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Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss

Primary Purpose

Blood Loss

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
local tranexamic acid injection
local normal saline injection to cervix
IV 1 g tranexamic acid
IV 1 g normal saline
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Meir Medical Center
  • Meir medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

local tranexamic acid injection to cervix

local normal saline injection to cervix

IV 1 g tranexamic acid

IV 1 g normal saline

Arm Description

1 gr of Tranexamic acid diluted in 10 ml saline

20 ml of saline

1 gr of Tranexamic acid diluted in 100 ml saline- IV

100 ml saline- IV

Outcomes

Primary Outcome Measures

Blood loss during operation - measure in ml
At the end of the surgery, surgeon will measure the blood in the suction can

Secondary Outcome Measures

Full Information

First Posted
February 16, 2021
Last Updated
February 18, 2021
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04760301
Brief Title
Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss
Official Title
Local Tranexamic Acid During Vaginal Hysterectomy to Reduce Blood Loss
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
local tranexamic acid injection to cervix
Arm Type
Experimental
Arm Description
1 gr of Tranexamic acid diluted in 10 ml saline
Arm Title
local normal saline injection to cervix
Arm Type
Placebo Comparator
Arm Description
20 ml of saline
Arm Title
IV 1 g tranexamic acid
Arm Type
Experimental
Arm Description
1 gr of Tranexamic acid diluted in 100 ml saline- IV
Arm Title
IV 1 g normal saline
Arm Type
Placebo Comparator
Arm Description
100 ml saline- IV
Intervention Type
Drug
Intervention Name(s)
local tranexamic acid injection
Other Intervention Name(s)
Hexakapron
Intervention Description
local tranexamic acid injection to cervix- 1 g tranexamic acid diluted in 10 ml saline
Intervention Type
Other
Intervention Name(s)
local normal saline injection to cervix
Intervention Description
local normal saline injection to the cervix- 20 ml saline
Intervention Type
Drug
Intervention Name(s)
IV 1 g tranexamic acid
Other Intervention Name(s)
Hexakapron
Intervention Description
IV 1 g tranexamic acid diluted in 100 ml saline
Intervention Type
Other
Intervention Name(s)
IV 1 g normal saline
Intervention Description
IV 100 ml normal saline
Primary Outcome Measure Information:
Title
Blood loss during operation - measure in ml
Description
At the end of the surgery, surgeon will measure the blood in the suction can
Time Frame
End of surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yair Daykan, M.D
Phone
0542198231
Email
yair.dykan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gal Cohen, M.D
Phone
0545915788
Email
galcwork@gmail.com
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba,
ZIP/Postal Code
11125
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yair M Daykan, MD
Phone
972-54-2198231
Email
yair.dykan@gmail.com
Facility Name
Meir medical center
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yair Dykan, MD
Phone
09-7472209
Email
yair.dykan@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss

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