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NCT04760301 Clinical Trial

Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss

Blood Loss Clinical Trial

Official title:
Local Tranexamic Acid During Vaginal Hysterectomy to Reduce Blood Loss

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04760301
Other study ID # 0354-19-MMC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 16, 2021
Est. completion date January 2022

Study information
Verified date February 2021
Source Meir Medical Center
Contact Yair Daykan, M.D
Phone 0542198231
Email yair.dykan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date January 2022
Est. primary completion date January 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria: - 20-90 years old female patients going through vaginal hysterctomy 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• local tranexamic acid injection
local tranexamic acid injection to cervix- 1 g tranexamic acid diluted in 10 ml saline
Other:
• local normal saline injection to cervix
local normal saline injection to the cervix- 20 ml saline
Drug:
• IV 1 g tranexamic acid
IV 1 g tranexamic acid diluted in 100 ml saline
Other:
• IV 1 g normal saline
IV 100 ml normal saline

Locations
Country Name City State
Israel Meir medical center Kfar Saba
Israel Meir Medical Center Kfar Saba,

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood loss during operation - measure in ml At the end of the surgery, surgeon will measure the blood in the suction can End of surgery
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