NCT04760301

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Feb 2021Jun 2026

First Submitted

Initial submission to the registry

February 16, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

4.4 years

First QC Date

February 16, 2021

Last Update Submit

May 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

local tranexamic acid injection to cervix

EXPERIMENTAL

1 gr of Tranexamic acid diluted in 10 ml saline

Drug: local tranexamic acid injection

local normal saline injection to cervix

PLACEBO COMPARATOR

20 ml of saline

Other: local normal saline injection to cervix

Interventions

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

Also known as: Hexakapron
local tranexamic acid injection to cervix

local normal saline injection to the cervix- 20 ml saline

local normal saline injection to cervix

Eligibility Criteria

Age20 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old female patients going through vaginal hysterctomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Meir Medical Center

Kfar Saba, Israel, 11125, Israel

NOT YET RECRUITING

Meir medical center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yair Daykan, M.D

CONTACT

Gal Cohen, M.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 18, 2021

Study Start

February 16, 2021

Primary Completion

July 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

May 6, 2025

Record last verified: 2025-05

Locations