Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
NCT ID: NCT03085394
Last Updated: 2023-04-19
Study Results
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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TERMINATED
PHASE3
152 participants
INTERVENTIONAL
2017-09-01
2022-11-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment arm
Preoperative intravenous administration of 2g tranexamic acid in 10ml fluid.
tranexamic acid
Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline
Control Arm
Preoperative intravenous administration of 10ml normal saline.
Placebo
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
Placebo
Preoperative intravenous administration of 10 ml saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Approved and scheduled for laparoscopic sleeve gastrectomy
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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David Goitein MD
Head, Bariatric and Metabolic Surgery
Locations
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Sheba Medical Center
Tel Litwinsky, , Israel
Countries
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Other Identifiers
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SMC-17-3846
Identifier Type: -
Identifier Source: org_study_id
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