Clinical Trial of Surgery Medication Hetastarch: Issues in Study Oversight Caused Brain Damage, Other Health Problems for Heart Surgery Patients

During a 14 month period between December 1991 and February 2001, a number of heart patients who underwent surgery at the Columbia University Medical Center (which has since become part of the New York Presbyterian Hospital) may have been unknowingly part of a clinical trial of a surgical fluid expander known generically as Hetastarch.

Hetastarch is manufactured by Chicago-based Abbott Laboratories, which also manufactures the drug under the brand name of Hextend. In addition, the drug is also sold under the brand name Hespan.

Problems with the Columbia Clinical Trial Study
A number of questions came to light about serious problems with the study, leading to an investigation by the Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP).

The purpose of the clinical trial study was to evaluate the use of Abbott’s new formulation of Hextend, whether it was safer than other forms of the drug, and whether it could be administered in higher doses than other forms of Hetastarch.

Of particular concern during the OHRP investigation was whether the patients documented in the study had been properly and adequately informed of their participation in the study and the possible complications should they be given Hextend during surgery.

While specific information about the patients in the study have not been disclosed, the OHRP investigation did note that a number of the patients were New Yorkers who lived in a low-income, predominately Spanish-speaking neighborhood near Columbia Hospital. In addition, the investigation showed that these Spanish-speaking patients had been admitted to the hospital directly from the Columbia emergency room.

Patient Injuries Caused by Hetastarch
The OHRP investigation showed that approximately half of the patients documented in the study received high doses of Hextend during surgery, while the other group of patient received traditional doses of Hetastarch.

While both drugs were administered to replace blood and other fluid loss during surgery, higher doses can prevent blood from clotting. For patients already undergoing a serious medical procedure like open heart surgery, the adverse affects of a Hetastarch overdose can lead to hemorrhaging, brain damage, organ failure and death.

As a result of the OHRP investigation, Columbia Hospital was ordered to locate the patients and their families in order to advise them about the likelihood that their loved one may not have been properly informed about the nature of the study and the risk of injury. The OHRP has also ordered Columbia to provide an analysis of the surgical and post-operative status of all of the patients included in the study.

Legal Rights of Clinical Health Trial Participants
The U.S. Food and Drug Administration (FDA) has the responsibility for the oversight regarding the research and testing of all drugs. In the cases of a clinical trial, the FDA requires that all potential participants be provided with specific information about the clinical trial, their likelihood they will receive the trial drug, the dosage they will receive and any possible side-effects that could result by being given the drug.

Heart Surgery Risks

Heart surgery lawsuit information: Hetastarch study at NYC hospital
Info for NYC Columbia Hospital heart surgery patients given Hetastarch

Clinical Trial Study

Free lawsuit info: Hetastarch study at Columbia University Hospital
Legal info about NYC Columbia University Hospital Hetastarch study

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