Clinical trial

Efficacy of Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements at Centro Medico de Occidente'

NCT05855590

Name

Tranexamic project

Description

Tranexamic acid in debridement surgery of burns on the volume of bleeding in transfusion requirements

Trial arms

Trial start

2022-01-01

Estimated PCD

2022-01-01

Trial end

2023-12-30

Status

Recruiting

Phase

Early phase I

Treatment

Tranexamic acid

10mg/kg intravenous single dose

Arms:

tranexamic acid

0.9% isotonic saline solution

100 ml intravenous single dose

Arms:

placebo

Size

Primary endpoint

Compare the group with tranexamic acid with the group with saline solution.

The time frame: the total time of the study is during the first day, only one dose will be given, and they will be compared at 24 hours.

Eligibility criteria

Inclusion Criteria: 1. First-time patients undergo surgical debridement of their burns. 2. A burn percentage of 10-30% of burned body surface area 3. Patients over 18 years of age 4. Patients under 40 5. IMSS beneficiaries Exclusion Criteria: 1. Burned patients with previous surgical debridement. 2. Patients with co-morbids. 3. Patients with a history of drug hypersensitivity. 4. Patients with kidney disease.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Randomized, double-blind, prospective trial to establish the effect of intraoperative tranexamic acid in early surgical debridement of severe burns. The study was carried out between the months of January 2022 to December 2022.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2023-05-11

1 organization

1 product

1 indication

Organization

Instituto Mexicano del Seguro Social

Product

Tranexamic acid

Indication

Burns