Skip to main content
OpenTrials
Completed

NCT Number: NCT05696951

Tranexamic Acid in Sleeve Gastrectomy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tranexamic Acid Adverse Reaction Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Göztepe Prof. Dr. Suleyman Yalcin City Hospital

Kadıköy, Istanbul, 34732, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transamine 200mg iv

Other

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.

Primary outcomes

  1. effect on bleeding in the first one hours postoperatively

    Time frame: postoperative 1st hours

    postoperative bleeding

Secondary outcomes

  1. effect on bleeding in the first 24 hours postoperatively

    Time frame: postoperative 24st hours

    The effect of tranexamic acid on early postoperative bleeding

Sponsors and collaborators

Lead sponsor

Goztepe Prof Dr Suleyman Yalcın City Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2023
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.