Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery (PHORBBS)

April 14, 2023 updated by: David Goitein MD, Sheba Medical Center
Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.

Study Overview

Detailed Description

Patients scheduled for primary laparoscopic sleeve gastrectomy for the treatment of morbid obesity will be assigned to receive tranexamic acid vs. placebo before surgery. Intraoperative bleeding will be scored, as well as postoperative bleeding and blood or blood-product requirements. POstoperative venous thromboembolic events will be recorded up to 2 months following surgery.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 3

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 Locations

      • Tel Hashomer, Israel, 52621
        • Sheba Medical Center

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Morbid obesity
  • Approved and scheduled for laparoscopic sleeve gastrectomy

Exclusion Criteria:

  • Previous bariatric surgery
  • Platelet count under 100,000
  • Concurrent anticoagulation treatment
  • Previous venous/atrerial thromboembolic event
  • Known allergy to tranexamic acid
  • History of heparin induced thrombocytopenia
  • Oral contraceptive use
  • Female hormonal replacement therapy
  • Active thromboembolic state
  • Genetic hypercoagulable state

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment arm
Preoperative intravenous administration of 2g tranexamic acid in 10ml fluid.
Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline
Other Names:
  • Hexakapron
Placebo Comparator: Control Arm
Preoperative intravenous administration of 10ml normal saline.
Preoperative intravenous administration of 10 ml saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment efficiency (lowering/preventing clinically significant bleeding)
Time Frame: 1 week
The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding.
1 week
Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events)
Time Frame: 2 months
The safety of administering tranexamic acid preoperatively without promoting thromboembolic events
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for reintervention
Time Frame: 1 week
The proportion of patients requiring invasive intervention (percutaneous/operative) due to bleeding
1 week
Procedure change
Time Frame: 1 day
The proportion of patients requiring alteration of intended procedure due to bleeding.
1 day
Blood/blood product requirement
Time Frame: 1 week
The usage of blood/blood products after surgery
1 week

Collaborators and Investigators

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

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)

September 1, 2017

Primary Completion (Actual)

November 21, 2022

Study Completion (Actual)

November 21, 2022

Study Registration Dates

First Submitted

March 19, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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