Tranexamic Acid in Sleeve Gastrectomy

Goztepe Prof Dr Suleyman Yalcın City Hospital

Status

Completed

Conditions

Tranexamic Acid Adverse Reaction

Treatments

Other: Transamine 200mg iv

Study type

Interventional

Funder types

Other

Identifiers

NCT05696951

Bnk723

Details and patient eligibility

About

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

Full 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.

Enrollment

200 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 3 patient groups, including a placebo group

The effectiveness of Tranexamic acid use of sleeve gastrectomy

Active Comparator group

Description:

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.

Treatment:

Other: Transamine 200mg iv

Plasebo grup

Placebo Comparator group

Description:

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.

Treatment:

Other: Transamine 200mg iv

Sham grup

Active Comparator group

Description:

Patients with no bleeding to be treated were not enveloped and were excluded from the intervention or placebo group.