UAB Aims To Improve Dismal Trauma Statistics With Infusions To Be Given By Paramedics

UAB and nine other centers in North America are launching an attack on trauma, the leading cause of death for Americans between 1 and 44 years of age. It may lead to better treatments for wounded soldiers, wreck victims and others.

July 27, 2006

BIRMINGHAM, Ala. – UAB and nine other centers in North America are launching an attack on trauma, the leading cause of death for Americans between 1 and 44 years of age. It may lead to better treatments for wounded soldiers, wreck victims and others.

The federally funded clinical trial will involve patients who have suffered blood loss due to traumatic events such as car crashes, gunshot or knife wounds, or a blow to the head. Unless the eligible patients have previously indicated that they do not want to participate in the trial, medics responding to an emergency will give them one of three intravenous saline solutions – normal saline as is now the standard treatment, or a more concentrated saline solution either alone or with dextran, a sugar solution.

Trauma care specialists believe that both of the concentrated doses have the potential to help survivors by increasing blood flow and delivery of oxygen to the patient’s vital organs.

Efforts to test treatment of trauma patients previously were stymied by the fact that many of the injured are unconscious and unable to provide informed consent to participate in clinical studies. New federal guidelines grant a waiver for such a study if it is widely publicized in advance. Conscious patients would be asked for consent, but consent would be assumed if the trauma victim is unconscious – although the patient’s spouse or other legal representative, if present, would be informed of the options and asked to provide consent.

People who do not want to participate in the ROC clinical trials can go to website www.uab.edu/arc to learn more about the opt-out procedure and to link with the Electronic Patient Information system (EPI). Those without computer access can call 205-934-9532 for assistance.

Thomas Terndrup, M.D, chair of the Department of Emergency Medicine, is the lead UAB representative for the Resuscitation Outcomes Consortium (ROC). The ROC conducts clinical trials with funding from the National Heart, Lung, and Blood Institute, primary sponsor of the $50 million program. A second ROC trial in Birmingham will start later this year and target victims of cardiac arrests. “There is a high probability that patients will benefit from participating in the trials,” Terndrup said.

Principal investigator for the trial of the saline solutions is trauma surgeon Jeffrey Kerby, M.D. Ph.D., associate professor of surgery. Kerby said, “Life-threatening traumatic injury is a serious public health issue. Initial basic research and previous small studies on the concentrated saline solutions have shown that they are safe and potentially have a life-saving effect. This clinical trial will provide the large-scale proof of effectiveness that is needed to lead to widespread adoption and use as standard-of-care.”

Joe Acker, executive director of Birmingham Regional Emergency Medical Services System (BREMSS) and the EMS system liaison for the studies, said, ”This is a unique opportunity for Birmingham and this region to participate in a ground breaking study in EMS. So often we in EMS just follow what works in the hospital and assume it works well for the patient in pre-hospital care. This study as well as others to follow will determine scientifically what we can best do to help patients in the first minutes after a life threatening event.”

As many as 5,000 people will be included in the consortium’s studies, with some 700 involved in this initial UAB trial.

Eligible trauma patients are those ages 15 and above who show signs of blood loss or severe brain injury. In the field, before blood transfusions can be safely administered in hospital, trauma patients would be immediately randomized to receive one of the three solutions intravenously to compensate for blood loss and buy time to get to an emergency department. Neither paramedics nor hospitals would know which of the solutions is being given, although the ROC data center in Seattle would be able to break the code immediately if necessary.

The two concentrated solutions are designed to compensate for blood loss more effectively, lessen excessive inflammatory responses, and prevent brain swelling. These effects could potentially lead to a reduction in organ failure for patients with major blood loss or to improved functional outcome for patients with brain injury, Kerby said.

The ROC trials will be conducted under strict FDA guidelines that allow for patients in life-threatening situations to take part in research without individual consent when they are enrolled in a trial. The guidelines specify criteria that must be followed for a study to have an exception from informed consent. These include:

  • Approval by a UAB Institutional Review Board.
  • Consultation with the community.
  • Public disclosure of the study’s design before the study begins, and public sharing of the results with the study is over.
  • Notification of patients who were involved in the research.
  • Oversight by an independent group of experts charged with monitoring the research for safety.

Participating Cities

Birmingham, Ala.; Dallas, Tex.; Iowa City, Iowa; Milwaukee, Wisc.; Pittsburgh, Pa.; Portland, Ore.; San Diego, Calif.; Seattle/King County, Wash.; Ottawa, Ontario/Vancouver, B.C.; Toronto, Ontario.