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

NCT05921071 | Recruiting DMC

• 1 other identifier: WOMC-22-0200
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mean subjective blood loss (SBL)

  Immediately after surgery

• Mean difference in hemoglobin levels before and after surgery

  One day after surgery

• The number of patients who need blood products transfusion

  30 days after surgery

• The size of pelvic hematoma after surgery

  One day after surgery

Study Arms (2)

Tranexamic acid arm

ACTIVE COMPARATOR

One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery.

Drug: Tranexamic acid

Placebo arm

PLACEBO COMPARATOR

patients will receive 10 ml of normal saline 0.9% intravenously.

Drug: Placebo

Interventions

Tranexamic acid DRUG

One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery

Also known as: Hexakapron

Tranexamic acid arm

Placebo DRUG

patients will receive 10 ml of normal saline 0.9% intravenously.

Also known as: Normal Selaine 0.9%

Placebo arm

Eligibility Criteria

• Gender Eligibility Details: only women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \*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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson medical center

Holon, Israel

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ohad Gluck

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ohad Gluck

CONTACT

0528702255; ohadgluck@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior gynecologist, Principal Investigator, Associated Professor

Model Details: Randomized control

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: June 27, 2023
• Study Start: January 22, 2023
• Primary Completion: June 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

IL (1)