UF Bruce Spiess presses for urgent action on blood substitutes
By Department of Anesthesiology
As the coronavirus (COVID-19) pandemic continues to escalate, experts are warning of a dire shortage of blood as donors stay home and blood drives across the country are canceled.
The current crisis highlights the critical need for the federal government to approve and begin manufacturing oxygen therapeutics, or blood substitutes, said Bruce Spiess, MD, FAHA, a national expert in blood management. These therapeutics have been tested and are available in other countries, including Russia, China, Mexico, and South Africa.
Estimates based on U.S. Food and Drug Administration (FDA) pandemic modeling indicate the country could be facing a 5% to 7% reduction in weekly blood donations, leading to a shortage of more than 500,000 units of blood over the next year. This assumes supply chains remain intact, which is unlikely to be the case with COVID-19. Blood donations may drop by as much as 60% in some areas of the country that have essentially shut down and restricted all public activities to prevent the spread of the novel coronavirus, such as Seattle and San Francisco.
People should continue to donate blood while taking appropriate precautions and following guidelines from the Centers for Disease Control and Prevention about social distancing and hand washing, said Dr. Spiess, Professor of Anesthesiology and Associate Chair of Research.
Two pharmaceutical technologies are available as blood substitutes: hemoglobin-based (human and bovine) oxygen carriers (HBOCs) and perfluorocarbon (PFC) fluids and emulsions.
While large clinical trials of blood substitutes have not yet been completed, the products are clearly more effective than not having a blood supply, which is the situation the United States is now facing, Dr. Spiess said.
“In the situation where blood is not an option, they [HBCOs and PFCs] are safer than severe anemia, organ failure, and death,” he said.
HBOCs have been used in thousands of humans, including more than 250 patients who cannot accept blood. PFCs have been used in more than 3,000 humans in trials with only minor side effects.
UF Health is the only institution in the country that has a compassionate-use license from the FDA for the use of Hemopure, or HBOC-201, a bovine hemoglobin product that works as a “bridge” by delivering oxygen while the body regenerates its own blood. The license means it can be used when there are no other options available in patients who qualify.
“We have enough data to say it’s safe and effective for patients who can’t get blood and that’s the situation we have now,” Dr. Spiess said. But he stressed that our institution’s supply is limited.
Dr. Spiess has intensified his public campaign to action, urging Congress to take immediate steps to get Hemopure FDA approved and ramp up manufacturing production. He’s had substantial conversations with local U.S. Rep Ted Yoho, R-FL, who has a personal connection to the issue.
He also provided his expertise for a lengthy piece on blood substitutes in the April 2020 issue of Men’s Health magazine, which notes that Hemopure has been approved for hospital use in South Africa for decades.
A recently completed case study of HBOC-201 set to be published in the journal Transfusion did not report any organ failure or deaths in a subset of data of 41 patients who received expanded access to HBOC-201.
The problem, Dr. Spiess stressed, is that the profitable blood bank industry has perpetuated biases against substitutes.
Now, “we’re on the edge of the precipice looking down,” he said.
Patients with COVID-19 are not likely to need blood transfusions and could even be placed at greater risk if they undergo one, but the concern is the dire shortage for other hospitalized patients.
Health officials at the FDA and the American Association of Blood Banks have said that COVID-19 cannot spread through blood, but this remains unknown because blood has not yet been tested, Dr. Spiess said.
“We can’t say it’s not there if we don’t test,” Dr. Spiess said.
Dr. Spiess is also urging the FDA to take action on the potential to use PFCs for acute respiratory distress syndrome and respiratory failure. PFCs carry 60 times the amount of oxygen that human blood carries, and fat emulsions of PFCs have been used in cases of oxygen delivery failure. Moreover, pure PFC can be used as a mist to coat the inside of the lungs, leading to enhanced lung function.