Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss

Not Applicable

• Conditions: Blood Loss
• Interventions: Other: IV 1 g normal saline; Drug: local tranexamic acid injection; Other: local normal saline injection to cervix; Drug: IV 1 g tranexamic acid

• Registration Number: NCT04760301
• Lead Sponsor: Meir Medical Center

Brief Summary

Assessing the efficiency of Prophylactic use of local tranexamic acid during vaginal hysterectomy to reduce blood loss during operation

Detailed Description

This randomized control trial will investigate whether local tranexamic acid is efficient for decreasing bleeding during vaginal hysterectomy.

The investigators will randomize local placebo (saline) vs. local 1 gr tranexamic acid; IV 1gr diluted in 100 ml saline and IV 100 ml saline at the beginning of surgery.

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02-16
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-18
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• 20-90 years old female patients going through vaginal hysterctomy

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Exclusion Criteria

• massive bleeding during operation due to major vessles injury
• known coagulopathies
• sensitivity to tranexamic acid
• medical need in tranexamic acid administration during operation due to bleeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IV 1 g normal saline	IV 1 g normal saline	100 ml saline- IV
local tranexamic acid injection to cervix	local tranexamic acid injection	1 gr of Tranexamic acid diluted in 10 ml saline
local normal saline injection to cervix	local normal saline injection to cervix	20 ml of saline
IV 1 g tranexamic acid	IV 1 g tranexamic acid	1 gr of Tranexamic acid diluted in 100 ml saline- IV

Primary Outcome Measures

Name	Time	Method
Blood loss during operation - measure in ml	End of surgery	At the end of the surgery, surgeon will measure the blood in the suction can

Trial Locations

Locations (2)

Meir Medical Center; 🇮🇱 Kfar Saba,, Israel

Meir medical center; 🇮🇱 Kfar Saba, Israel