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

Wolfson Medical Center (WMC)

Status: Enrolling

Conditions: Vaginal Hysterectomy

Treatments: Drug: Tranexamic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05921071

WOMC-22-0200

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Tranexamic acid arm

Active Comparator group

Description:

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

Treatment:

Drug: Tranexamic acid

Placebo arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo