Preoperative Blood Transfusion May Reduce Perioperative Complications in Patients with Sickle Cell Disease
EBM Focus - Volume 8, Issue 15
The need for surgery is common in patients with sickle cell disease to address both manifestations and complications of the disease, and the rates of surgical complications can be high. Whether preoperative blood transfusions are beneficial in these patients is unclear. One large observational study previously found a decrease in surgical complications with transfusion (Blood 1995 Nov 15;86(10):3676), but others have shown no significant differences. The only previous randomized trial to date compared 2 different transfusion regimens, but now the TAPS trial has compared preoperative transfusion to no transfusion in 67 children and adults with sickle cell disease.
Patients ≥ 1 year old (median age 13 years) with sickle cell disease (hemoglobin SS subtype in 97%) who were having low-risk surgery (e.g. adenoidectomy or inguinal hernia repair) or medium-risk surgery (e.g. cholecystectomy or joint replacement) were randomized to preoperative blood transfusion vs. no transfusion and followed for up to 3 months. Patients having cardiovascular or brain surgery were excluded, as were patients with transfusion within 3 months, acute chest syndrome within 6 months, or history of stroke. The median preoperative hemoglobin levels were 97 g/L (9.7 g/dL) following transfusion in the transfusion group and 77 g/L (7.7 g/dL) in the no transfusion group. The primary outcome was clinically important complications within 30 days of surgery, including infections, sickle cell-related events, transfusion reactions, and cardiovascular events. Life threatening complications and events causing permanent or severe disability were classified as serious adverse events.
Planned enrollment was 405 patients. The trial was terminated early after an unplanned interim analysis of 61 patients indicated a significant decrease in serious adverse events in the transfusion group. In the intention-to-treat population of 67 patients, 3% in the transfusion group and 30% in the no transfusion group had serious adverse events (p = 0.002, NNT 4). The most common adverse event was acute chest syndome. The rates of clinically important complications were 15% with transfusion vs. 39% without transfusion (p = 0.023, NNT 5). There were no significant differences in duration of hospital stay or readmission rates.
For more information, see the Sickle cell disease topic in DynaMed.