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

Vaginal Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921071
• Other study ID #: WOMC-22-0200
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Wolfson Medical Center
• Contact: Ohad Gluck
• Phone: 0528702255
• Email: ohadgluck[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Vaginal Hysterectomy

Intervention

Drug:
• Tranexamic acid
One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery
• Placebo
patients will receive 10 ml of normal saline 0.9% intravenously.

Locations

Country	Name	City	State
Israel	Wolfson medical center	H_olon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean objective assessment of blood loss	Objective assessment of blood loss is calculated by subtraction the weight of used pads after the surgery from the preoperative weight (blood lost during surgery will be absorbed by pads only, without using suction); 1 g of absorbed fluid will be converted to 1 mL of blood.	Immediately after surgery
Secondary	Mean subjective blood loss (SBL)	SBL will be estimated by the senior surgeon.	Immediately after surgery
Secondary	Mean difference in hemoglobin levels before and after surgery	Preoperative and postoperative hemoglobin level difference	One day after surgery
Secondary	The number of patients who need blood products transfusion	The need of blood transfusion or other blood products in order to treat excessive blood loss	30 days after surgery
Secondary	The size of pelvic hematoma after surgery	Postoperative pelvic hematoma, diagnosed and measured by ultrasound	One day after surgery