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1.
Int Orthop ; 38(2): 347-54, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24318318

RESUMO

PURPOSE: Our aim was to clarify the effective decrease in blood transfusion after primary total knee arthroplasty (TKA) from a multimodal blood-loss prevention approach (MBLPA) and the related risk factors of blood transfusion. METHODS: We retrospectively compared the rate of postoperative blood transfusion in 418 cases of primary TKA during 2010 from a single institution with two different groups of patients, allocating cases to the group with MBLPA (group 1, study group, N = 71) and controls to the group without MBLPA (group 2, standard group, N = 347). MBLPA procedure included pre-operative haemoglobin (Hb) optimisation; femoral canal obturation; limited incision and release; peri- and intra-articular use of saline with adrenalin, morpheic chloride, tobramycin, betamethasone and ropivacaine; tourniquet release after skin closure; 24 hour drain under atmospheric pressure; and two doses of tranexamic acid (TXA) i.v.. In the control group, surgeons followed the standard procedure without blood-saving techniques. Case-control comparison and blood transfusion risk factors were analysed. RESULTS: Group 1 had a zero transfusion rate (0/71), whereas 27.4% of patients (95/347) in group 2 received allogenic blood transfusion. Significant transfusion risk factors were pre-operative Hb <12 g/dl), American Society of Anesthesiologists (ASA) status III and nonobese body mass index (BMI); Age and gender were not significant risk factors. CONCLUSIONS: MBLPA in primary TKA was highly effective, with a zero transfusion rate. Risk factors for transfusion were determined, and eliminating them contributed to the avoidance of allogeneic blood transfusion in our study series.


Assuntos
Antifibrinolíticos/uso terapêutico , Artroplastia do Joelho/métodos , Perda Sanguínea Cirúrgica/prevenção & controle , Transfusão de Sangue/estatística & dados numéricos , Drenagem/métodos , Hemoglobinas/metabolismo , Ácido Tranexâmico/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Índice de Massa Corporal , Estudos de Casos e Controles , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Torniquetes , Resultado do Tratamento
2.
J Bone Joint Surg Am ; 96(23): 1937-44, 2014 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-25471907

RESUMO

BACKGROUND: Abundant literature regarding the use of intravenous tranexamic acid (TXA) in primary total knee replacement is available. Randomized controlled trials have confirmed the efficacy of topical TXA compared with placebo, but the comparison between topical and intravenous TXA is unclear. The present study was designed to verify noninferior efficacy and safety of topical intra-articular TXA compared with intravenous TXA in primary total knee replacement with cemented implants. METHODS: A Phase-III, single-center, double-blind, randomized, controlled clinical trial was performed to compare topical intra-articular TXA (3 g of TXA in 100 mL of physiological saline solution) with two intravenous doses of TXA (15 mg/kg in 100 mL of physiological saline solution, one dose before tourniquet release and another three hours after surgery) in a multimodal protocol for blood loss prevention. The primary outcome was the blood transfusion rate, and the secondary outcomes included visible blood loss (as measured in the drain) at twenty-four hours postoperatively and invisible blood loss (as estimated from the Nadler formula) at forty-eight hours postoperatively. The sample size of seventy-eight patients was calculated to give a statistical power of 99% for demonstrating noninferiority. Thirty-nine patients each were allocated to receive topical intra-articular TXA (the experimental group) and intravenous TXA (the control group); there were no significant differences in demographics or preoperative laboratory values between the groups. Noninferiority was estimated by comparing the confidence intervals with a delta of 10%. Student t and Mann-Whitney tests were used to assess the significance of any differences. RESULTS: The transfusion rate was zero in both groups; thus, noninferiority was demonstrated for the primary efficacy end point, suggesting equivalence. Noninferiority was also demonstrated for the secondary efficacy end points. Drain blood loss at twenty-four hours was 315.6 mL (95% confidence interval [CI], 248.5 to 382.7 mL) in the experimental group and 308.1 mL (95% CI, 247.6 to 368.5 mL) in the control group (p = 0.948, Mann-Whitney). Also, estimated blood loss at forty-eight hours was 1259.0 mL (95% CI, 1115.6 to 1402.3 mL) in the experimental group and 1317.9 mL (95% CI, 1175.4 to 1460.4 mL) in the control group (p = 0.837, Mann-Whitney). No significant safety differences were seen between groups. CONCLUSIONS: Topical administration of TXA according to the described protocol demonstrated noninferiority compared with intravenous TXA, with no safety concerns. This randomized controlled trial supports the topical intra-articular administration of TXA in primary total knee replacement with cemented implants. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.


Assuntos
Antifibrinolíticos/administração & dosagem , Artroplastia do Joelho , Perda Sanguínea Cirúrgica/prevenção & controle , Ácido Tranexâmico/administração & dosagem , Administração Intravenosa , Idoso , Idoso de 80 Anos ou mais , Antifibrinolíticos/uso terapêutico , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Transfusão de Sangue/estatística & dados numéricos , Método Duplo-Cego , Feminino , Humanos , Injeções Intra-Articulares , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Ácido Tranexâmico/uso terapêutico , Resultado do Tratamento
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