Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy

March 5, 2024 updated by: Warda Demerdash Khalifa Ali, Al-Azhar University

Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy: A Randomized Clinical Study

To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.

Interventions Study interventions Patients in all groups will receive identically looking pharmaceutical preparations which differ according to the study group

  1. Vasopressin group Just before beginning of AH, patients in this group will be injected with a 10-ml syringe containing 10 units of VP (5 mL bilaterally), 1 cm medial to the uterine vessels in the most distal area of the lower uterine segment not to compromise the bladder. If this site is not accessible, patients will be alternatively injected in the midline at the fundus (Okin et al., 2001). In addition, and just before closure of peritoneum, 100 ml of normal saline (NS) will be applied topically over the raw surface.
  2. Tranexamic acid group Just before AH, patients in this group will be injected with a 10-ml syringe containing 10 ml of NS (5 mL bilaterally) as described above. Just before closure of peritoneum, 1.5 g of TXA mixed in 100 ml of NS will be applied topically over the raw surface (Mitra et al., 2022).
  3. Control group Just before AH, patients in this group will be injected with a 10-ml syringe containing 10 ml of NS (5 mL bilaterally) as described above. In addition, and just before closure of peritoneum, 100 ml of normal saline (NS) will be applied topically over the raw surface.

Study Type

Interventional

Enrollment (Estimated)

387

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Patients will be included in the present study if they are indicated for abdominal hysterectomy for benign lesions.

Exclusion Criteria:

  • history of coagulation or bleeding disorders or
  • if they were under antithrombotic treatment.
  • associated malignancy, renal impairment or allergy to TA.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vasopressin group
patients in this group will be injected with a 10-ml syringe containing 10 units of vasopressin (5 mL bilaterally)
Drug: Vasopressin
Hemostatic drug.
Experimental: Tranexamic acid group
patients in this group will be injected with a 10-ml syringe containing 10 ml of tranexamic acid (5 mL bilaterally).
Drug: Tranexamic acid
Hemostatic drug.
Placebo Comparator: Control group
patients in this group will be injected with a 10-ml syringe containing 10 ml of normal saline (5 mL bilaterally).
Other: Saline
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss
Time Frame: 24 hours
Amount of blood loss in mL
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSR/AZAST/AIP029/21/222/8/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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