the Use of Tranexamic Acid to Prevent the Bleeding in Bariatric Surgery

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Haemorrhage; Bariatric Surgery Candidate

Treatments: Drug: tranexamic acid (1 g diluted in 100 mL of 0.9% saline; Drug: placebo (100 mL of 0.9% saline).

Study type: Interventional

Funder types: Other

Identifiers

NCT07187258

MS-204-2024

Details and patient eligibility

About

Our study aims at evaluating the role of tranexamic acid in bariatric surgery since, The effect of conservative therapy using tranexamic acid for postoperative hemorrhage after bariatric surgery is still very much a novel technique. However,Intravenous tranexamic acid at the time of laparoscopic sleeve gastrectomy is associated with a significant reduction of post-operative bleeding with no observed differences in thromboembolic events or mortality.

Full description

Participants were randomized in a 1:1 ratio to receive tranexamic acid or placebo using a computer-generated block randomization sequence (block size = 4) prepared by an independent pharmacist. Allocation concealment was maintained with sequentially numbered, opaque, sealed envelopes. The pharmacist also prepared indistinguishable infusion bags containing either tranexamic acid (1 g diluted in 100 mL of 0.9% saline) or placebo (100 mL of 0.9% saline). The infusion was administered intravenously over 10-15 minutes immediately after induction of anesthesia and before skin incision, at a maximum rate of 100 mg per minute. Blinding was maintained for patients, anesthesiologists, scrub nurses, and all postoperative assessors, while the operating surgeon was necessarily unblinded, becoming aware of allocation only once the envelope was opened in the operating room. All analyses were performed according to the intention-to-treat principle.

Enrollment: 132 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-60 years were eligible if they had a body mass index (BMI) ≥ 35 kg/m², or ≥ 30 kg/m² with at least one obesity-related diseases(type 2 diabetes, hypertension, or obstructive sleep apnea).

Exclusion criteria

• Patients were excluded if they had a known coagulopathy or platelet disorder, a history of venous thromboembolism, myocardial infarction, or cerebrovascular accident, or if they on anticoagulant or antiplatelet therapy within ten days before surgery. Additional exclusion criteria included prior bariatric or major upper abdominal surgery, allergy or hypersensitivity to tranexamic acid, chronic kidney disease (stage 4-5), significant hepatic impairment, pregnancy or lactation.

Patient with alzheimer disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

132 participants in 2 patient groups, including a placebo group

tranexamic acid (1 g diluted in 100 mL of 0.9% saline

Experimental group

Description:

TXA 1gm dilutedin 100 ml of .9% normal saline Will be given as IV infusion Before anasthesia

Treatment:

Drug: tranexamic acid (1 g diluted in 100 mL of 0.9% saline

placebo (100 mL of 0.9% saline).

Placebo Comparator group

Description:

Placebo diluted in 100 ml of .9% normal saline Will be given as IV infusion Before anasthesia

Treatment:

Drug: placebo (100 mL of 0.9% saline).