Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery

NCT ID: NCT03085394

Last Updated: 2023-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2022-11-21

Brief Summary

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Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.

Detailed Description

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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.

Conditions

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Intra-Operative Injury - Other Post Operative Hemorrhage Tranexamic Acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment arm

Preoperative intravenous administration of 2g tranexamic acid in 10ml fluid.

Group Type ACTIVE_COMPARATOR

tranexamic acid

Intervention Type DRUG

Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline

Control Arm

Preoperative intravenous administration of 10ml normal saline.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Preoperative intravenous administration of 10 ml saline

Interventions

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tranexamic acid

Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline

Intervention Type DRUG

Placebo

Preoperative intravenous administration of 10 ml saline

Intervention Type DRUG

Other Intervention Names

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Hexakapron

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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David Goitein MD

Head, Bariatric and Metabolic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SMC-17-3846

Identifier Type: -

Identifier Source: org_study_id

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