- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03085394
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
Status
Terminated
Intervention / Treatment
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
- Name: Aharon Lubetsky, MD
- Phone Number: +97235302120
- Email: Aharon.Lubetsky@sheba.health.gov.il
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:
|
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMC-17-3846
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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