Clinical Trial: HOPES
The purpose of the HOPES Trial (HypOthermia for Patients requiring Evacuation of Subdural Hematoma: A Multicenter, Randomized Clinical Trial) is to find out if therapeutic hypothermia improves outcome following traumatic brain injury (TBI) which requires surgery.
Therapeutic hypothermia means to lower the body temperature below normal, in this case to about 33°C or 91.4°F (normal body temperature is about 37°C or 98.6°F). This study will also look at the safety of therapeutic hypothermia in the management of brain injury and look at the effect of hypothermia in reducing the occurrence of depolarization in the brain.
Depolarization in the brain are short-circuits (electrical failures) that occur in a specific area of injury and result in dampened brain waves, which has been shown to be harmful. The study will also test to see if the levels of certain proteins in the blood are lowered by hypothermia.
The study will enroll up to a total of 350 people nationally. Patients enrolled in this study will receive hypothermia or normothermia (normal body temperature) randomly, much like rolling dice, with a 50/50 chance of receiving the hypothermia. The catheters used for temperature management in this study have been cleared for use by the FDA. However, therapeutic hypothermia in traumatic brain injury has not been approved as a treatment by the FDA.
In order to be a part of this research study an individual must be between 22-65 years of age and have a head injury, with brain bleeding, which requires surgery. The individual must be enrolled in the study within 6 hours of initial head injury. Inclusion criteria of the study must also be met.
(See more info at Clinical Trials.gov)
Due to the nature of a severe traumatic brain injury, the patient is in a comatose state and cannot agree to participate in a research study themselves. Often times the family is not available or identified early enough to provide their consent. This has led to some individuals being excluded from participating in this trial. The FDA has granted the submission for a waiver of consent to enroll patients who meet the inclusion criteria and have no family available to consent. This waiver is called “Exception from Informed Consent” (EFIC).
Patients between the ages of 22-65 who get to the hospital quickly with a severe head bleed requiring surgery can be included. Because head injury is a life threatening condition requiring immediate treatment, some subjects will be enrolled without consent until a family member can be located. Every attempt will be made to locate family to review the study.
The research study has few risks. They include:
- Risks associated with cooling include irregular heart rhythms, shivering, electrolyte disorders, elevated blood sugar, hypovolemia (decreased volume of circulating blood), pneumonia, blood clotting or bleeding and some risk of infection around the intravascular cooling devices.
- A rare risk associated with seizure activity strip may be infection from placement or allergic reaction to the seizure activity strip.
- An unlikely risk of infection from the indwelling tubes placed to monitor pressure in the brain and sample cerebral spinal fluid as part of routine care.
If you would like more information on this study or would like to decline participation in advance, please contact us at firstname.lastname@example.org and provide your name and contact information.
The principal investigator of this study is David O. Okonkwo, MD, PhD.
Clinical Trial Info: