Traumatic Shock Trial Results Released to the Public

Researchers find patients in both groups did about the same

Trauma patients suffering severe blood loss who receive the current standard of care have about the same odds of survival as those who are given the standard of care plus low-dose vasopressin, although there is a trend towards improved survival in patients who receive low-dose vasopressin. Those were the findings, announced today by University of Texas Health Science Center trauma surgeons at University Hospital. They also concluded that giving a low-dose of vasopressin decreased the total volume of resuscitation fluid needed over the first five days after injury. The study, which began in 2007, was the first trial to investigate the impact of vasopressin administration in trauma patients.

Over the two-year study at University Hospital, 78 critically injured trauma patients were enrolled and randomly assigned to one of the two study groups. Forty of the patients received saline solution, the current standard of care for serious blood loss. The remaining 38 received vasopressin, in addition to saline intravenously (IV). Twenty-four of the 78 patients did not survive their injuries. Of those who died, 11 (14%) were in the vasopressin group and 13 (17%) were in the saline group. Researchers agree the difference in deaths between the two groups of patients is not statistically significant, meaning it is not greater than what would be expected by chance. No deaths or serious adverse events were attributed to participation in the study.

STUDY DESIGN

The study was conducted under a federal regulation that allows research in certain emergent, life-threatening situations using a community consultation plan. This federal regulation allows an Institutional Review Board (IRB) to approve a clinical trial without requiring initial informed patient consent, provided specific criteria are met.

A summary of these criteria include:

• Patients must be in a life-threatening situation.
• The experimental treatment must offer patients the potential for direct clinical benefit in the form of increased survival.
• The risks are reasonable.
• Without an exception from informed consent the research could not be conducted.
• The community in which the study is being conducted is consulted and the findings from the study are reported back to the community.

This study enrolled only patients suffering from shock after a traumatic injury, who were at risk of dying. Shock causes the patient’s blood pressure to become dangerously low and the lack of blood-carrying oxygen to the body’s organs can cause them to have difficulty functioning and potentially stop working. Currently, patients in shock immediately receive saline solution. Once at the hospital they may also receive additional medication, blood products and/or go to the operating room. The delivery of excessive fluids and blood products can cause respiratory failure; severe swelling and tissue damage in the brain, abdomen, arms and legs; bleeding and clotting disorders; and infections. The goal of the Vasopressin Study was to better understand how to reduce these complications and related deaths.

Vasopressin is a drug approved by the Food and Drug Administration (FDA) for patients with Diabetes Insipidus (extreme thirst and frequent urination) and for patients with abdominal swelling after surgery. It is also commonly used for other problems not currently approved by the FDA. These “off label” uses include treatment for heart attack patients and as an alternative drug for patients in shock. Vasopressin has been shown in previous studies to decrease the amount of fluid required to treat shock, so giving it to shock patients rapidly may decrease the likelihood of side effects from excessive fluids and may potentially increase survivability.

The patients enrolled in this study were randomly selected to receive either vasopressin or IV saline solution upon arrival to University Hospital. Treatment continued for five hours after initiation of the study medication. Patients, and their legally authorized representatives or family members, were notified at the earliest opportunity.

WHO WAS ENROLLED?

University Hospital Study Patient Characteristics
78 Subject	Vasopressin	%	Saline Control	%
Age mean	48	---	46	---
Gender
Male	28	36%	33	42%
Female	10	13%	7	9%
Race
Caucasian	19	24%	17	22%
African American	0	0%	4	5%
Hispanic	19	24%	18	23%
Asian	0	0%	0	0%
Other	0	0%	1	1%

WHY STUDY TRAUMA PATIENTS?

This type of groundbreaking clinical research is vitally important to improve injury prevention efforts, as well as survival and quality of life for trauma patients. Injuries destroy the health, lives and livelihoods of millions of people:

• Trauma-related injuries are the leading cause of death among all Americans under the age of 45.
• In Bexar County and South Texas, more children die from injury than from all other causes of death – combined.
• Each year, trauma accounts for 37 million ER visits and 2.6 million hospital admissions.
• Injuries in a single year cost the U.S. $406 billion - $326 billion in lost productivity and $80. 2 billion in medical costs.

CONSULTING THE COMMUNITY

Eighteen community meetings were held in San Antonio and throughout the 22-county trauma region to inform and consult the community. The study was given final approval by the UT Health Science Center. Notices were made of meetings so all individuals interested in learning more about this study, and who wished to offer feedback, could do so.

Now that the study has been completed, and the results have been analyzed, presented at the annual American College of Surgeons and are pending publication in the World Journal of Surgery, local researchers are providing the results of the study to this participating community, as required by the exception to informed consent regulation. Community meeting will be held upon requests to provide in-depth overviews of the study findings to those interested in learning. Additional information is available online at www.surgery.uthscsa.edu/vasostudy.asp or by contacting the UT Health Science Center project coordinator at the UT Health Science Center Department of Surgery, MC: 7740, 7703 Floyd Curl, San Antonio, Texas 78229-3900 or by phone at (210) 567-3623.

UT Medicine San Antonio is the clinical practice of the School of Medicine at The University of Texas Health Science Center San Antonio. With more than 700 doctors – all faculties from the School of Medicine – UT Medicine is the largest medical practice in Central and South Texas, with expertise in more than 60 different branches of medicine. Primary care doctors and specialists see patients in private practice at UT Medicine’s clinical home, the Medical Arts & Research Center (MARC), located in the South Texas Medical Center at 8300 Floyd Curl Drive, San Antonio 78229. Most major health plans are accepted, and there are clinics and physicians at several local and regional hospitals, including CHRISTUS Santa Rosa, University Hospital and Baptist Medical Center. Call (210) 450-9000 to schedule an appointment, or visit the Web site at www.UTMedicine.org for a complete listing of clinics and phone numbers.

Proudly owned by the people of Bexar County, University Health System is a nationally recognized academic medical center, in partnership with the UT Health Science Center School of Medicine. It is the only health organization in South Texas to be recognized as Magnet by the American Nurses Credentialing Center. Only about six percent of U.S. hospitals have earned the Magnet seal for excellence in patient care. University Health System is committed to patient safety and is in the top one percent in the nation for electronic medical records. Facilities include University Hospital (the lead Level I trauma center for 22 Texas counties) and a vast network of community clinics offering primary, specialty and preventive health services. University Health System has embarked on one of the largest construction programs in Bexar County history. The $899.4 million project includes a new 10-story tower at University Hospital and a six-story clinical services building on the Robert B. Green Campus downtown. For more information, visit www.UniversityHealthSystem.com.