Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss

NCT ID: NCT04760301

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-16

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

local tranexamic acid injection to cervix

1 gr of Tranexamic acid diluted in 10 ml saline

Group Type EXPERIMENTAL

local tranexamic acid injection

Intervention Type DRUG

local tranexamic acid injection to cervix- 1 g tranexamic acid diluted in 10 ml saline

local normal saline injection to cervix

20 ml of saline

Group Type PLACEBO_COMPARATOR

local normal saline injection to cervix

Intervention Type OTHER

local normal saline injection to the cervix- 20 ml saline

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

local tranexamic acid injection

local tranexamic acid injection to cervix- 1 g tranexamic acid diluted in 10 ml saline

Intervention Type DRUG

local normal saline injection to cervix

local normal saline injection to the cervix- 20 ml saline

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hexakapron

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yair Daykan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Meir Medical Center

Kfar Saba, Israel, Israel

Site Status NOT_YET_RECRUITING

Meir medical center

Kfar Saba, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yair Daykan, M.D

Role: CONTACT

0542198231

Gal Cohen, M.D

Role: CONTACT

0545915788

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yair M Daykan, MD

Role: primary

972-54-2198231

Yair Dykan, MD

Role: primary

09-7472209

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0354-19-MMC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.