A Winnipeg-based research team has discovered a product used worldwide to resuscitate critically ill patients with low blood pressure may be doing more harm than good.
The team's research is being published in today's edition of the Journal of the American Medical Association. It concludes that hydroxyethyl starches (HES), the most common blood-volume expanders in use, can cause increased kidney failure and higher mortality rates than other products.
Dr. Ryan Zarychanski, a CancerCare Manitoba hematologist and the study's lead researcher, said publication of the team's findings could change the way hospitals and government regulators around the world view HES.
"I'm really excited to get this out because by using the product less, more people will actually live," he said in an interview. Zarychanski and his team examined 38 clinical trials involving corn-based HES solutions. The trials involved 10,880 patients from around the world. HES has been on the market since the 1980s.
Zarychanski, a critical care physician who also teaches at the University of Manitoba, said problems with HES might have been detected earlier if not for previously published studies conducted by a German investigator that were later retracted due to scientific misconduct.
"When you remove the data from that one investigator (seven studies' worth), the evidence of harm is even more clear," he said.
Zarychanski said there are several alternatives to HES -- some of them far less expensive than the product sold under such trade names as Hespan and Voluven.
HES and other synthetics were introduced to reduce the medical community's reliance on human blood products. Several of these alternatives, though, have been found to cause harm, prompting restrictions on their use.
"I'm expecting that physicians will immediately reconsider the use of (HES) on a day-to-day basis. I'm expecting that hospitals will re-examine their decision to carry this... or to carry it without restrictions," he said.
Today's article is the second prestigious medical journal publication in the last six months for Zarychanski. In September, he was the lead author of an article that dominated the cover of Blood, the world's top journal on blood disorders. The report unlocked the secret to a mysterious blood disorder that could lead to improved treatment for patients.
Terry Klassen, an associate dean at the U of M's faculty of medicine, said publication of the HES article -- and a companion editorial on the subject -- in one of the top medical journals in the world "speaks to the quality of research" being done in Winnipeg. "I think it's terribly exciting," he said Tuesday.
Klassen said Zarychanski's study shows the need for "more full disclosure" on the results of clinical trials.
"You can't have industry not disclosing the whole story on a product because that will lead to a distorted view of whether something is safe and whether it works or not," he said.
Zarychanski said HES -- which has been widely used in Winnipeg -- became part of standard care in the absence of properly conducted studies to assess patient safety. These studies have only been recently conducted and were included in the analyses done by himself and his team.
Also participating in the study were Dr. Ahmed Abou-Setta, a physician and scientist at the University of Manitoba, and Dr. Alexis Turgeon, a physician and clinician-scientist at Laval University in Quebec City. Additional support for the research was provided by the George and Fay Yee Centre for Healthcare Innovation, a partnership between the U of M and the Winnipeg Regional Health Authority.