Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery (PHORBBS)
Primary Purpose
Intra-Operative Injury - Other, Post Operative Hemorrhage, Tranexamic Acid
Status
Terminated
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
tranexamic acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Intra-Operative Injury - Other focused on measuring Morbid Obesity, Sleeve gastrectomy
Eligibility Criteria
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
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment arm
Control Arm
Arm Description
Preoperative intravenous administration of 2g tranexamic acid in 10ml fluid.
Preoperative intravenous administration of 10ml normal saline.
Outcomes
Primary Outcome Measures
Treatment efficiency (lowering/preventing clinically significant bleeding)
The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding.
Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events)
The safety of administering tranexamic acid preoperatively without promoting thromboembolic events
Secondary Outcome Measures
Need for reintervention
The proportion of patients requiring invasive intervention (percutaneous/operative) due to bleeding
Procedure change
The proportion of patients requiring alteration of intended procedure due to bleeding.
Blood/blood product requirement
The usage of blood/blood products after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03085394
Brief Title
Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
Acronym
PHORBBS
Official Title
Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Enrollment stopped, patients refuse to participate.
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
November 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-Operative Injury - Other, Post Operative Hemorrhage, Tranexamic Acid
Keywords
Morbid Obesity, Sleeve gastrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Active Comparator
Arm Description
Preoperative intravenous administration of 2g tranexamic acid in 10ml fluid.
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Preoperative intravenous administration of 10ml normal saline.
Intervention Type
Drug
Intervention Name(s)
tranexamic acid
Other Intervention Name(s)
Hexakapron
Intervention Description
Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Preoperative intravenous administration of 10 ml saline
Primary Outcome Measure Information:
Title
Treatment efficiency (lowering/preventing clinically significant bleeding)
Description
The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding.
Time Frame
1 week
Title
Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events)
Description
The safety of administering tranexamic acid preoperatively without promoting thromboembolic events
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Need for reintervention
Description
The proportion of patients requiring invasive intervention (percutaneous/operative) due to bleeding
Time Frame
1 week
Title
Procedure change
Description
The proportion of patients requiring alteration of intended procedure due to bleeding.
Time Frame
1 day
Title
Blood/blood product requirement
Description
The usage of blood/blood products after surgery
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
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