Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss

February 18, 2021 updated by: Yair Daykan, Meir Medical Center

Local Tranexamic Acid During Vaginal Hysterectomy to Reduce Blood Loss

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Recruiting
        • Meir Medical Center
        • Contact:
      • Kfar Saba,, Israel, 11125
        • Not yet recruiting
        • Meir Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: local tranexamic acid injection to cervix
1 gr of Tranexamic acid diluted in 10 ml saline
Drug: local tranexamic acid injection
local tranexamic acid injection to cervix- 1 g tranexamic acid diluted in 10 ml saline
Other Names:
  • Hexakapron
Placebo Comparator: local normal saline injection to cervix
20 ml of saline
Other: local normal saline injection to cervix
local normal saline injection to the cervix- 20 ml saline
Experimental: IV 1 g tranexamic acid
1 gr of Tranexamic acid diluted in 100 ml saline- IV
Drug: IV 1 g tranexamic acid
IV 1 g tranexamic acid diluted in 100 ml saline
Other Names:
  • Hexakapron
Placebo Comparator: IV 1 g normal saline
100 ml saline- IV
Other: IV 1 g normal saline
IV 100 ml normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss during operation - measure in ml
Time Frame: End of surgery
At the end of the surgery, surgeon will measure the blood in the suction can
End of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0354-19-MMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Loss

Clinical Trials on local tranexamic acid injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe