Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss

Clalit Health Services

Status: Enrolling

Conditions: Blood Loss

Treatments: Drug: local tranexamic acid injection; Other: local normal saline injection to cervix

Study type: Interventional

Funder types: Other

Identifiers

NCT04760301

0354-19-MMC

Details and patient eligibility

About

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

Full 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; local 1gr tranexamic acid diluted in 10 ml saline and local 10 ml saline at the beginning of surgery.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

local tranexamic acid injection to cervix

Experimental group

Description:

1 gr of Tranexamic acid diluted in 10 ml saline

Treatment:

Drug: local tranexamic acid injection

local normal saline injection to cervix

Placebo Comparator group

Description:

20 ml of saline

Treatment:

Other: local normal saline injection to cervix