Short and long-term menstrual, reproductive, and mental health outcomes after the intrauterine use of chitosan tamponade or the Bakri balloon for severe postpartum hemorrhage: an observational study.

OBJECTIVE: This retrospective follow-up study analyzes the effect of intrauterine postpartum hemorrhage (PPH) therapy on menstrual, reproductive, and mental health outcomes. METHODS: All women who delivered at a university hospital between 2016 and 2021 with PPH and who needed intrauterine therapy were included. A questionnaire on well-being, menses, fertility, and reproductive outcomes was mailed to the patients. Those who did not reply were surveyed by telephone. RESULTS: A total of 214 women treated with chitosan-covered gauze (group A) and 46 women treated with a balloon tamponade (group B) were recruited, and their short-term courses were analyzed. For long-term follow-up, 71 women of group A (33%) and 21 women of group B (46%) could be reached. A total of 89% of group A and 95% of group B had regular menstrual bleeding in the most recent 12 months; 27% (group A) and 29% (group B) were trying to conceive again, and all of them did so successfully. There were 12 deliveries, 3 ongoing pregnancies, 3 miscarriages, and 2 terminations of pregnancies (TOP) in group A and 4 deliveries, 1 miscarriage, and 2 TOPs in group B. More than half of our study participants was sorted into grade II or III of the Impact of Events Scale, indicating they experienced clinical impacts in the form of psychological sequelae. One-quarter of patients had symptoms of post-traumatic stress disorder. CONCLUSION: Chitosan gauze as well as balloon tamponade appear to have few adverse effects on subsequent menstrual and reproductive function. Women after PPH are at increased risk of long-term adverse psychological outcomes.

Granular Hemostatic Composite of Alginate, Calcium, and Zinc for Rapid and Effective Management of Post-Traumatic Hemorrhage.

Post-traumatic hemorrhage, which can result from accidents or battlefield injuries, is a significant global concern due to the high prehospital mortality rate. Substantial efforts have been made to develop hemostatic agents that can effectively reduce hemorrhage in the immediate aftermath of a traumatic event. The present study investigated the potential efficacy of Ca2+ and Zn2+ supplemented sodium alginate-based dry hemostatic particles (SA-CZ DHP) to manage excessive blood loss or post-traumatic hemorrhage. SA-CZ DHP were developed, followed by their physical and biochemical characterization, cytocompatibility and hemocompatibility testing, and critical evaluation of the hemostatic potential in vitro and in vivo. The safe SA-CZ DHP showed high absorption and accelerated blood clotting kinetics with reduced coagulation time (≈70%, p < 0.0001) in whole human blood, observed with insignificant hemolysis and uninterrupted RBC morphology. SA-CZ DHP significantly reduced the mean blood loss (≈90% in SD rats tail incision), and bleeding time (≈60% in BALB/c mice tail incision) was at par with commercially available Celox hemostatic granules. In conclusion, the biocompatible SA-CZ DHP exhibited rapid and effective management of excessive blood loss. It is also pertinent to note that the developed formulation could be a cost-effective alternative to its commercial counterparts.

Spinal epidural fibrosis following hemostatic agent employment.

OBJECTIVE: Failed Back Surgery Syndrome (FBSS) refers to a subset of patients who have new or persistent pain after spinal surgery for back or leg pain. Epidural fibrosis (EF) is a common cause of FBSS. Many agents aiming to prevent EF have been tested. However, hemostatic agents are readily available at hospitals, easy to reach and frequently used. For these reasons, oxidized regenerated cellulose, polysaccharide hemostat, hemostatic thrombin-gelatin matrix and chitosan linear polymer were evaluated for their effects on epidural fibrosis on rats after laminectomy. METHODS: 40 Sprague-Dawley rats were randomly divided into 5 equal groups including the control group where only the laminectomy was performed. The other 4 groups received hemostatic agents after laminectomy. The rats were euthanized 45 days later and were assessed by a blinded observer to grade the fibrosis level. RESULTS: The study revealed that oxidized regenerated cellulose, polysaccharide hemostat and hemostatic thrombin-gelatin matrix lowered the epidural fibrosis grade which was statistically significant (p < 0.001). Although chitosan linear polymer created fibrosis similar to the control group it was not proven to be statistically significant (p = 0.8999). However, when compared with other hemostatic agents it resulted in a higher fibrosis grade (p < 0.001). CONCLUSION: The results obtained from this experimental study revealed that Pahacel, Sealfoam and Surgiflo, were effective in reducing epidural fibrosis after laminectomy in rats.

Novel Management of a Femoral Fracture in Klippel-Trenaunay Syndrome.

Klippel-Trenaunay syndrome (KTS) is a rare congenital disorder with a clinical triad of capillary malformations, vascular abnormalities, and bone/soft tissue hypertrophy. This is the first case of closed femoral shaft fracture in a patient with KTS managed by flexible intramedullary nails. A 34-year-old patient sustained a right femoral mid-shaft spiral fracture after slipping on the grass. Due to a very narrow femur and large venous malformations, nail or plate fixation was impossible. Surgery was conducted using flexible intramedullary (TENS) nails with good reduction but significant bleeding which was controlled with tranexamic acid and CELOX. The patient required 4 units of red blood cells, 3 units of fresh frozen plasma, and 900 mL of cell saver intraoperatively with a further 2 units of RBC post-op. Fracture union was achieved 14 months after the initial fracture with additional pulsed ultrasound therapy. Bleeding from vascular malformations during surgery makes operative management challenging in KTS patients. Previous studies have reported a variety of management strategies to achieve fracture fixation and union including IM nailing, plate fixation, and external fixators, but encountered significant bleeding of up to 10 units and 15 units, respectively. Ultrasound therapy has been utilized as a useful adjunct in lower limb fracture with delayed therapy. Management of fractures in patients affected by KTS is extremely challenging despite extensive workup and planning to evaluate the optimal fixation method and explore strategies to reduce the risk of intra-operative bleeding. Management strategies should be tailored to the patient with close follow-up to assess fracture union.

Uterine packing with chitosan-covered gauze compared to balloon tamponade for managing postpartum hemorrhage.

BACKGROUND: Postpartum hemorrhage (PPH) is a major cause of maternal death worldwide. Management of PPH includes the administration of uterotonics, and intrauterine packing techniques. OBJECTIVE: In this study the effectiveness and safety of chitosan covered gauze versus a balloon tamponade for managing severe PPH should be assessed. STUDY DESIGN: This retrospective cohort study was conducted at the Department of Obstetrics, Charité, university hospital Berlin, between October 2016 and June 2018. Women with PPH were treated according to management guidelines. When bleeding persisted, we applied additional uterine packing with either chitosan covered gauze or a balloon tamponade. The primary outcome was uterine bleeding termination without additional surgical interventions. Secondary outcomes included the amount of blood loss, the amount of blood transfusions and maternal complications. RESULTS: Among the 78 patients included in this study, 47 (60.3%) received chitosan covered gauze tamponade and 31 (39.7%) received a balloon tamponade. The major reason for PPH was atonic bleeding, no statistically significant group differences were observed. With respect to the outcomes monitored, the groups were not significantly different in postpartum vital signs, hemoglobin levels, blood loss, admission to intensive care unit, or inflammation parameters. However, three patients in balloon tamponade group required a hysterectomy. No hysterectomy was required in gauze group. CONCLUSION: Chitosan covered gauze is an excellent option for treating PPH, it appeared to be at least equivalent to the balloon tamponade, in our experience particularly suitable for atony or placenta bed bleeding after spontaneous delivery or during cesarean sections, in cases of lower uterine segment atony, placenta previa bed bleeding, and/or coagulopathy.

Assessing Coagulation by Rotational Thromboelastometry (ROTEM) in Rivaroxaban-Anticoagulated Blood Using Hemostatic Agents.

Introduction The use of direct oral anticoagulants (DOACs) such as rivaroxaban (Xarelto) is increasingly common. However, therapies for reversing anticoagulation in the event of hemorrhage are limited. This study investigates the ability of hemostatic agents to improve the coagulation of rivaroxaban-anticoagulated blood, as measured by rotational thromboelastometry (ROTEM). Hypothesis/Problem If a chitosan-based hemostatic agent (Celox), which works independently of the clotting cascade, is applied to rivaroxaban-anticoagulated blood, it should improve coagulation by decreasing clotting time (CT), decreasing clot formation time (CFT), and increasing maximum clot firmness (MCF). If a kaolin-based hemostatic agent (QuikClot Combat Gauze), which works primarily by augmenting the clotting cascade upstream of factor Xa (FXa), is applied to rivaroxaban-anticoagulated blood, it will not be effective at improving coagulation. METHODS: Patients (age >18 years; non-pregnant) on rivaroxaban, presenting to the emergency department (ED) at two large, university-based medical centers, were recruited. Subjects (n=8) had blood drawn and analyzed using ROTEM with and without the presence of a kaolin-based and a chitosan-based hemostatic agent. The percentage of patients whose ROTEM parameters responded to the hemostatic agent and percent changes in coagulation parameters were calculated. RESULTS: Data points analyzed included: CT, CFT, and MCF. Of the samples treated with a kaolin-based hemostatic agent, seven (87.5%) showed reductions in CT, eight (100.0%) showed reductions in CFT, and six (75.0%) showed increases in MCF. The average percent change in CT, CFT, and MCF for all patients was 32.5% (Standard Deviation [SD]: 286; Range:-75.3 to 740.7%); -66.0% (SD:14.4; Range: -91.4 to -44.1%); and 4.70% (SD: 6.10; Range: -4.8 to 15.1%), respectively. The corresponding median percent changes were -68.1%, -64.0%, and 5.2%. Of samples treated with a chitosan-based agent, six (75.0%) showed reductions in CT, three (37.5%) showed reductions in CFT, and five (62.5%) showed increases in MCF. The average percent changes for CT, CFT, and MCF for all patients were 165.0% (SD: 629; Range:-96.9 to 1718.5%); 139.0% (SD: 174; Range: -83.3 to 348.0%); and -8.38% (SD: 32.7; Range:-88.7 to 10.4%), respectively. The corresponding median percent changes were -53.7%, 141.8%, and 3.0%. CONCLUSIONS: Rotational thromboelastometry detects changes in coagulation parameters caused by hemostatics applied to rivaroxaban-anticoagulated blood. These changes trended in the direction towards improved coagulability, suggesting that kaolin-based and chitosan-based hemostatics may be effective at improving coagulation in these patients. Bar J , David A , Khader T , Mulcare M , Tedeschi C . Assessing coagulation by rotational thromboelastometry (ROTEM) in rivaroxaban-anticoagulated blood using hemostatic agents. Prehosp Disaster Med. 2017;32(5):580-587.

Topical and effective hemostatic medicines in the battlefield.

Uncontrolled hemorrhage has been considered as one of the most important factors for causing death on the battlefront. If given timely and efficient hemostatic medicines in pre-hospital setting, patients will obtain more time and chance to wait for medical treatment so as to save their lives. However, there is not a certain answer about which kind of hemostatic drugs can achieve efficacious effect to hemostasis in the battle. This review aims to summarize effective hemostatic medicines applied in battlefield from 41 articles. After analyzing and comparing the efficacy and complications of those products, we conclude that Fibrin Sealant Dressing, Celox and Woundstat are prior to other materials to stanch life-threatening extremity hemorrhage on the battlefield based on present research in the related area. Therefore, in the prevalence of some inevitable battlefield throughout the world, especially in the Middle Eastern countries, our findings suggest for the first time that the effective hemostatic device is not only a key point to link pre-hospital and hospital care but also an essential way to increase the survival rate of battlefront in the foreseeable future.

Effects of Ankaferd Blood Stopper and Celox on the tissue factor activities of warfarin-treated rats.

The aim of this study is to evaluate the effect of these new generation hemostatic agents on early-stage soft tissue healing of warfarin-treated rats by measuring the tissue factor (TF) activities. Rats in the warfarin group were treated intraperitonally with 0.1 mg/kg warfarin, and rats in the control group were treated with 1 mL/kg saline. All rats had 3 incisions on dorsal dermal tissue applied Celox, Ankaferd Blood Stopper (ABS), or no hemostatic agent. Six rats from each group were killed on day 4, and the other 6 were killed on day 8. Prothrombin time (PT) and TF activities were evaluated, respectively. Both the hemostatic agents positively affected the hemostasis. Warfarin treatment increased the PT levels as expected. Celox-treated dermal tissues had higher TF activity when compared to ABS-treated ones. The ABS affected the early-stage healing positively in clinical aspect, whereas Celox was more effective on hemostasis by means of increasing TF activities.