Comparing blood loss in vaginal hysterectomy with and without tranexamic acid
Do Patients Who Are Treated With Tranexamic Acid Loose Les Blood, Comparing to Patients Who Are Not Treated, During Vaginal Hysterectomy? a Randomized Control Study
This study is testing if giving women tranexamic acid before a vaginal hysterectomy can help reduce blood loss during the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Sex | Female |
| Sponsor | Wolfson Medical Center Government |
| Locations | 1 site (H̱olon) |
| Trial ID | NCT05921071 on ClinicalTrials.gov |
What this trial studies
This randomized control, double-blind study evaluates the effect of tranexamic acid on blood loss during elective vaginal hysterectomy. Women scheduled for the procedure will be randomly assigned to receive either 1 gram of tranexamic acid or a placebo (normal saline) intravenously before surgery. The study aims to determine if tranexamic acid can significantly reduce blood loss compared to the control group. A nurse will prepare the solutions based on randomization, ensuring the anesthesiologist is unaware of the treatment assignment.
Who should consider this trial
Good fit: Ideal candidates are women in good health who are scheduled for elective vaginal hysterectomy due to pelvic organ prolapse.
Not a fit: Patients with a history of hypercoagulability disorders, renal impairment, or those receiving antithrombotic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced blood loss during vaginal hysterectomy, improving patient outcomes and recovery times.
How similar studies have performed: Previous studies have shown that tranexamic acid can effectively reduce blood loss in various surgical procedures, suggesting potential success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \*Women in general good health (defined as American Society of Anesthesiologists grade 1-2) who are about to undergo elective vaginal hysterectomy indicated by pelvic organ prolapse (POP). Exclusion Criteria: * allergy to TXA * familial or personal history of hypercoagulability disorder or thromboembolic events * impaired renal function or hematuria * patients receiving antithrombotic therapy * additional concurrent abdominal/ laparoscopic procedures * malignancy * Post-assignment exclusion will be executed in cases of conversion to laparotomy/ laparoscopy.
Where this trial is running
H̱olon
- Wolfson medical center — H̱olon, Israel (Recruiting)
Study contacts
- Principal investigator: Ohad Gluck — Wolfson Medical Center
- Study coordinator: Ohad Gluck
- Email: ohadgluck@gmail.com
- Phone: 0528702255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.