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

Al-Azhar University

Status and phase: Not yet enrolling; Phase 4

Conditions: Uterine Surgery

Treatments: Drug: Vasopressin; Other: Saline; Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06290596

MSR/AZAST/AIP029/21/222/8/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 387 estimated patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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387 participants in 3 patient groups, including a placebo group

Vasopressin group

Experimental group

Description:

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

Treatment:

Drug: Vasopressin

Tranexamic acid group

Experimental group

Description:

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

Treatment:

Drug: Tranexamic acid

Control group

Placebo Comparator group

Description:

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

Treatment:

Other: Saline