Tranexamic Acid in Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Tranexamic Acid Adverse Reaction
• Interventions: Other: Transamine 200mg iv

• Registration Number: NCT05696951
• Lead Sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-02
• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-01-20
• Last Update Submitted: 2023-01-20
• Study First Posted: 2023-01-25
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The effectiveness of Tranexamic acid use of sleeve gastrectomy	Transamine 200mg iv	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.
Plasebo grup	Transamine 200mg iv	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.
Sham grup	Transamine 200mg iv	Patients with no bleeding to be treated were not enveloped and were excluded from the intervention or placebo group.

Primary Outcome Measures

Name	Time	Method
effect on bleeding in the first one hours postoperatively	postoperative 1st hours	postoperative bleeding

Secondary Outcome Measures

Name	Time	Method
effect on bleeding in the first 24 hours postoperatively	postoperative 24st hours	The effect of tranexamic acid on early postoperative bleeding

Trial Locations

Locations (1)

Göztepe Prof. Dr. Suleyman Yalcin City Hospital; 🇹🇷 Kadıköy, İstanbul, Turkey