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Studies Assess Hydroxyurea Therapy and Pre-Operative Transfusions for Patients with Sickle Cell Disease
Date:12/11/2011

re randomized to two treatment arms: patients in Arm A received a pre-operative blood transfusion, while patients in Arm B did not. The primary outcome of the TAPS trial was the proportion of patients experiencing any significant complication between time of randomization into the study and 30 days post-surgery.

Of the 343 patients screened for the trial, 70 were randomized into treatment arms at time of study termination. The trial was closed early because of an excess of serious adverse events (SAEs), which were a subset of complication reports, in the untransfused arm (Arm A). Thirty-three patients in Arm A and 34 patients in Arm B were included in the final analysis. Researchers found that 39 percent of patients who did not receive pre-operative transfusions experienced a perioperative complication, compared to 15 percent of patients in the transfusion arm. There was also a difference in the rate of SAEs between the two arms; 30 percent of patients who did not receive a transfusion experienced an SAE, compared to only 3 percent of patients who received one prior to surgery. The majority of SAEs reported were acute chest syndrome, a life threatening complication of SCD.

"Currently, many patients with SCD are not receiving pre-operative transfusions, which may be putting them at risk of serious complications. The results from our trial demonstrate a striking increase in the total number of complications, both common and life-threatening, in patients who did not receive a blood transfusion before surgery," said lead author Jo Howard, MD, Consultant Hematologist at Guy's and St. Thomas Hospital in London. "Moving forward, we recommend that clinicans take these results into consideration when deciding on pre-operative transfusion and suggest that patients with HbSS and HbSB(degree) thalassaemia receive a blood transfusion before surgery."

The TAPS trial and was sponsored and funded by NHS Blood and Transplant in the United Kingdo
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SOURCE American Society of Hematology
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