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

NCT07187258 | Completed Phase 4

• 1 other identifier: MS-204-2024
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Haemorrhage; Bariatric Surgery Candidate

Keywords

bleeding - sleeve gastrectomy (SG)

Outcome Measures

Primary Outcomes (2)

• intraoperative estimated blood loss (EBL

  Volume of blood loss in cm centimeter cubic

  10 DAYS

• BLEEDING IN SLEEVE GASTRECTOMY

  Volume of blood loss in cubic centimeter

  10 DAYS

Study Arms (2)

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

EXPERIMENTAL

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

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

placebo (100 mL of 0.9% saline).

PLACEBO COMPARATOR

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

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

Interventions

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

Also known as: TXA

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

placebo (100 mL of 0.9% saline). 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

Also known as: Inert saline

placebo (100 mL of 0.9% saline).

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Patient with alzheimer disease

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Manial, 1714, Egypt

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mohammed Elshwadfy, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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 Record Dates

• First Submitted: August 23, 2025
• First Posted: September 22, 2025
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)