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Enrollment stopped, patients refuse to participate.
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Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Active Comparator | Preoperative intravenous administration of 2g tranexamic acid in 10ml fluid. |
|
| Control Arm | Placebo Comparator | Preoperative intravenous administration of 10ml normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tranexamic acid | Drug | Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficiency (lowering/preventing clinically significant bleeding) | The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding. | 1 week |
| Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events) | The safety of administering tranexamic acid preoperatively without promoting thromboembolic events | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Need for reintervention | The proportion of patients requiring invasive intervention (percutaneous/operative) due to bleeding | 1 week |
| Procedure change | The proportion of patients requiring alteration of intended procedure due to bleeding. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
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| ID | Term |
|---|---|
| D019106 | Postoperative Hemorrhage |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Preoperative intravenous administration of 10 ml saline |
|
| 1 day |
| Blood/blood product requirement | The usage of blood/blood products after surgery | 1 week |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |