Tranexamic Acid Clinical Trial
— PHORBBSOfficial title:
Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
Verified date | April 2023 |
Source | Sheba Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.
Status | Terminated |
Enrollment | 152 |
Est. completion date | November 21, 2022 |
Est. primary completion date | November 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Israel | Sheba Medical Center | Tel Hashomer |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment efficiency (lowering/preventing clinically significant bleeding) | The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding. | 1 week | |
Primary | Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events) | The safety of administering tranexamic acid preoperatively without promoting thromboembolic events | 2 months | |
Secondary | Need for reintervention | The proportion of patients requiring invasive intervention (percutaneous/operative) due to bleeding | 1 week | |
Secondary | Procedure change | The proportion of patients requiring alteration of intended procedure due to bleeding. | 1 day | |
Secondary | Blood/blood product requirement | The usage of blood/blood products after surgery | 1 week |
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