Actively Recruiting
Local Tranexamic Acid During Vaginal Hysterectomy to Reduce Blood Loss
Led by Meir Medical Center · Updated on 2025-05-06
60
Participants Needed
2
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of local tranexamic acid to reduce blood loss during vaginal hysterectomy. This randomized controlled trial compares the effects of applying tranexamic acid directly to the cervix versus a placebo saline solution. The study aims to assess whether this treatment can decrease bleeding during the operation. Participants will be randomly assigned to receive either 1 gram of tranexamic acid diluted in 10 ml saline or 20 ml of saline alone, applied locally to the cervix at the start of surgery. This double-blind study ensures neither the participant nor the medical team knows which treatment is given during the procedure. During the operation, blood loss will be measured in milliliters as the primary outcome. The study involves monitoring bleeding during surgery to evaluate the treatment's impact. Participants will be followed through the surgery, with no additional long-term follow-up described. Total participation duration covers the surgical procedure and immediate blood loss assessment.
CONDITIONS
Brief Title
Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 20 to 90 years
- Scheduled for vaginal hysterectomy
You will not qualify if you...
- Massive bleeding during operation due to major vessel injury
- Known bleeding disorders or coagulopathies
- Sensitivity or allergy to tranexamic acid
- Medical need for tranexamic acid administration during operation due to bleeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo vaginal hysterectomy with either local tranexamic acid or saline injection to the cervix at the beginning of surgery to reduce blood loss.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Meir Medical Center
Kfar Saba, Israel, Israel, 11125
Not Yet Recruiting
2
Meir medical center
Kfar Saba, Israel
Actively Recruiting
Research Team
Y
Yair Daykan, M.D
G
Gal Cohen, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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