Overview: For Public

Background

Blood transfusions are used very commonly in sick patients. In the United States, more than 11 million units are transfused each year. Between 60% and 70% of blood transfusions are given to patient undergoing surgery and the majority of blood transfusions are given to older patients. Despite the common use of red blood cell transfusions, Doctors are not sure how much blood people need after surgery. This study is being done to help determine when blood transfusions should be given to patients after surgery for broken hip. The purpose of this study is to compare two plans for giving blood transfusions to patients. Some doctors give a blood transfusion to keep the blood concentration about 10 grams. Other doctors wait until the blood count is less than 8 grams before giving a blood transfusion. Healthy people have blood counts above 12 grams. Doctors are unsure how much blood patients need to optimally recover after surgery. With more knowledge and understanding of how blood transfusion improves recovery from surgery, we hope to provide more effective and timely treatment so that a greater number of patients can enjoy a complete recovery.

How are People Chosen to Participate in the Study?

For approximately the three and one half years 2600 individuals age 50 and older who have broken a hip and have been admitted to a participating hospital within the United States or Canada will be asked to participate in the study. The orthopedic surgeons from each of these hospitals have approved and support the study. Patients will be explained how the study works and will be asked to give consent to enter the study.

What is Involved in Participation?

After surgery is completed, we will measure the blood count for 3 days. Patients with enough blood loss to reduce their blood concentration below 10 grams will be assigned a blood plan by a set by random rules of research (like a coin flip). One group will receive a blood transfusion at that time and enough blood to keep their blood concentration equal to or above 10. The second group will only receive blood if their blood concentration is less than 8 grams or if their doctor identifies symptoms that would get better with blood transfusion. After the patient leaves the hospital, the study nurse will review the hospital chart. The study nurse will keep in touch with each participant after they leave the hospital by calling them twice, once at 30 days and again at 60 days after their operation. She/he will ask questions about how they are feeling, and what activities they can do.

What will Happen with the Information Provided?

The information provided will be combined with that supplied by the other participants in the study. Every participant's identity will be kept secret. It will never be possible to identify any individual in the study. The doctors who run the study will prepare scientific papers and presentations that tell other doctors which blood plan worked the best.

Who is Conducting this Study?

This study is being conducted by researchers affiliated with the UMDNJ-Robert Wood Johnson Medical School, University of Maryland, and many other medical centers in the United States and Canada. These researchers include specialists in orthopedic surgery, internal medicine, cardiology transfusion medicine, gerontology, nursing, and other disciplines. The National Heart, Lung and Blood Institute has provided funding for this investigation.