Preoperative Transfusions Benefit Severe Sickle Cell Patients

SAN DIEGO – Patients who had severe sickle cell disease and underwent surgery without a preoperative blood transfusion had more than twice as many perioperative complications and 10 times as many severe adverse events as similar patients who received transfusions.

Those are key findings from the TAPS (Transfusion Alternatives Preoperatively in Sickle Cell Disease) trial, a randomized study that was carried out between November 2007 and March 2011 at 22 sites in the United Kingdom, the Netherlands, and Canada.

The findings "show that patients with severe sickle cell disease should be given a blood transfusion before surgery," Dr. Jo Howard said during a press briefing at the annual meeting of the American Society of Hematology. "In addition, it suggests that we should consider giving a blood transfusion to patients with other types of sickle cell disease."

The purpose of TAPS was to assess the clinical benefit of preoperative transfusion to alleviate perioperative complications in patients with sickle cell disease who had sickle cell anemia (HbSS) and sickle-beta⁰-thalassemia (HbSbeta⁰) and who were undergoing low- or medium-risk procedures such as abdominal surgery or tonsillectomy.

"Prior to the trial, it was clear that patients with sickle cell disease having surgery were more likely to have complications, but it wasn’t clear whether transfusion decreased these or not, and in which situations [transfusion] should be used," said Dr. Howard, a consultant hematologist at Guy’s and St. Thomas’ Hospitals, London. "In the United Kingdom in 2005, there was a wide variation in practice, and in fact a decrease in use of blood transfusions in part because of concern about the risks of transfusions."

The primary outcome of the trial was the number of patients with severe sickle cell disease who had significant complications from randomization to 30 days post surgery. The researchers also tracked the amount of blood received, the number of days spent in the hospital, and the readmission rates.

Of 343 patients initially screened for the trial, 70 were randomized into one of two groups. The 35 patients in group 1 did not receive a blood transfusion. The 35 in group 2 received a top-up transfusion if their hemoglobin levels were less than 9g/dL, or a partial exchange if their hemoglobin levels were 9g/dL or higher. The trial was closed in March of 2011 because a higher proportion of serious adverse events occurred in group 1, compared with group 2.

The final analysis included 33 patients in group 1 and 34 patients in group 2. Dr. Howard reported that 39% of patients in group 1 experienced a perioperative complication, compared with 15% of patients in group 2.

In addition, 30% of patients in group 1 and 3% in group 2 experienced a serious adverse event, primarily acute chest syndrome (seen in 27% of patients in group 1 and in 3% of patients in group 2).

Dr. Howard acknowledged certain limitations of TAPS, including its early closure and the relatively small number of patients enrolled in the trial.

The TAPS trial was sponsored and funded by National Health Service Blood and Transplant in the United Kingdom.

SAN DIEGO – Patients who had severe sickle cell disease and underwent surgery without a preoperative blood transfusion had more than twice as many perioperative complications and 10 times as many severe adverse events as similar patients who received transfusions.

Those are key findings from the TAPS (Transfusion Alternatives Preoperatively in Sickle Cell Disease) trial, a randomized study that was carried out between November 2007 and March 2011 at 22 sites in the United Kingdom, the Netherlands, and Canada.

The findings "show that patients with severe sickle cell disease should be given a blood transfusion before surgery," Dr. Jo Howard said during a press briefing at the annual meeting of the American Society of Hematology. "In addition, it suggests that we should consider giving a blood transfusion to patients with other types of sickle cell disease."

The purpose of TAPS was to assess the clinical benefit of preoperative transfusion to alleviate perioperative complications in patients with sickle cell disease who had sickle cell anemia (HbSS) and sickle-beta⁰-thalassemia (HbSbeta⁰) and who were undergoing low- or medium-risk procedures such as abdominal surgery or tonsillectomy.

"Prior to the trial, it was clear that patients with sickle cell disease having surgery were more likely to have complications, but it wasn’t clear whether transfusion decreased these or not, and in which situations [transfusion] should be used," said Dr. Howard, a consultant hematologist at Guy’s and St. Thomas’ Hospitals, London. "In the United Kingdom in 2005, there was a wide variation in practice, and in fact a decrease in use of blood transfusions in part because of concern about the risks of transfusions."

The primary outcome of the trial was the number of patients with severe sickle cell disease who had significant complications from randomization to 30 days post surgery. The researchers also tracked the amount of blood received, the number of days spent in the hospital, and the readmission rates.

Of 343 patients initially screened for the trial, 70 were randomized into one of two groups. The 35 patients in group 1 did not receive a blood transfusion. The 35 in group 2 received a top-up transfusion if their hemoglobin levels were less than 9g/dL, or a partial exchange if their hemoglobin levels were 9g/dL or higher. The trial was closed in March of 2011 because a higher proportion of serious adverse events occurred in group 1, compared with group 2.

The final analysis included 33 patients in group 1 and 34 patients in group 2. Dr. Howard reported that 39% of patients in group 1 experienced a perioperative complication, compared with 15% of patients in group 2.

In addition, 30% of patients in group 1 and 3% in group 2 experienced a serious adverse event, primarily acute chest syndrome (seen in 27% of patients in group 1 and in 3% of patients in group 2).

Dr. Howard acknowledged certain limitations of TAPS, including its early closure and the relatively small number of patients enrolled in the trial.

The TAPS trial was sponsored and funded by National Health Service Blood and Transplant in the United Kingdom.

SAN DIEGO – Patients who had severe sickle cell disease and underwent surgery without a preoperative blood transfusion had more than twice as many perioperative complications and 10 times as many severe adverse events as similar patients who received transfusions.

Those are key findings from the TAPS (Transfusion Alternatives Preoperatively in Sickle Cell Disease) trial, a randomized study that was carried out between November 2007 and March 2011 at 22 sites in the United Kingdom, the Netherlands, and Canada.

The findings "show that patients with severe sickle cell disease should be given a blood transfusion before surgery," Dr. Jo Howard said during a press briefing at the annual meeting of the American Society of Hematology. "In addition, it suggests that we should consider giving a blood transfusion to patients with other types of sickle cell disease."

The purpose of TAPS was to assess the clinical benefit of preoperative transfusion to alleviate perioperative complications in patients with sickle cell disease who had sickle cell anemia (HbSS) and sickle-beta⁰-thalassemia (HbSbeta⁰) and who were undergoing low- or medium-risk procedures such as abdominal surgery or tonsillectomy.

"Prior to the trial, it was clear that patients with sickle cell disease having surgery were more likely to have complications, but it wasn’t clear whether transfusion decreased these or not, and in which situations [transfusion] should be used," said Dr. Howard, a consultant hematologist at Guy’s and St. Thomas’ Hospitals, London. "In the United Kingdom in 2005, there was a wide variation in practice, and in fact a decrease in use of blood transfusions in part because of concern about the risks of transfusions."

The primary outcome of the trial was the number of patients with severe sickle cell disease who had significant complications from randomization to 30 days post surgery. The researchers also tracked the amount of blood received, the number of days spent in the hospital, and the readmission rates.

Of 343 patients initially screened for the trial, 70 were randomized into one of two groups. The 35 patients in group 1 did not receive a blood transfusion. The 35 in group 2 received a top-up transfusion if their hemoglobin levels were less than 9g/dL, or a partial exchange if their hemoglobin levels were 9g/dL or higher. The trial was closed in March of 2011 because a higher proportion of serious adverse events occurred in group 1, compared with group 2.

The final analysis included 33 patients in group 1 and 34 patients in group 2. Dr. Howard reported that 39% of patients in group 1 experienced a perioperative complication, compared with 15% of patients in group 2.

In addition, 30% of patients in group 1 and 3% in group 2 experienced a serious adverse event, primarily acute chest syndrome (seen in 27% of patients in group 1 and in 3% of patients in group 2).

Dr. Howard acknowledged certain limitations of TAPS, including its early closure and the relatively small number of patients enrolled in the trial.

The TAPS trial was sponsored and funded by National Health Service Blood and Transplant in the United Kingdom.