Overview

This trial is active, not recruiting.

Conditions anemia, traumatic brain injury
Treatments recombinant human erythropoietin, rhepo, placebo
Phase phase 2/phase 3
Sponsor Claudia Sue Robertson
Collaborator National Institute of Neurological Disorders and Stroke (NINDS)
Start date April 2006
End date March 2013
Trial size 200 participants
Trial identifier NCT00313716, P01NS038660, P01NS38660

Summary

The purpose of this study is to determine the effect of early administration of recombinant human erythropoietin on long-term neurological outcome after severe traumatic brain injury.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
recombinant human erythropoietin (rhEpo) administration and hemoglobin transfusion trigger of 10gm/dl
recombinant human erythropoietin, rhepo
The study design is 2x2 factorial with randomization to erythropoietin or placebo and to transfusion trigger 10 gm/dl or 7 g/dl.
(Active Comparator)
recombinant human erythropoietin (rhEpo) administration and hemoglobin transfusion trigger 7gm/dl
recombinant human erythropoietin, rhepo
The study design is 2x2 factorial with randomization to erythropoietin or placebo and to transfusion trigger 10 gm/dl or 7 g/dl.
(Active Comparator)
placebo administration and hemoglobin transfusion trigger 10gm/dl
placebo
an inactive substance
(Active Comparator)
placebo administration and hemoglobin transfusion trigger 7gm/dl
placebo
an inactive substance

Primary Outcomes

Measure
Glasgow Outcome Scale
time frame: at 6 months

Secondary Outcomes

Measure
Disability rating scale
time frame: at 6 months
Cerebral blood flow within 12hr
time frame: at 48 hr and 120 hr post-injury
Cerebrovascular function (pressure autoregulation, CO2 reactivity) on days 1-10 post-injury
time frame: on days 1-10 post-injury
Hemoglobin concentration during ICU stay
time frame: during ICU stay or first 30 days post-injury (whichever comes first)
Number of transfusions of packed red blood cells required
time frame: during ICU stay or first 30 days post-injury (whichever comes first)
Infection rate
time frame: during the first 30 days post-injury

Eligibility Criteria

Male or female participants at least 15 years old.

Inclusion Criteria: - Blunt trauma mechanism of brain injury - Glasgow Coma Score - motor component ≤ 5 (not following commands) on the post-resuscitation neurologic exam - Available for enrollment and administration of study drug within 6 hours of injury Exclusion Criteria: - Penetrating trauma (i.e. gun shot wounds) - Glasgow Coma Score = 3 and bilateral fixed and dilated pupils - Abbreviated Injury Scale score > 5 for any body part except brain - Severe pre-existing chronic disease - Uncontrolled hypertension, defined as mean arterial pressure > 130mmHg despite antihypertensive treatment - Known hypersensitivity to mammalian cell-derived products or human albumin - Currently taking anticoagulants

Additional Information

Official title Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury
Principal investigator Claudia Robertson, MD
Description Traumatic brain injury (TBI) causes a spectrum of cerebrovascular dysfunction, ranging from impaired pressure autoregulation to severe global ischemia (inadequate blood flow). Pressure autoregulation is the ability of an organ to maintain a constant blood flow despite changes in perfusion pressure. Impaired pressure autoregulation causes TBI patients to be more vulnerable to secondary ischemic attacks. Erythropoietin (Epo) is a substance that is normally made by the kidneys and stimulates the production of red blood cells. It is usually given to patients to treat anemia. Scientists recently discovered that Epo also is made in the brain after injury. In animal models of TBI, the brain's production of Epo has numerous protective effects, including reducing inflammation in the brain, reducing death of brain cells, and improving blood flow to the brain. In the laboratory, the effects of this naturally-occurring, protective agent can be enhanced by giving additional amounts intravenously. Because Epo may have beneficial effects for both the injured brain and anemia, scientists are studying the effects of giving Epo to patients with severe TBI. The primary objective of this randomized, placebo-controlled study is to determine the effect of early administration of recombinant human Epo (rhEpo), on long-term neurological outcome in patients with severe TBI. The researchers also will examine the effects of rhEpo administration on the cerebrovascular system, hemoglobin concentration, brain oxygenation, the need for blood transfusion, and on systemic complications. This study consists of 2 parts: 1) a treatment phase, and 2) a monitoring phase. In the treatment phase, participants will be randomly assigned to 1 of 4 groups: a low or high dose rhEPO treatment group or low or high dose placebo group (control group). All other aspects of treatment during the acute post-injury phase will follow the standard treatment protocol for individuals with severe TBI. Generally the treatment phase lasts 1-2 weeks or the amount of time that is required for patients to receive treatment of their TBIs in the ICU (intensive care unit). The monitoring part of the study (which includes recording information from tests performed as part of the standard TBI treatment, as well as some additional tests performed especially for the study) lasts for up to 6 months after the TBI. Information learned in this study may lead to knowledge about whether rhEpo improves outcomes after TBI and about the optimal hemoglobin concentration to maintain in patients with TBI.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.