NEW YORK (Reuters Health) Dec 13 - Preoperative blood transfusions reduce rates of serious perioperative complications in patients with sickle cell disease, researchers said Sunday at the 53rd annual meeting of the American Society of Hematology (ASH).
The international multicenter randomized TAPS trial showed that patients in the pre-op transfusion arm had far fewer serious adverse events than patients in the non-transfused arm, Dr. Jo Howard, from Guy's and St. Thomas Hospital, London, UK, reported.
In fact, the trial was closed early because of the excess of serious adverse events that began to emerge early on in the non-transfused patients, Dr. Howard said.
"It wasn't clear whether we should transfuse patients with sickle cell disease before surgery or not. There had not been international trials like this before to give us an answer," she told Reuters Health.
Patients with sickle cell disease can become anemic and short of oxygen during surgical procedures, and when this happens their red cells sickle and cause pain and other problems, including acute chest syndrome, Dr. Howard explained.
In the current study, she and her team randomized patients with HbSS and HbSbo thalassemia, the most severe forms of sickle cell disease, to pre-op blood transfusion or no transfusion.
The investigators originally screened 343 patients. They excluded patients with hemoglobin level below 6.5 g/dL, a blood transfusion within the last three months, or severe sickle cell disease. They also considered only patients having low- or moderate-risk elective operations.
Just 70 patients had been randomized into treatment arms when the study was terminated. The final analysis included 34 patients in the transfused arm and 33 in the non-transfused arm. The majority (58%) were having either abdominal or ear, nose and throat surgery.
Perioperative complications occurred in 39% of patients who did not receive pre-op transfusions and in 15% of patients in the transfusion arm.
Furthermore, 30% of patients who did not receive a transfusion had a serious adverse event, compared with only 3% of patients who did receive a transfusion.
The majority of SAEs were acute chest syndrome, which is a life threatening complication of sickle cell disease, Dr. Howard reported.
"Doctors should tell their patients that the outcome for patients who are transfused is very good, and if they need an operation and are transfused beforehand, they have a very low risk of having complications. They can reassure them," Dr. Howard said.
Commenting on this study, Dr. Susan B. Shurin, acting director of the National Heart, Lung, and Blood Institute (NHLBI), in Bethesda, Maryland, said it addresses a very significant question in the management of sickle cell disease patients.
"The optimal role of blood transfusion in prevention of complications of surgery has been shown in this study," Dr. Shurin told Reuters Health.
"The incidence of severe adverse events, especially acute chest syndrome, was 2.6 times higher in those who did not receive transfusion," she noted.
The study provides guidance for physicians who are making decisions about management of their patients, and for patients deciding about risks, Dr. Shurin said.
She added, "This study, and others which have addressed the same question, highlight the post-operative risk in patients with sickle cell disease and should enhance the vigilance of those caring for patients in this situation."
The international multicenter randomized TAPS trial showed that patients in the pre-op transfusion arm had far fewer serious adverse events than patients in the non-transfused arm, Dr. Jo Howard, from Guy's and St. Thomas Hospital, London, UK, reported.
In fact, the trial was closed early because of the excess of serious adverse events that began to emerge early on in the non-transfused patients, Dr. Howard said.
"It wasn't clear whether we should transfuse patients with sickle cell disease before surgery or not. There had not been international trials like this before to give us an answer," she told Reuters Health.
Patients with sickle cell disease can become anemic and short of oxygen during surgical procedures, and when this happens their red cells sickle and cause pain and other problems, including acute chest syndrome, Dr. Howard explained.
In the current study, she and her team randomized patients with HbSS and HbSbo thalassemia, the most severe forms of sickle cell disease, to pre-op blood transfusion or no transfusion.
The investigators originally screened 343 patients. They excluded patients with hemoglobin level below 6.5 g/dL, a blood transfusion within the last three months, or severe sickle cell disease. They also considered only patients having low- or moderate-risk elective operations.
Just 70 patients had been randomized into treatment arms when the study was terminated. The final analysis included 34 patients in the transfused arm and 33 in the non-transfused arm. The majority (58%) were having either abdominal or ear, nose and throat surgery.
Perioperative complications occurred in 39% of patients who did not receive pre-op transfusions and in 15% of patients in the transfusion arm.
Furthermore, 30% of patients who did not receive a transfusion had a serious adverse event, compared with only 3% of patients who did receive a transfusion.
The majority of SAEs were acute chest syndrome, which is a life threatening complication of sickle cell disease, Dr. Howard reported.
"Doctors should tell their patients that the outcome for patients who are transfused is very good, and if they need an operation and are transfused beforehand, they have a very low risk of having complications. They can reassure them," Dr. Howard said.
Commenting on this study, Dr. Susan B. Shurin, acting director of the National Heart, Lung, and Blood Institute (NHLBI), in Bethesda, Maryland, said it addresses a very significant question in the management of sickle cell disease patients.
"The optimal role of blood transfusion in prevention of complications of surgery has been shown in this study," Dr. Shurin told Reuters Health.
"The incidence of severe adverse events, especially acute chest syndrome, was 2.6 times higher in those who did not receive transfusion," she noted.
The study provides guidance for physicians who are making decisions about management of their patients, and for patients deciding about risks, Dr. Shurin said.
She added, "This study, and others which have addressed the same question, highlight the post-operative risk in patients with sickle cell disease and should enhance the vigilance of those caring for patients in this situation."
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