Acute Traumatic Brain Injury Treatment: Improving Recovery from a Traumatic Brain Injury
SyNAPSe
Study of the Neuroprotective Activity of Progesterone in Severe Traumatic Brain Injuries
What is Traumatic Brain Injury?
Traumatic Brain Injury (TBI) is the leading cause of death and disability in children and young adults and is involved in nearly half of all trauma deaths. It results from a blow to the head that injures the brain, such as from a car crash, fall, or assault. Brain injury may occur with or without a skull fracture. The hard skull may not protect the delicate brain from such impacts causing mild to serious injury.
A TBI can cause immediate or delayed symptoms of mental, physical and emotional function. These may include problems with headaches, memory, mood, sleep, and any of the senses. It can possibly lead to temporary or permanent impairment with a lack of or altered state of awareness. It may also result in problems with activities of daily living. Symptoms and problems can occur even some time after the injury.
TBI Treatment
Following a TBI, medical attention should be sought immediately. Studies have shown that the earlier medical treatment is provided to the injured person, the more chance there is for treatment to be effective. Treatment within the first hours of injury can help to prevent further damage to the brain.
Despite many years of research and testing, there is no known effective treatment for TBI. Current TBI treatment is supportive, with primary treatment goals being maintenance of blood pressure and oxygenation, and reduction of secondary brain injury through control of increased intracranial pressure.
Initial treatment of a TBI patient upon arrival at the hospital will focus on resuscitation procedures, monitoring the body's vital functions, and responding to critical life-threatening conditions.
Once the patient is stabilized, acute treatment will focus on life support and minimizing secondary injury. Treatment could include mechanical ventilation, medication to sedate the patient, medication to prevent seizures, or a device may be placed surgically in the brain to monitor and help control intracranial pressure.
After the patient has been released from the hospital, additional rehabilitation or therapy may be needed for 6 months to 2 years.
What is SyNAPSe?
SyNAPSe is a Phase 3 clinical trial on the use of progesterone treatment: a total of 1180 patients with severe TBI at approximately 100 medical facilities around the world will be enrolled. Two previous studies using progesterone treatment for TBI showed efficacy and an acceptable safety profile. The development of a therapeutic agent for the successful treatment of TBI will provide significant benefits to patients and society. Potential benefits include:
- Efficacious treatment for TBI patients, where there is currently an unmet medical need
- Decreased mortality from brain injury
- Reduction of short-term and long-term disability (mental and/or physical)
Results from the SyNAPSe trial may lead to the first ever FDA-approved treatment for severe TBI. The trial is sponsored by BHR Pharma, LLC.
Why Progesterone?
Progesterone is a naturally produced hormone in men and women. One of the functions of progesterone is to serve as a protector of the brain. Progesterone has been found to play an important role in promoting and enhancing repair after Traumatic Brain Injury. It may decrease post-injury swelling of the brain and improve mental recovery, especially when given quickly after the TBI occurs.
Why 8 hours?
Studies of progesterone for TBI show that the earlier progesterone is given the better the chance to prevent further damage and improve recovery. In this study, the study drug must be given within 8 hours of the TBI.
How does a TBI patient participate in SyNAPSe?
To be eligible for the SyNAPSe clinical trial, a patient must have a family member available very quickly to provide informed consent; patients may be male or female, must be 16-70 years old (or as required by the participating hospital); weigh 45-135 kg; had a closed head trauma no more than 8 hours before start of the study drug infusion; TBI diagnosed by doctor examination and CT scan of the brain.
Eligible patients must be admitted to a participating medical facility and study treatment must be started within 8 hours of injury.
