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

NCT06290596 | Not Yet Recruiting Phase 4

• 1 other identifier: MSR/AZAST/AIP029/21/222/8/2023
• Study Type: interventional
• Target: 387
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Uterine Surgery

Outcome Measures

Primary Outcomes (1)

• blood loss

  Amount of blood loss in mL

  24 hours

Study Arms (3)

Vasopressin group

EXPERIMENTAL

patients in this group will be injected with a 10-ml syringe containing 10 units of vasopressin (5 mL bilaterally)

Drug: Vasopressin

Tranexamic acid group

EXPERIMENTAL

patients in this group will be injected with a 10-ml syringe containing 10 ml of tranexamic acid (5 mL bilaterally).

Drug: Tranexamic acid

Control group

PLACEBO COMPARATOR

patients in this group will be injected with a 10-ml syringe containing 10 ml of normal saline (5 mL bilaterally).

Other: Saline

Interventions

Vasopressin DRUG

Hemostatic drug.

Vasopressin group

Tranexamic acid DRUG

Hemostatic drug.

Tranexamic acid group

Saline OTHER

Placebo

Control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Interventions

Vasopressins; Tranexamic Acid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 4, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share