Transfusion Requirements After Head Trauma (TRAHT)

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Traumatic Brain Injury

Treatments: Behavioral: Restrictive transfusion strategy; Behavioral: Liberal transfusion strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT02203292

32520914.3.0000.0068

Details and patient eligibility

About

TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age equal to or greater than 18 years
• Moderate or severe traumatic brain injury, defined as Glasgow coma scale less than or equal to 12 at hospital admission
• Hemoglobin lower than 9.0 g/dL within 7 days from hospital admission

Exclusion criteria

• Glasgow coma scale equal to 3 with dilated pupils bilaterally
• Previous neurological sequelae
• Pregnant women
• Jehovah's Witnesses
• Hemorrhagic shock at randomization
• Moribund patients
• Unable to provide consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Liberal

Active Comparator group

Description:

Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb \< 9.0 g/dL

Treatment:

Behavioral: Liberal transfusion strategy

Restrictive

Experimental group

Description:

Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb \< 7.0 g/dL

Treatment:

Behavioral: Restrictive transfusion strategy