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

Phase 4

Not yet recruiting

• Conditions: Uterine Surgery
• Interventions: Other: Saline; Drug: Vasopressin; Drug: Tranexamic acid

• Registration Number: NCT06290596
• Lead Sponsor: Al-Azhar University

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.

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 Timeline

• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-02-27
• Status Verified: 2024-03
• Study First Posted: 2024-03-04
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Study Start: 2024-04-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 387

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Saline	patients in this group will be injected with a 10-ml syringe containing 10 ml of normal saline (5 mL bilaterally).
Vasopressin group	Vasopressin	patients in this group will be injected with a 10-ml syringe containing 10 units of vasopressin (5 mL bilaterally)
Tranexamic acid group	Tranexamic acid	patients in this group will be injected with a 10-ml syringe containing 10 ml of tranexamic acid (5 mL bilaterally).

Primary Outcome Measures

Name	Time	Method
blood loss	24 hours	Amount of blood loss in mL