Tranexamic Acid in Sleeve Gastrectomy

Tranexamic Acid Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05696951
• Other study ID #: Bnk723
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 2, 2023

Study information

• Verified date: January 2023
• Source: Goztepe Prof Dr Suleyman Yalcin City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tranexamic Acid Adverse Reaction

Intervention

Other:
• Transamine 200mg iv
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.

Locations

Country	Name	City	State
Turkey	Göztepe Prof. Dr. Suleyman Yalcin City Hospital	Kadiköy	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Goztepe Prof Dr Suleyman Yalcin City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect on bleeding in the first one hours postoperatively	postoperative bleeding	postoperative 1st hours
Secondary	effect on bleeding in the first 24 hours postoperatively	The effect of tranexamic acid on early postoperative bleeding	postoperative 24st hours