorial design. Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation. The 600 patients undergoing this randomization will be screened and if meeting the eligibility criteria, will undergo an additional double-blind stratified randomization to atorvastatin 20 mg daily versus matching placebo. The primary endpoint, for both hypotheses will be tested for superiority and includes a composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death within 30 days from enrollment. Key secondary endpoints include all-cause mortality, adjudicated VTE, and ventilator-free days. Key safety endpoints include major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL) for the anticoagulation hypothesis. In a prespecified secondary analysis for non-inferiority, the study will test for the non-inferiority of intermediate intensity versus standard dose anticoagulation for major bleeding, considering a non-inferiority margin of 1.8 based on odds ratio. Key safety endpoints for the statin hypothesis include rise in liver enzymes >3 times upper normal limit and clinically-diagnosed myopathy. The primary analyses will be performed in the modified intention-to-treat population. Results will be tested in exploratory analyses across key subgroups and in the intention-to-treat and per-protocol cohorts. CONCLUSIONS: INSPIRATION and INSPIRATON-S studies will help address clinically-relevant questions for antithrombotic therapy and thromboinflammatory therapy in critically-ill patients with COVID-19.


Тема - темы
Anticoagulants/administration & dosage , Atorvastatin/administration & dosage , COVID-19/drug therapy , Enoxaparin/administration & dosage , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Thrombosis/prevention & control , Venous Thromboembolism/prevention & control , Anticoagulants/adverse effects , Atorvastatin/adverse effects , COVID-19/complications , COVID-19/diagnosis , Critical Illness , Double-Blind Method , Enoxaparin/adverse effects , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Iran , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Thrombosis/diagnosis , Thrombosis/etiology , Time Factors , Treatment Outcome , Venous Thromboembolism/diagnosis , Venous Thromboembolism/etiology
Критерии поиска