Track topics on Twitter Track topics that are important to you
The objective of this study is to determine the effect of 1g of IV tranexamic acid given within 1 hour pre-operatively on intraoperative blood loss at time of hysterectomy.
Tranexamic acid (TXA) is a synthetic lysine analog that inhibits plasmin fibrinolysis. It may be administered orally, intravenously, or topically, with a rapid onset of action (tmax = appx 3 hours) and 11-hour half-life. It is 6 to 10 times more potent than aminocaproic acid, another commonly used synthetic antifibrinolytic agent. Typical IV dosing is 10 mg/kg followed by infusion of 1mg/kg/hour, or simply 1g intravenously in one dose.
The efficacy of tranexamic acid in control of hemorrhage in trauma patients has been reported extensively. The CRASH-2 trial collaborators randomized 20,211 adult trauma patients with significant bleeding or at risk of significant bleeding within 8 hours of injury to IV tranexamic acid or placebo. All-cause mortality was significantly reduced with tranexamic acid (RR .91; p = .0035). Additionally, risk of death due to bleeding was significantly lower in those receiving tranexamic acid (RR .85; p = .0077). No differences in risk of vascular occlusive events were noted. Further analysis revealed reduced risk of death from bleeding if TXA was given within 3 hours of injury; treatment administered after 3 hours from injury increased the risk of death due to bleeding.
Administration of TXA during elective surgery has also been investigated. A 2011 systematic review of 252 randomized trials of patients undergoing elective surgery across disciplines included administration of TXA, aminocaproic acid, and aprotinin. TXA administration reduced the risk of transfusion peri-operatively (RR .61). A 2012 meta-analysis of TXA use in both elective an emergency surgery revealed that TXA reduced the risk of transfusion by one-third. The effect of TXA on risk of myocardial infarction, deep vein thrombosis, and pulmonary embolism was not statistically significant.
The utility of TXA appears to extend to obstetric hemorrhage. Several published studies exist analyzing its use in prevention of postpartum hemorrhage, though the drug is not considered standard for prevention or treatment of this condition. A pilot randomized open-label trial of IV TXA in women with postpartum hemorrhage over 800cc reported a lower median blood loss between groups, though the effect was modest. Additionally, significantly fewer women in the TXA group required transfusion or invasive procedures. A recent Cochrane review reports on twelve trials of low risk women undergoing cesarean section or spontaneous birth who received uterotonics with or without the addition of TXA. TXA was effective in decreasing estimated blood loss over 1 liter in women undergoing cesarean section. Mean blood loss was significantly lower in women receiving TXA (mean difference -77.79mL); effect was similar for women undergoing cesarean section and vaginal birth. Finally, the WOMAN trial is a large, ongoing, placebo-controlled trial examining the effect of early TXA administration in clinically diagnosed postpartum hemorrhage.
The use of TXA in the management of acute and abnormal uterine bleeding has been reported, and is FDA-approved for treatment of menorrhagia. One randomized study of oral TXA in the treatment of ovulatory menorrhagia reported a 45% decrease in mean menstrual blood loss with use of TXA as compared with placebo20. Other studies have echoed these findings, with TXA more effective than NSAIDs but less effective than the levonorgestrel IUD in decreasing menstrual blood loss. More recently, a double-blind, placebo-controlled RCT confirmed a significant decrease in menstrual blood loss(mean -69cc), improvements in social/physical limitiations caused by menorrhagia and self-perceived menstrual blood loss. No data exist examining the efficacy of IV TXA in the management of acute or severe uterine bleeding.
Few studies have specifically examined the utility of prophylactic TXA in reducing mean blood loss during hysterectomy or other gynecologic procedures. In one study of patients undergoing endometrial ablation and endoscopic endometrial resection, intraoperative and postoperative IV TXA significantly decreased total blood loss. In patients undergoing major debulking surgery for gynecologic cancers, administration of IV TXA has been shown to decrease intra-operative blood loss by 30%. One well-designed study of women with advanced-stage ovarian cancer randomized patients to 15 mg/kg IV TXA or the same volume of placebo immediately before surgery. Outcomes included significantly lower mean estimated blood loss and decreased need for transfusion in the TXA group.
This study sought to determine whether a single preoperative dose of IV tranexamic acid effectively reduces intraoperative blood loss and need for transfusion in patients undergoing laparoscopic, abdominal, or vaginal hysterectomy for benign indications.
To determine the effect of 1g of IV tranexamic acid given within 1 hour pre-operatively on intraoperative blood loss at time of hysterectomy.
Estimated blood loss as determined by anesthesia and surgeon at time of hysterectomy, difference between post-operative and pre-operative hemoglobin, length of hospital stay, length of procedure, need for blood transfusion and post-operative venous thromboembolic events.
Treatment Dosage and Administration:
1g IV tranexamic acid or 10ml 0.9% sodium chloride solution administered within 1 hour of the start of the procedure
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Tranexamic Acid, Sodium Chloride
Not yet recruiting
Published on BioPortfolio: 2016-09-22T20:53:22-0400
This study is a prospective single-centre randomized trial to compare the effect of tranexamic acid versus placebo in the pre-hospital management of patients with moderate and severe traum...
In this study we will investigate whether tranexamic acid given as an intravenous bolus injection before start of surgery, followed by a continuous infusion during surgery reduces, periope...
Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac surgery and cardiopulmonary bypass. We have developed an assay for tranexamic acid. We have deve...
The purpose of this study is to evaluate the effect of 125 mg methylprednisolone, given intravenously 60-90 minutes before abdominal surgery,on the postoperative rehabilitation after abdom...
Fluid management of children during neurosurgery is not well established. Hypotonic solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse operative con...
Hysterectomy is one of the most frequently performed major gynecological surgical procedures. Even when the indication for the procedure is benign, relatively high complication rates have been reporte...
The aim of this randomized single-blind study is to compare taste and odor disturbances in patients receiving 0.9% sodium chloride flushes from 2 brands. Seventy-five patients from 6 to 18 years of ag...
Post-partum haemorrhage (PPH) is a major cause of maternal mortality globally. Tranexamic acid, an anti-fibrinolytic agent, is a novel approach in an attempt to prevent this dreadful complication. Thi...
Sodium-chloride solution-induced hyperhydration (NaCl-SolIH) is a powerful strategy to increase body water before exercise. However, NaCl-SolIH is associated with an unpleasant salty taste, potentiall...
To investigate the incidence rate of tranexamic acid (TXA)-associated seizures.
A subclass of symporters that specifically transport SODIUM CHLORIDE and POTASSIUM CHLORIDE across cellular membranes in a tightly coupled process.
Agents that inhibit SODIUM CHLORIDE SYMPORTERS. They act as DIURETICS. Excess use is associated with HYPOKALEMIA.
Sodium chloride used in foods.
Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.
Agents that inhibit SODIUM-POTASSIUM-CHLORIDE SYMPORTERS which are concentrated in the thick ascending limb at the junction of the LOOP OF HENLE and KIDNEY TUBULES, DISTAL. They act as DIURETICS. Excess use is associated with HYPOKALEMIA and HYPERGLYCEMIA.
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...