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

Do Patients Who Are Treated With Tranexamic Acid Loose Les Blood, Comparing to Patients Who Are Not Treated, During Vaginal Hysterectomy? a Randomized Control Study

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Hysterectomy
• Intervention / Treatment: Drug: Tranexamic acid; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ohad Gluck; Phone Number: 0528702255; Email: ohadgluck@gmail.com

Study Locations

• Israel
  • H̱olon, Israel
    • Recruiting
    • Wolfson Medical Center
    • Contact: Ohad Gluck, MD; Phone Number: 97235028329; Email: ohadgluck@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic acid arm; One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery.	Drug: Tranexamic acid; One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery; Other Names: Hexakapron
Placebo Comparator: Placebo arm; patients will receive 10 ml of normal saline 0.9% intravenously.	Drug: Placebo; patients will receive 10 ml of normal saline 0.9% intravenously.; Other Names: Normal Selaine 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean objective assessment of blood loss	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.	Immediately after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Principal Investigator: Ohad Gluck, Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: June 25, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: WOMC-22-0200

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No