Updated May 2024
Sometimes, when you’re bleeding to death, a blood transfusion is not an option.
A mother injured during an earthquake in California needs a blood transfusion. A soldier in an austere environment with no ready access to a blood bank has just lost a leg. A chronic anemia sufferer is in the middle of a sickle cell crisis, but she’s been transfused so many times that her body produces antibodies that attack any new blood.
In dire situations like these, there is a blood alternative with the potential to save these patients’ lives: Hemopure. Hemopure is a bovine hemoglobin-based oxygen-carrying solution, and UF Health now has access to it.
Bruce Spiess, MD, emeritus professor of anesthesiology, is one of the leading advocates for oxygen therapeutics in the United States. He authored Perioperative Transfusion Medicine, the largest textbook available regarding transfusion issues in surgery. In 2017, he presented information about these products to government leaders at a meeting for the U.S. military’s Combat Casualty Care Research Program at Fort Detrick, Maryland.
Hemopure will play an important role in UF Health’s expanding blood management program. The program, led by the Department of Anesthesiology in conjunction with the Transfusion Committee and the UF Health Blood Bank and Transfusion Service, aims to encourage the judicious and appropriate use of blood transfusion. The program will help care providers explore every alternative to blood transfusion, including Hemopure. Hemopure, the only drug available in the United States that can act as a bridge while the body regenerates blood, gives UF Health more flexibility in treating these patients.
Blood transfusion carries both known and unknown risks, and the blood supply is dwindling. It is also costly: One bag of blood can cost the hospital $200, and the cost to the patient can reach up to $2000 because of the associated costs of supplies, personnel, testing, and regulatory measures. This cost does not take into account the risks of transfusion.
One population that will benefit from the expansion of the blood management program is Jehovah’s Witnesses. UF Health’s Jehovah’s Witness program, running parallel to the blood management program, is intended to facilitate bloodless medicine techniques that can be applied to all patients.
Hemopure does not serve as a perfect blood substitute, but rather should be used as a bridge to provide the patient time while the body generates more red blood cells. Although it has many advantages over blood — it doesn’t need to be refrigerated, it lasts for 3 years versus 48 days, and it doesn’t have to be cross-matched and typed with patient blood — it can also be risky. Some risks include volume overload and blood clotting, which can result in complications such as heart attack and stroke.
At UF, development of the treatment protocol for Hemopure was led by Marc S. Zumberg, MD, professor of medicine in the Department of Hematology and chair of the Transfusion Committee at UF Health, who has successfully treated multiple patients with Hemopure. The protocol outlines the FDA criteria for use: the team must have exhausted all other possibilities, the patient must have life-threatening anemia, and there must be a hematology consult.
Because it is in its experimental stages, the drug is only available under investigational status through the FDA expanded access program to qualifying patients under specific circumstances. To use it, U.S. institutions must get approval from HbO2 Therapeutics, the local Human Safety Institutional Review Board, and the US Food & Drug Administration. The institution and the treating physician must follow a specific treatment protocol, and they must submit an Investigational New Drug form agreeing to physician accountability and use of the drug in accordance with the treatment protocol.