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Prehospital synergy: Tranexamic acid and blood transfusion in patients at risk for hemorrhage
Deeb AP, Hoteit L, Li S, Guyette FX, Eastridge BJ, Nirula R, Vercruysse GA, O'Keeffe T, Joseph B, Neal MD, et al
The journal of trauma and acute care surgery. 2022
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Abstract
BACKGROUND Growing evidence supports improved survival with prehospital blood products. Recent trials show a benefit of prehospital tranexamic acid (TXA) administration in select subgroups. Our objective was to determine if receiving prehospital packed red blood cells (pRBC) in addition to TXA improved survival in injured patients at risk of hemorrhage. METHODS We performed a secondary analysis of all scene patients from the STAAMP trial. Patients were randomized to prehospital TXA or placebo. Some participating EMS services utilized pRBC. Four resuscitation groups resulted: TXA, pRBC, pRBC+TXA, and neither. Our primary outcome was 30-day mortality and secondary outcome was 24-hour mortality. Cox regression tested the association between resuscitation group and mortality while adjusting for confounders. RESULTS A total of 763 patients were included. Patients receiving prehospital blood had higher injury severity scores in the pRBC (22 [10, 34]) and pRBC+TXA (22 [17, 36]) groups than the TXA (12 [5, 21]) and neither (10 [4, 20]) groups (p < 0.01). Mortality at 30 days was greatest in the pRBC+TXA and pRBC groups at 18.2% and 28.6% compared to the TXA only and neither groups at 6.6% and 7.4% respectively. Resuscitation with pRBC+TXA was associated with a 35% reduction in relative hazards of 30-day mortality compared to neither (HR 0.65; 95%CI 0.45-0.94, p = 0.02). No survival benefit was observed in 24-hour mortality for pRBC+TXA, but pRBC alone was associated with a 61% reduction in relative hazards of 24 h mortality compared to neither (HR 0.39; 95%CI 0.17-0.88, p = 0.02). CONCLUSIONS For injured patients at risk of hemorrhage, prehospital pRBC+TXA is associated with reduced 30-day mortality. Use of pRBC transfusion alone was associated with a reduction in early mortality. Potential synergy appeared only in longer term mortality and further work to investigate mechanisms of this therapeutic benefit is needed to optimize the prehospital resuscitation of trauma patients. LEVEL OF EVIDENCE Therapeutic, Level III.
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EXPRESS: Safety and Efficacy of Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage: A Proof-of-Concept Randomized Controlled Trial
Zhao W, Jiang F, Li S, Liu G, Wu C, Wang Y, Ren C, Zhang J, Gu F, Zhang Q, et al
International journal of stroke : official journal of the International Stroke Society. 2021;:17474930211006580
Abstract
Background Remote ischemic conditioning (RIC) can promote hematoma resolution, attenuate brain edema, and improve neurological recovery in animal models of intracerebral hemorrhage (ICH). Aims This study aimed to evaluate the safety and preliminary efficacy of RIC in patients with ICH.Methods In this multicenter, randomized, controlled trial, 40 subjects with supratentorial ICH presenting within 24-48 hours of onset were randomly assigned to receive medical therapy plus RIC for consecutive 7 days or medical therapy alone. The primary safety outcome was neurological deterioration within 7 days of enrollment, and the primary efficacy outcome was the changes of hematoma volume on CT images. Other outcomes included hematoma resolution rate at 7 d ([hematoma volume at 7 d â hematoma volume at baseline]/hematoma volume at baseline), perihematomal edema (PHE), and functional outcome at 90 days. Results The mean age was 59.3±11.7 years and hematoma volume was 13.9±4.5 mL. No subjects experienced neurological deterioration within 7 days of enrollment, and no subject died or experienced RIC-associated adverse events during the study period. At baseline, the hematoma volumes were 14.19±5.07 mL in the control group and 13.55±3.99 mL in the RIC group, and they were 8.54±3.99 mL and 6.95±2.71 mL at 7 days after enrollment, respectively, not a significant difference (p>0.05 each). The hematoma resolution rate in the RIC group (49.25±9.17%) was significantly higher than in the control group (41.92±9.14%; MD, 7.3%; 95% CI, 1.51% to 13.16%; p=0.015). The absolute PHE volume was 17.27±8.34 mL in the control group and 12.92±7.30 mL in the RIC group at 7 days after enrollment, not a significant between-group difference (p=0.087), but the relative PHE in the RIC group (1.77±0.39) was significantly lower than in the control group (2.02±0.27; MD, 0.25; 95% CI, 0.39-0.47; p=0.023). At 90-day follow-up, 13 subjects (65%) in the RIC group and 12 subjects (60%) in the control group achieved favorable functional outcomes (mRS scoreâ¤3), not a significant between-group difference (p=0.744).Conclusions Repeated daily RIC for consecutive 7 days was safe and well-tolerated in patients with ICH, and it may be able to improve hematoma resolution rate and reduce relative PHE. However, effects RIC on the absolute hematoma and PHE volume and functional outcomes in this patient population need further investigations.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03930940.
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Tranexamic acid reduce hidden blood loss in posterior lumbar interbody fusion (PLIF) surgery
Xu D, Chen X, Li Z, Ren Z, Zhuang Q, Li S
Medicine (Baltimore). 2020;99(11):e19552
Abstract
BACKGROUND Posterior lumbar interbody fusion (PLIF) surgery is associated with significant blood loss; however, few studies have focused on hidden blood loss (HBL) in PLIF or its regulatory factors. The purpose of this study was to explore the HBL in PLIF surgery as well as the influence of tranexamic acid (TXA) on blood loss in PLIF. METHODS We performed a randomized controlled trial (RCT) and recruited patients undergoing PLIF into the study from November 2013 to April 2017. All participants were assigned to one of 2 groups according to a simple equal probability randomization scheme. At the end of PLIF surgery, for patients in the TXA group, the surgical field was immersed in TXA (1 g in 100 mL of saline solution) for 5 min before stitching the wound. For the control group, the surgical field was immersed in the same volume of normal saline. RESULTS In our study, the drainage volume during the first 24 h and the total postoperative drainage volume were significantly lower in patients in the TXA group than in the control group (P = .001). The hematocrit (Hct) of the drainage and calculation of blood contained in the drainage showed similar results. The mean length of hospital stay and rate of blood transfusion in the TXA group were less than those in the control group (P < .05). HBL was responsible for 45.6% of the total blood loss in PLIF, and both of the indicators in the TXA group were much lower than those in the control group. CONCLUSIONS PLIF is associated with massive perioperative HBL, but the application of topical TXA leads to less postoperative blood loss including less HBL, a lower blood product transfusion rate, and a shorter hospital stay for PLIF.
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Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study
Li S, Yang J, Watson C, Lu Q, Zhang M, Miao Z, Luo D, Liu P
Int Orthop. 2020
Abstract
PURPOSE Drainage is a common procedure in high tibial osteotomy (HTO), but the benefits of drainage during HTO remain poorly investigated. This study was designed to investigate the effect of drainage on blood loss and early functional recovery in HTO. METHODS Altogether, 80 patients undergoing HTO were analyzed from August 2018 to September 2019. Patients were randomized into two groups: group A (drainage, n = 40) and group B (no drainage, n = 40). There were no intergroup differences in baseline parameters between the two groups, and the same surgical techniques and haemostatic methods were used. The mean follow-up time was 3.2 months. Blood loss and early functional recovery of the knee were examined post-operatively in both groups. RESULTS The total post-operative blood loss was 253.34 +/- 104.18 ml in group A and 222.51 +/- 106.89 ml in group B. This difference was non-significant (p > 0.05). The post-operative haemoglobin and haematocrit differences between groups were also non-significant (p > 0.05). Post-operative visual analogue scale (VAS) pain scores and lower leg swelling were lower in group A than those in group B (p < 0.05), and the early range of motion of the knee joint was higher in group A than that in group B (p < 0.05). Group A had lower incidence rates of dressing seepage and incision complications than group B (p < 0.05). The differences in three month post-operative VAS and knee function scores were non-significant (p > 0.05). CONCLUSION Drainage in HTO does not increase patients' total blood loss, but it can promote early knee function recovery by reducing post-operative pain, lower leg swelling, and the incidence of incision complications. TRIAL REGISTRATION NCT-03954860.
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A randomized controlled trial on the effects of collagen sponge and topical tranexamic acid in posterior spinal fusion surgeries
Xu D, Zhuang Q, Li Z, Ren Z, Chen X, Li S
Journal of Orthopaedic Surgery and Research. 2017;12((1)):166.
Abstract
BACKGROUND This is a randomized controlled trial research to assess the hemostatic efficacy of gelatin sponge, collagen sponge, and topical use of tranexamic acid (TXA) on postoperative blood loss in posterior spinal fusion surgeries. METHODS We recruited patients with spinal degenerative diseases into the study from November 2013 to October 2016. All the participants were assigned to 3 groups using a simple, equal-probability randomization scheme: group A is a control group utilizing gelatin sponge, while groups B and C are experimental groups, applying collagen hemostatic sponge and topical TXA respectively. Postoperative blood loss, rates of transfusion, and hospitalization were compared among the 3 groups. RESULTS In our study, the volume of drainage and blood content in drainage on the first postoperative day (POD 1) of patients in the experimental groups were significantly less than those in the control group, as well as rates of transfusion and postoperative hospitalization (P < 0.05). When compared with the control group, the volume of drainage decreased by 22.7% in group B and 56.2% in group C, while the blood content in drainage decreased by 28.8 and 75% respectively. CONCLUSIONS In this study, collagen and topical use of TXA have both proven to be effective and safe for patients undergoing posterior spinal fusion surgeries, while TXA has exhibited better efficacy. The total amount of perioperative blood loss reduced significantly without increasing incidence of related complications. TRIAL REGISTRATION A randomized controlled trial for effects of collagen sponge and topical tranexamic acid in posterior lumbar fusion surgeries. ChiCTR-IIR-17010785.
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Hemostatic effect of topical hemocoagulase spray in digestive endoscopy
Wang T, Wang DN, Liu WT, Zheng ZQ, Chen X, Fang WL, Li S, Liang L, Wang BM
World Journal of Gastroenterology. 2016;22((25)):5831-6.
Abstract
AIM: To evaluate the hemostatic effect of topical hemocoagulase spray in digestive endoscopy. METHODS Eighty-nine patients who developed oozing bleeding during endoscopic treatment from September 2014 to October 2014 at Center for Digestive Endoscopy, Tianjin Medical University General Hospital were randomly divided into either a study group (n = 39) or a control group (n = 50). The study group was given topical hemocoagulase spray intraoperatively, while the control group was given traditional 8% norepinephrine spray. Hemostatic efficacy was compared between the two groups. Bleeding site, wound cleanliness and perforation were recorded, and the rates of perforation and late bleeding were compared. RESULTS Successful hemostasis was achieved in 39 (100%) patients of the study group and in 47 (94.0%) patients of the control group, and there was no significant difference in the rate of successful hemostasis between the two groups. Compared with the control group, after topical hemocoagulase spray in the study group, the surgical field was clearer, the bleeding site was more easily identified, and the wound was cleaner. There was no significant difference in the rate of perforation between the study and control groups (16.7% vs 35.0%, P = 0.477), but the rates of late bleeding (0% vs 15.8%, P = 0.048) and overall complications (P = 0.032) were significantly lower in the study group. CONCLUSION Topical hemocoagulase spray has a definite hemostatic effect for oozing bleeding in digestive endoscopy, and this method is convenient, safe, and reliable. It is expected to become a new method for endoscopic hemostasis.
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A randomized controlled trial on effects of different hemostatic sponges in posterior spinal fusion surgeries
Xu D, Ren Z, Chen X, Zhuang Q, Sheng L, Li S
Bmc Surgery. 2016;16((1)):80.
Abstract
BACKGROUND Spinal fusion surgery is associated with significant blood loss, which may result in potential clinical complications, it is necessary to take safe and effective measures to reduce blood loss in surgery. We perform this study to assess the impact of three different hemostatic materials on perioperative blood loss. METHODS We performed a Randomized Controlled Trial research and recruited patients with lumbar disease into the study between November 2013 and March 2015. All the participants were randomly assigned to 3 groups using a simple equal probability randomization scheme: Group A (Stypro hemostatic sponge), Group B (Collagen hemostatic sponge) and Group C (gelatin sponge). We compared postoperative blood loss between these 3 groups. RESULTS In our study, drainage volume in the first 24 h of patients in Group A and B is significantly smaller, as well as total postoperative volumes of drainage (p < 0.05) during their hospital stay. The drainage volumes in the second 24 h were similar in the 3 groups. We also found that the average drainage Hematocrit (HCT) reduced over time, the average HCT of drainage is 18.04% and 11.72% on the first day and on the second day respectively. CONCLUSIONS Hemostatic collagen sponge demonstrated better hemostasis effects than gelatin sponge with lower volume of postoperative drainage volume and blood loss in posterior spinal fusion surgery. TRIAL REGISTRATION The trial registration number (TRN) of the study is ISRCTN29254316 and date of registration is 25/10/2016. Our trial was registered retrospectively.
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Efficacy of a single dose and an additional dose of tranexamic acid in reduction of blood loss in total knee arthroplasty
Sun Q, Yu X, Wu J, Ge W, Cai M, Li S
The Journal of Arthroplasty. 2016;32((7):):2108-2112
Abstract
BACKGROUND This study aimed at evaluating the efficacy and safety of different regimens with a single dose and an additional postoperative dose of tranexamic acid (TA) in reducing blood loss in total knee arthroplasty (TKA). METHODS A total of 180 patients who were scheduled to undergo primary unilateral TKA in our level I trauma center were recorded and divided into groups A, B, C, and D randomly. Preoperative dose, an additional postoperative dose, and 2 postoperative additional doses of TA were infused intravenously in groups A (30 mg/kg), B (15 mg/kg), and C (10 mg/kg), respectively, and TA was not infused in group D. Blood loss (intraoperative, postoperative, and total blood loss), blood transfusion rate and volume, hemoglobin level, and incidence of deep vein thrombosis were analyzed. RESULTS The total blood loss and postoperative blood loss were significantly lower in groups B and C without any difference between them. As for intraoperative blood loss, there was no significant difference between groups A and B and between groups B and C with superior efficacy than group D. CONCLUSION With the same total dose of TA, the preoperative dose and an additional dose of TA were superior to a single preoperative dose of TA in reducing blood loss in TKA. Besides, 1 additional dose was comparable to 2 additional doses of TA in reducing blood loss.
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The influence of cardiopulmonary bypass priming without FFP on postoperative coagulation and recovery in pediatric patients with cyanotic congenital heart disease
Miao X, Liu J, Zhao M, Cui Y, Feng Z, Zhao J, Long C, Li S, Yan F, Wang X, et al
European Journal of Pediatrics. 2014;173((11):):1437-43.
Abstract
UNLABELLED Transfusion guidelines have been produced for the evidence-based use of fresh frozen plasma (FFP). However, the inappropriate use of FFP is still a worldwide problem, especially in the prophylactic settings. In the present study, 100 cyanotic pediatric patients (age 6 months to 3 years) undergoing cardiac surgery with cardiopulmonary bypass (CPB) were randomized to receive either 10-20 ml/kg FFP (FFP group, n=50) or 10-20 ml/kg 4 % succinylated gelatin (Gelofusine, GEL group, n=50) in the priming solution. Rapid thromboelastography (r-TEG) was measured before skin incision and 15 min after heparin neutralization. Postoperative renal and hepatic function, mediastinal chest tube drainage, transfusion requirements, and recovery time were observed. The relationships between hematologic and demographic data and postoperative bleeding volume were also analyzed. The results showed that there were significantly elevated levels of fibrinogen (r-TEG parameters: fibrinogen contribution to maximal amplitude (MAf) and fibrinogen level (FLEV)) in the FFP group compared to the GEL group. The postoperative blood loss, total transfusion requirements, and recovery time were not significantly different between the two groups, indicating that there were no obvious clinical benefits of using FFP in the priming. The maximal amplitude (MA) of r-TEG measured after heparin neutralization was correlated with the 6-h postoperative bleeding volume. In addition, preoperative fibrinogen level rather than FFP priming was an independent predictor of postoperative blood loss. CONCLUSION Prophylactic use of FFP in the priming solution does not have obvious clinical benefits in cyanotic congenital heart disease (CCHD) patients. Gelofusine, an artificial colloid, is a safe and effective substitute of FFP in the priming solution. Furthermore, r-TEG can be used as a "real-time" assessment tool to evaluate postoperative bleeding and guide transfusion after cardiac surgery in pediatric patients.
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Combination of acute preoperative plateletpheresis, cell salvage, and aprotinin minimizes blood loss and requirement during cardiac surgery
Li S, Ji H, Lin J, Lenehan E, Ji B, Liu J, Liu J, Long C, Crane TA
The Journal of Extra-Corporeal Technology. 2005;37((1):):9-14.
Abstract
Acute preoperative plateletpheresis (APP), cell salvage (CS) technique, and the use of aprotinin have been individually reported to be effective in reducing blood loss and blood component transfusion while improving hematological profiles in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). In this prospective randomized clinical study, the efficacy of these combined approaches on reducing blood loss and transfusion requirements was evaluated. Seventy patients undergoing primary coronary artery bypass grafting (CABG) were randomly divided into four groups: a control group (group I, n = 10) did not receive any of the previously mentioned approaches. An APP and CS group (group II, n = 20) experienced APP in which preoperative platelet-rich plasma was collected and reinfused after reversal of heparin, along with the cell salvage technique throughout surgery. The third group (group III, n = 22) received aprotinin in which 5,000,000 KIU Trasylol was applied during surgery, and a combination group (group IV, n = 18) was treated with all three approaches, i. e. , APP, CS, and aprotinin. Compared with group I (896+/-278 mL), the postoperative total blood loss was significantly reduced in groups II, III, and IV (468+/-136, 388+/-122, 202+/-81 mL, respectively, p < 0. 05). The requirements of packed red blood cells in the three approached groups (153+/-63, 105+/-178, 0+/-0 mL, respectively) also were reduced when compared with group I (343+/-118 mL, p < 0. 05). In group I, six patients (6/10) received fresh-frozen plasma and three patients (3/10) received platelet transfusion, whereas no patients in the other three groups required fresh-frozen plasma and platelet. In conclusion, both plateletpheresis concomitant with cell salvage and aprotinin contribute to the improvement of postoperative hemostasis, and the combination of these two approaches could minimize postoperative blood loss and requirement.