Research: Center for Neurosurgical Intensive Care
Current Research Projects
- Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury (funded by NIH grant #P01-NS38660). This project is a randomized clinical trial of erythropoietin in patients with severe traumatic brain injury.
Trial is registered in www.clinicaltrials.gov/– identifier = NCT00313716
Proposal for use of emergency consent exception in trial (link to next page)
- The Role of NOS3 in the Cerebrovascular Response to TBI (funded by NIH grant #R01-NS048428). This clinical study is examining the effect of common single nucleotide polymorphisms of the NOS3 gene on cerebrovascular function (cerebral blood flow, pressure autoregulation, CO2 reactivity) in patients with severe traumatic brain injury.
- Biomarkers of Traumatic Brain Injury (funded by NIH grant #R01-NS052831)
This clinical study is trying to develop a panel of biomarkers that would indicate the presence and severity of brain injury after trauma. Eventually this panel might be used as a simple blood test.
Status of emergency Study of Erythropoietin in Patients with Brain Injury
HOUSTON – Neurosurgery experts at Baylor College of Medicine and The University of Texas Medical School at Houston have since 2006 enrolled 74 severe brain injury patients into a study of the effects of erythropoietin on the recovery of these patients.
Erythropoietin is a form of a protein normally secreted by the kidneys to stimulate production of red blood cells. It is approved for use in patients with low red blood cell counts, but in this study, researchers want to find out if it can aid recovery from brain injury.
Under a special waiver from the U.S. Food and Drug Administration, 21 patients have been enrolled in the study without consent because their relatives or guardians could not be found quickly enough. That waiver was granted after community consultation, and the doctors – Dr. Claudia S. Robertson, professor of neurosurgery at BCM and Dr. Alex B. Valadka, professor and vice chair of neurosurgery at UT – agreed to try to obtain consent as soon as possible.
They have received permission to continue from the families or guardians of 17 of those 21 patients. Two recovered and agreed to continue to take part. One patient died from his injuries before the family could decide, and another left the hospital before he could decide and cannot be contacted now.
Two large erythropoietin studies have been completed since 2006. One, involving 1,460 critically ill patients and published in the New England Journal of Medicine, ((NEJM 2007;347:965) found a lower death rate (8.5 percent) in the group that received erythropoietin than in the group that did not (11.4 percent). When patients with brain injury were separated out, the death rate in the group that received drug was lower (4 percent) than in the group that did not (7.2 percent). This study appeared in the Journal of Trauma. (J Trauma 2008; 65:386).
A German study of stroke patients found more deaths in the group that received erythropoietin (16 percent) than in the group that did not (9 percent). Although the study is not yet published, the FDA reports that half the deaths occurred during the first week after the stroke and were often the result of bleeding in the brain. These stroke patients cannot be directly compared to patients with traumatic brain injury, which is why a separate study needs to be done in trauma patients. For more information, go to http://www.fda.gov/cder/drug/early_comm/epoetin_alfa.htm.
This study is part of a special class involving emergency conditions in which it is difficult or impossible to obtain consent. The FDA recognized this difficulty several years ago and established special rules that involve notifying the community about the study and consulting with the community about whether the study is in the best interest of its members.
As new information becomes available about the study and the drug it is testing, researchers will make that information available.