"The Efficacy of Prophylactic Tranexamic   Acid in Reducing Perioperative Blood Loss  During Caesarean Section: A Randomized, Double  Blind Control Trial"

Objectives: Tranexamic acid (TXA) is a commonly used medication in orthopaedic procedures, reducing perioperative bleeding and need for transfusion. The purpose of this double-blind randomized controlled study was to evaluate if IV TXA for primary anterior cruciate ligament (ACL) reconstruction with bone-patella tendon-bone (BTB) could reduce perioperative blood loss or postoperative intra-articular hemarthrosis without postoperative drains. Methods: A controlled, randomized, double-blinded trial was conducted in 110 patients who underwent ACLR with BTB autograft. Patients were equally randomized to the control and experimental groups. The experimental group received two 1-gram boluses of IV TXA, one prior to tourniquet inflation and one prior to wound closure; the control group did not receive TXA. If a clinically significant hemarthrosis was evident, the knee was aspirated, and the volume of blood (ml) was recorded. Additionally, perioperative blood loss (ml); Visual Analog Scale (VAS) on postoperative days (POD) 1-7 and post-operative weeks (POW) 1, 6 and 12; postoperative opioid consumption POD 1-7; range of motion (ROM) and ability to straight leg raise (SLR) at POW 1, 6, 12; and pre and postoperative thigh circumference ratio (TCR). Results: There was no significant difference in perioperative blood loss between the experimental and control groups (32.5ml v. 35.6ml, p=0.47). The experimental group had 23 knees aspirated; control group had 26 knees aspirated (p=0.56). No significant difference seen in postoperative hemarthrosis volume with IV TXA (26.7ml v. 37.3ml, p=0.12). There was no significant difference in VAS score between the two groups (p=0.15), additionally, there was no difference in postoperative opioid consumption (p=0.33). There was no significant difference in ROM or ability to SLR, or pre- nor post-operative TCR (p > 0.05 for all). Conclusions: IV TXA in patients who undergo ACLR with BTB autograft does not significantly impact perioperative blood loss, postoperative hemarthrosis, or postoperative pain levels. Additionally, no significant differences were seen in early post-operative recovery regarding ROM or quadriceps reactivation.

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Effect of Tranexamic Acid Irrigation on Perioperative Blood Loss During Orthognathic Surgery: A Double-Blind, Randomized Controlled Clinical Trial

Journal of Oral and Maxillofacial Surgery ◽

10.1016/j.joms.2014.07.033 ◽

2015 ◽

Vol 73 (1) ◽

pp. 129-133 ◽

Cited By ~ 19

Author(s):

Hamidreza Eftekharian ◽

Ruhollah Vahedi ◽

Tuba Karagah ◽

Reza Tabrizi

Keyword(s):

Clinical Trial ◽

Blood Loss ◽

Tranexamic Acid ◽

Orthognathic Surgery ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Double Blind ◽

Randomized Controlled ◽

Perioperative Blood Loss ◽

Acid Irrigation

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Efficacy of Tranexamic Acid in Pediatric Craniosynostosis Surgery

Anesthesiology ◽

10.1097/aln.0b013e318210fd8f ◽

2011 ◽

Vol 114 (4) ◽

pp. 862-871 ◽

Cited By ~ 169

Author(s):

Susan M. Goobie ◽

Petra M. Meier ◽

Luis M. Pereira ◽

Francis X. McGowan ◽

Randy P. Prescilla ◽

...

Keyword(s):

Blood Transfusion ◽

Blood Loss ◽

Tranexamic Acid ◽

Plasma Concentrations ◽

Secondary Outcome ◽

Double Blind ◽

Total Blood ◽

Reconstruction Surgery ◽

Perioperative Blood Loss ◽

The Difference

Background Extensive blood loss is common in pediatric craniosynostosis reconstruction surgery. Tranexamic acid (TXA) is increasingly used to reduce perioperative blood loss in various settings, but data on its efficacy are limited in children. The purpose of this randomized, double-blind, placebo-controlled, parallel trial was to evaluate the efficacy of TXA in pediatric craniosynostosis correction surgery. The primary and secondary outcome variables were reduction in perioperative blood loss and reduction in blood transfusion, respectively. Methods Forty-three children, ages 2 months to 6 yr, received either placebo or TXA in a loading dose of 50 mg·kg(-1), followed by an infusion of 5 mg·kg·h(-1) during surgery. TXA plasma concentrations were measured. Results The TXA group had significantly lower perioperative mean blood loss (65 vs. 119 ml·kg(-1), P < 0.001) and lower perioperative mean blood transfusion (33 vs. 56 ml· kg(-1), P = 0.006) compared to the placebo group. The mean difference between the TXA and placebo groups for total blood loss was 54 ml·kg(-1) (95% CI for the difference, 23-84 ml·kg(-1)) and for packed erythrocytes transfused was 23 ml·kg(-1) (95% CI for the difference, 7-39 ml·kg(-1)). TXA administration also significantly diminished (by two thirds) the perioperative exposure of patients to transfused blood (median, 1 unit vs. 3 units; P < 0.001). TXA plasma concentrations were maintained above the in vitro thresholds reported for inhibition of fibrinolysis (10 μg·ml(-1)) and plasmin-induced platelet activation (16 μg·ml(-1)) throughout the infusion. Conclusions TXA is effective in reducing perioperative blood loss and transfusion requirement in children undergoing craniosynostosis reconstruction surgery.

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Is low dose Tranexamic acid less effective than a standard dose at reducing blood loss and inhibiting hyperfibrinolysis in hemorrhagic caesarean section? Multicenter double–blind placebo-controlled dose-ranging (TRACES) trial.

10.22541/au.163584601.19864996/v1 ◽

2021 ◽

Author(s):

Anne-Sophie Ducloy-Bouthors ◽

Sixtine Gilliot ◽

Maeva Kyheng ◽

David Faraoni ◽

Alexandre Turbelin ◽

...

Keyword(s):

Caesarean Section ◽

Blood Loss ◽

Tranexamic Acid ◽

Standard Dose ◽

Study Drug ◽

Double Blind ◽

Simultaneous Generation ◽

Pharmacodynamic Modelling ◽

Dose Ranging ◽

To Receive

Objective: To study the effect of a low (0.5g) or a standard (1g) tranexamic acid (TA) dose compared to placebo on clinical and biological endpoints in women experiencing postpartum hemorrhage (PPH) Design: TRACES trial is a double-blind, randomized, placebo-controlled, dose-ranging study Setting: 8 women hospitals in France. Population: Women experiencing PPH > 800 mL during caesarean section. Method: After informed consent, patients were randomized to receive either TA 0.5g (n=57), TA 1g (n=58), or a placebo (n=60). Data were collected at 8 time-points. Main outcome measures: Efficacy: additional blood loss after study drug, maternal morbidity, safety, biology: D-dimers, plasmin-antiplasmin complexes (PAP), simultaneous-generation-thrombin-plasmin-potential. Results: Compared to 1g dose, 0.5g TA was less effective to reduce additional blood loss (300 mL [95% confidence interval (95%CI) 68 to 630] vs 134 mL [95%CI50 to 419] (p=0.042)). Compared to placebo, 1g TA, but not 0.5g, inhibited hyperfibrinolysis as shown by plasmin generation potential, % increase in D-dimers from injection to 120 minutes (93% [95%CI 68 to 118] vs 58% [ 95%CI 32 to 84] (p=0.06) vs 38% [95%CI 13 to 63] (p=0.003) and % increase in PAP from injection to 30 minutes (56% [95%CI 25 to 87] vs 13% [ 95%CI 18 to 43] (p=0,051) vs -2% [95%CI -32 to 28] (p=0.009)). Conclusions: In this study, fibrinolysis inhibition was more sustained after the administration of 1g TA compared to 0.5g TA or a placebo. Further pharmacokinetic-pharmacodynamic modelling will be needed to determine the optimal TA dose to be administered in PPH. NCT 02797119

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

Journal of Neurosurgery Spine ◽

10.3171/2019.1.spine1814 ◽

2019 ◽

Vol 31 (2) ◽

pp. 194-200 ◽

Cited By ~ 1

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)

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