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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
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intra-Operative Injury - Other focused on measuring Morbid Obesity, Sleeve gastrectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 19, 2017
Last Updated
April 14, 2023
Sponsor
Sheba Medical Center
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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

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Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery

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