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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Haemorrhage Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

The pharmacist also prepared indistinguishable infusion bags containing tranexamic acid (1 g diluted in 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

placebo (100 mL of 0.9% saline).

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

Group Type PLACEBO_COMPARATOR

placebo (100 mL of 0.9% saline).

Intervention Type DRUG

The pharmacist also prepared indistinguishable infusion bags containing 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

Interventions

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

The pharmacist also prepared indistinguishable infusion bags containing tranexamic acid (1 g diluted in 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

Intervention Type DRUG

placebo (100 mL of 0.9% saline).

The pharmacist also prepared indistinguishable infusion bags containing 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

Intervention Type DRUG

Other Intervention Names

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TXA Inert saline

Eligibility Criteria

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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).