Do Patients Who Received Tranexamic Acid in Vaginal Hysterectomy Loose Les Blood, Comparing to Patients Who Did Not?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-22

Study Completion Date

2025-01-01

Brief Summary

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This is a randomized control, double-blind study in which women who are about to go an elective vaginal hysterectomy are offered to participate.

Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.

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Detailed Description

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This is a randomized control, double-blind study in which women who are about to go for an elective vaginal hysterectomy are offered to participate.

Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.

A nurse will prepare the solution according to the randomization and will handle it to the anesthesiologist.

Conditions

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Vaginal Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Tranexamic acid arm

One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery.

Group Type ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type DRUG

One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery

Placebo arm

patients will receive 10 ml of normal saline 0.9% intravenously.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

patients will receive 10 ml of normal saline 0.9% intravenously.

Interventions

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Tranexamic acid

One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery

Intervention Type DRUG

Placebo

patients will receive 10 ml of normal saline 0.9% intravenously.

Intervention Type DRUG

Other Intervention Names

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Hexakapron Normal Selaine 0.9%

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes