Tranexamic Acid in Sleeve Gastrectomy

Study Overview
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Brief Summary
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The effectiveness of Tranexamic acid use will be measured in cases of sleeve gastrectomy in bariatric surgery and in early postoperative bleeding.

Detailed Description
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Prospective, comparative and double-blind study with patients aged 18-65 years admitted to bariatric surgery. Selected patients were given or not given venous tranexamic acid (TXA) during anesthesia induction (CG). Anesthesia and thromboprophylaxis protocols were similar between groups. For statistical analysis, χ2 and analysis of variance tests were performed using the SPSS 21.0 ® statistical program at a significance level of p < 0.05.

Official Title
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Use of Tranexamic Acid in Postoperative Early Period Bleeding in Patients Undergoing Sleeve Gastrectomy: A Randomized Controlled Trial

Conditions
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Tranexamic Acid Adverse Reaction

Intervention / Treatment
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* Other: Transamine 200mg iv


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 65 years with an American Association of Anesthesiologists (ASA) physical condition score II or III undergoing bariatric surgery and LSG Exclusion Criteria: history of thromboembolic disease or severe comorbidity (ASA IV or more) platelet antiaggregants or anticoagulants active intravascular coagulation carriers acute occlusive vasculopathy hypersensitivity to the components of the TXA formula.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The effectiveness of Tranexamic acid use of sleeve gastrectomy<br>In this study, it was determined which treatment package would be received by opening the closed envelopes of patients who had at least one point or more bleeding during the operation and had hemostasis with clips. In the intervention group, at the end of the surgery, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) saline. | Other: Transamine 200mg iv<br>* In the intervention group, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes at the end of the surgery. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) SF. The placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours.<br>|
| Placebo Comparator: Plasebo grup<br>The placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours. | Other: Transamine 200mg iv<br>* In the intervention group, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes at the end of the surgery. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) SF. The placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours.<br>|
| Active Comparator: Sham grup<br>Patients with no bleeding to be treated were not enveloped and were excluded from the intervention or placebo group. | Other: Transamine 200mg iv<br>* In the intervention group, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes at the end of the surgery. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) SF. The placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on bleeding in the first one hours postoperatively | postoperative bleeding | postoperative 1st hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on bleeding in the first 24 hours postoperatively | The effect of tranexamic acid on early postoperative bleeding | postoperative 24st hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, Sleeve gastrectomy, Postoperative bleeding