scholarly journals Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040914
Author(s):  
Kenta Ishii ◽  
Yukihiro Yokoyama ◽  
Yoshihiko Yonekawa ◽  
Tomoki Ebata
Keyword(s):  
Placebo Group ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Operation Time ◽  
Skin Incision ◽  
Research Review ◽  
Registration Number ◽  
Poor Outcomes

IntroductionPancreaticoduodenectomy (PD) is a major gastroenterological surgery that results in a substantial amount of blood loss. Several studies have demonstrated that major blood loss during PD is associated with both short-term and long-term poor outcomes. Administration of perioperative tranexamic acid (TXA) has been reported to reduce intraoperative blood loss in various surgeries, including cardiovascular surgery and orthopaedic surgery. Nevertheless, the effect of perioperative TXA use in patients undergoing PD has not been investigated. This study aims to investigate the effect of TXA on blood loss during PD.Methods and analysisA multicentre (six hospitals), randomised, blind (patient-blinded, surgeon-blinded, anaesthesiologist-blinded, monitor-blinded), placebo-controlled trial of TXA during PD was started in September 2019. Patients undergoing PD for biliary, duodenal or pancreatic diseases are randomly assigned to the TXA or placebo group. The stratification factors are the institutions and preoperative clinical diagnosis. Before skin incision, the participants in TXA group are administrated 1 g TXA as a loading infusion followed by a maintenance infusion of 125 mg/hour TXA until the end of surgery or 8 hours from the incision. Participants in the placebo group are administrated the same volume of saline that is indistinguishable from the TXA. The primary outcome is blood loss during PD. The secondary outcomes are intraoperative and postoperative (up to day 2) blood transfusions, operation time, anaesthesia time, postoperative laboratory variables, length of hospital stay, in-hospital and 90-day mortality and postoperative complications occurring within 28 days of surgery or requiring readmission. To date, 115 patients of a planned 220 have been enrolled in the study.Ethics and disseminationThis protocol was approved by the Nagoya University Clinical Research Review Board and is registered with Japan Registry of Clinical Trials on 15 August 2019. The results of this trial will be disseminated through peer-reviewed journals.Trial registration numberjRCTs041190062.

scholarly journals Comparison between epsilon-aminocaproic acid and tranexamic acid for total hip and knee arthroplasty: A meta-analysis

2020 ◽  
Vol 28 (3) ◽  
pp. 230949902095915
Author(s):  
Wen-bin Liu ◽  
Gui-Shi Li ◽  
Peng Shen ◽  
Fu-jiang Zhang
Keyword(s):  
Blood Transfusion ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Meta Analysis ◽  
Length Of Hospital Stay ◽  
Operation Time ◽  
Aminocaproic Acid ◽  
Transfusion Rate ◽  
Discharge Operation ◽  
Epsilon Aminocaproic Acid

Background: The aim was to compare the efficacy and safety of epsilon-aminocaproic acid (EACA) and tranexamic acid (TXA) in total hip arthroplasty (THA) and total knee arthroplasty (TKA). Methods: Potential academic articles were identified from the Cochrane Library, Springer, PubMed, and ScienceDirect databases from inception to December 2019. Randomized controlled trials (RCTs) and non-RCTs involving EACA and TXA in THA or TKA were included. Pooled data were analyzed using RevMan 5.1. Results: Three RCTs and three non-RCTs met the inclusion criteria. The present meta-analysis reveals that EACA is associated with significantly more blood loss than TXA. No significant differences were identified in terms of blood transfusion rate, transfusion units, hemoglobin (Hb) level at discharge, operation time, length of hospital stay, deep venous thrombosis (DVT), or 30-day readmission. Conclusions: Compared with TXA, EACA led to more blood loss in patients undergoing THA or TKA. However, there was no significant difference in the blood transfusion rate, transfusion units, Hb level at discharge, operation time, length of hospital stay, DVT, or 30-day readmission between groups.

Double-blind, randomized controlled trial of tranexamic acid in minor lumbar spine surgery: no effect on operative time, intraoperative blood loss, or complications

2019 ◽  
Vol 31 (2) ◽  
pp. 194-200 ◽  
Author(s):  
Signe Elmose ◽  
Mikkel Ø. Andersen ◽  
Else Bay Andresen ◽  
Leah Yacat Carreon
Keyword(s):  
Placebo Group ◽  
Lumbar Spine ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Spine Surgery ◽  
Operative Time ◽  
Decompressive Surgery ◽  
Lumbar Spine Surgery ◽  
Intraoperative Blood Loss ◽  
Double Blind

OBJECTIVEThe purpose of this study was to investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery—specifically with respect to operative time, estimated blood loss, and complications. Studies have shown that TXA reduces blood loss during major spine surgery. There have been no previous studies on the effect of TXA in minor lumbar spine surgery in which these variables have been evaluated.METHODSThe authors enrolled patients with ASA grades 1 to 2 scheduled to undergo lumbar decompressive surgery at Middelfart Hospital into a double-blind, randomized, placebo-controlled, parallel-group study. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA, or a history of convulsion were excluded. Patients were randomly assigned, in blocks of 10, to one of 2 groups, TXA or placebo. Anticoagulation therapy was discontinued 2–7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10 mg/kg) or an equivalent volume of saline solution (placebo). Independent t-tests were used to compare differences between the 2 groups, with statistical significance set at p < 0.05.RESULTSOf the 250 patients enrolled, 17 patients were excluded, leaving 233 cases for analysis (117 in the TXA group and 116 in the placebo group). The demographics of the 2 groups were similar, except for a higher proportion of women in the TXA group (TXA 50% vs placebo 32%, p = 0.017). There was no significant between-groups difference in operative time (49.53 ± 18.26 vs 54.74 ± 24.49 minutes for TXA and placebo, respectively; p = 0.108) or intraoperative blood loss (55.87 ± 48.48 vs 69.14 ± 83.47 ml for TXA and placebo, respectively; p = 0.702). Postoperative blood loss measured from drain output was 62% significantly lower in the TXA group (13.03 ± 21.82 ml) than in the placebo group (34.61 ± 44.38 ml) (p < 0.001). There was no significant difference in number of dural lesions or postoperative spinal epidural hematomas, and there were no thromboembolic events.CONCLUSIONSTranexamic acid did not have a statistically significant effect on operative time, intraoperative blood loss, or complications. This study gives no evidence to support the routine use of TXA during minor lumbar decompressive surgery.Clinical trial registration no.: NCT03714360 (clinicaltrials.gov)

scholarly journals Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial

2021 ◽  
pp. svn-2021-000942
Author(s):  
Jingyi Liu ◽  
Ximing Nie ◽  
Hongqiu Gu ◽  
Qi Zhou ◽  
Haixin Sun ◽  
...  
Keyword(s):  
Placebo Group ◽  
Tranexamic Acid ◽  
Intracerebral Haemorrhage ◽  
Intracranial Haemorrhage ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intracerebral Haematoma ◽  
Spot Sign ◽  
Double Blind ◽  
Risk Of Death

BackgroundStudies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in intracerebral haemorrhage patients susceptible to haemorrhage expansion.MethodsWe did a prospective, double-blind, randomised, placebo-controlled trial at 10 stroke centres in China. Acute supratentorial intracerebral haemorrhage patients were eligible if they had indication of haemorrhage expansion on admission imaging (eg, spot sign, black hole sign or blend sign), and were treatable within 8 hours of symptom onset. Patients were randomly assigned (1:1) to receive either tranexamic acid or a matching placebo. The primary outcome was intracerebral haematoma growth (>33% relative or >6 mL absolute) at 24 hours. Clinical outcomes were assessed at 90 days.ResultsOf the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. 89 patients received tranexamic acid and 82 received placebo. The primary outcome did not differ significantly between the groups: 36 (40.4%) patients in the tranexamic acid group and 34 (41.5%) patients in the placebo group had intracranial haemorrhage growth (OR 0.96, 95% CI 0.52 to 1.77, p=0.89). The proportion of death was lower in the tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracranial haemorrhage growth, death and dependency.ConclusionsAmong patients susceptible to haemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral haemorrhage growth. Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral haemorrhage patients.

scholarly journals Efficacy and Safety of Tranexamic Acid in Bimaxillary Orthognathic Surgery

2020 ◽  
Vol 28 (2) ◽  
pp. 94-104
Author(s):  
Liang Sun ◽  
Rui Guo ◽  
Yi Feng
Keyword(s):  
Blood Transfusion ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Orthognathic Surgery ◽  
Operation Time ◽  
Controlled Trials ◽  
Allogenic Blood Transfusion ◽  
Intraoperative Blood Loss ◽  
Irrigation Fluid ◽  
Allogenic Blood

Background: Tranexamic acid (TXA) has been widely used during craniofacial and orthognathic surgery (OS). However, results of the literature are inconsistent due to specific type of surgery and a small sample of studies. The purpose of this study was to evaluate the role of TXA in bimaxillary OS. Methods: We performed a comprehensive literature search of PubMed, Cochrane Central Register of Controlled Trials, and EMBASE to identify randomized controlled trials (RCTs) that compared effect of TXA on bimaxillary OS with placebo. Outcomes of interests included intraoperative blood loss, allogenic transfusion, operation time, and volume of irrigation fluid. Random effects models were chosen considering that heterogeneity between studies was anticipated, and I 2 statistics were used to test for the presence of heterogeneity. Results: Totally 6 RCTs were identified. Tranexamic acid resulted in significantly reduced intraoperative blood loss (weighted mean difference [WMD] = −264.82 mL; 95% CI: −380.60 to −149.04 mL) and decreased amounts of irrigation fluid (WMD = −229.23 mL; 95% CI: −399.63 to −58.83 mL). However, TXA had no remarkable impact on risk of allogenic blood transfusion (pooled risk ratio = 0.50; 95% CI: 0.20-1.23), operation time (WMD = −8.71 min; 95% CI: −20.98 to 3.57 min), and length of hospital stay (WMD = −0.24 day; 95% CI: −0.62 to 0.14 day). No TXA-associated severe adverse reactions or complications were observed. Conclusions: Currently available meta-analysis reveals that TXA is effective in decreasing intraoperative blood loss; however, it does not reduce the risk of allogenic blood transfusion in bimaxillary OS.

Intra-Articular Tranexamic Acid Mitigates Blood Loss and Morphine Use After Total Knee Arthroplasty. A Randomized Controlled Trial

2019 ◽  
Vol 34 (5) ◽  
pp. 877-881 ◽  
Author(s):  
Artit Laoruengthana ◽  
Piti Rattanaprichavej ◽  
Supachok Rasamimongkol ◽  
Monton Galassi ◽  
Santi Weerakul ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Total Knee

scholarly journals Efficacy of tranexamic acid in reducing blood loss, blood and blood products requirements in Cesarian sections for patients with placenta accreta

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Tamer Hamed Ibrahim
Keyword(s):  
Platelet Count ◽  
Placebo Group ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Placenta Accreta ◽  
Controlled Study ◽  
Intraoperative Blood Loss ◽  
Blood Products ◽  
Coagulation Profile ◽  
Significant Difference

Abstract Background Placenta accreta is an obstetric emergency and the main cause of maternal morbidity and mortality due to the associated bleeding and coagulopathy. Tranexamic acid has been widely used to decrease blood loss in trauma patients and patients with postpartum hemorrhage. We aimed at studying the effect of tranexamic acid in reducing blood loss and blood transfusion in patients with placenta accreta. Methods In a double-blinded randomized controlled study, 46 patients were recruited and divided into two groups, Group A is the tranexamic group where patients received 10 mg/kg tranexamic acid after cord clamping and continued on tranexamic infusion 10 mg/kg/h till the end of the surgery. Group B is the placebo where patients received normal saline instead. Primary outcome was the amount of intraoperative blood loss, and other outcomes included the number of blood and blood products transfused intraoperative and in the first 24 h postoperative, the immediate postoperative Hb level, platelet count, and coagulation profile. Data were collected, coded, tabulated, and then analyzed using Minitab® 16.1.0 statistics software package. Variables were presented as mean and standard deviation and analyzed using unpaired t test. Any difference with p value < 0.05 was considered statistically significant. Results Amount of intraoperative blood loss was significantly less in the tranexamic group 2232 ± 1204 ml compared to the placebo group 3405 ± 1193 ml (p value 0.002), and patients in the tranexamic group received less units of packed red blood cells, fresh frozen plasma, and platelets compared to those in the placebo group (4.2 ± 1.9 vs 6.1 ± 2.2 with p value 0.003, 3.4 ± 1.3 vs 4.2 ± 1.2 with P value 0.036 and 4.8 ± 2.1 vs 6.2 ± 2.4 with p value 0.041, respectively). There was no statistically significant difference in the first postoperative Hb level, platelet count, and coagulation profile between the two groups; however, the amount of blood and products transfused in the first 24 h postoperative were significantly less in the tranexamic group Conclusion Tranexamic acid infusion was effective in reducing intraoperative blood loss and intraoperative and postoperative blood and blood products’ transfusion.

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