Do Patients Who Received Tranexamic Acid in Vaginal Hysterectomy Loose Les Blood, Comparing to Patients Who Did Not?

Not Applicable

Recruiting

• Conditions: Vaginal Hysterectomy
• Interventions: Drug: Tranexamic acid; Drug: Placebo

• Registration Number: NCT05921071
• Lead Sponsor: Wolfson Medical Center

Brief Summary

This is a randomized control, double-blind study in which women who are about to go an elective vaginal hysterectomy are offered to participate.

Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.

Detailed Description

This is a randomized control, double-blind study in which women who are about to go for an elective vaginal hysterectomy are offered to participate.

Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.

A nurse will prepare the solution according to the randomization and will handle it to the anesthesiologist.

Study Timeline

• Study Start: 2023-01-22
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-06-25
• Study First Posted: 2023-06-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-06-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

*Women in general good health (defined as American Society of Anesthesiologists grade 1-2) who are about to undergo elective vaginal hysterectomy indicated by pelvic organ prolapse (POP).

Exclusion Criteria

• allergy to TXA
• familial or personal history of hypercoagulability disorder or thromboembolic events
• impaired renal function or hematuria
• patients receiving antithrombotic therapy
• additional concurrent abdominal/ laparoscopic procedures
• malignancy
• Post-assignment exclusion will be executed in cases of conversion to laparotomy/ laparoscopy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid arm	Tranexamic acid	One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery.
Placebo arm	Placebo	patients will receive 10 ml of normal saline 0.9% intravenously.

Primary Outcome Measures

Name	Time	Method
Mean objective assessment of blood loss	Immediately after surgery	Objective assessment of blood loss is calculated by subtraction the weight of used pads after the surgery from the preoperative weight (blood lost during surgery will be absorbed by pads only, without using suction); 1 g of absorbed fluid will be converted to 1 mL of blood.

Secondary Outcome Measures

Name	Time	Method
Mean subjective blood loss (SBL)	Immediately after surgery	SBL will be estimated by the senior surgeon.
Mean difference in hemoglobin levels before and after surgery	One day after surgery	Preoperative and postoperative hemoglobin level difference
The number of patients who need blood products transfusion	30 days after surgery	The need of blood transfusion or other blood products in order to treat excessive blood loss
The size of pelvic hematoma after surgery	One day after surgery	Postoperative pelvic hematoma, diagnosed and measured by ultrasound

Trial Locations

Locations (1)

Wolfson medical center; 🇮🇱 H̱olon, Israel