Tranexamic Acid in Sleeve Gastrectomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05696951

Enrollment

200

Registered

2023-01-25

Start date

2022-01-01

Completion date

2023-01-02

Last updated

2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tranexamic Acid Adverse Reaction

Keywords

tranexamic acid, Sleeve gastrectomy, Postoperative bleeding

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.

Interventions

OTHERTransamine 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
effect on bleeding in the first one hours postoperatively	postoperative 1st hours	postoperative bleeding

Secondary

Measure	Time frame	Description
effect on bleeding in the first 24 hours postoperatively	postoperative 24st hours	The effect of tranexamic acid on early postoperative bleeding

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026