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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06290596
Enrollment
387
Registered
2024-03-04
Start date
2024-04-01
Completion date
2024-10-01
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Surgery

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.

Interventions

DRUGVasopressin

Hemostatic drug.

DRUGTranexamic acid

Hemostatic drug.

OTHERSaline

Placebo

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
blood loss24 hoursAmount of blood loss in mL

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026