No abstract

This study provides data on National Blood Service (NBS) red blood cell (RBC, n = 9142), platelet (PLT, n = 4232) and fresh frozen plasma (FFP, n = 3584) recipients independently sampled by monthly quota from 29 representative hospitals over 12 months in 2001-2002. Hospitals were stratified by size according to total yearly RBC issues. Transfusion indications were chosen from diagnostic and procedural codes, and recipients grouped into Epidemiology and Survival of Transfusion Recipients Case-mix Groups (E-CMGs). The main E-CMGs were digestive [19% of RBC recipients; including 5% gastrointestinal (GI) bleeds and 3% colorectal surgery], musculoskeletal (15%; 12% hip and knee replacement), haematology (13%) and obstetrics and gynaecology (10%). Renal failure, fractured neck of femur, cardiac artery by-pass grafting (CABG) and paediatrics, each accounted for 3-4% recipients. FFP recipients: the main E-CMGs were digestive (21% of FFP recipients; including 7% GI bleeds and 3% colorectal surgery), hepatobiliary (15%; 7% liver disease and 2% liver transplant), cardiac (12%) and paediatrics (9%) The renal, paediatrics, vascular and haematology E-CMGs each had 6-7% of recipients. PLT recipients: the main E-CMGs were haematology (27% of PLT recipients; including 9% lymphoma and 8% acute leukaemia), cardiac (17%), paediatrics (13%), hepatobiliary (10%) and digestive (9%). Back-weighting gave national estimates of 433 000 RBC, 57 500 FFP and 41 500 PLT recipients/year in England and North Wales, median age 69, 64 and 59 years, respectively. Digestive and hepatobiliary indications emerged as the top reason for transfusion in RBC and FFP recipients, and was also a frequent indication in PLT recipients.

9 Introduction: The rate of complications after surgery is increased in patients with Sickle Cell Disease (SCD) and pre-operative blood transfusion has historically been used to decrease this risk. Observational studies and one limited Randomised Controlled Trial (RCT) have suggested that in some patients, transfusion can safely be omitted. Since transfusion is associated with complications including alloimmunisation and increased post-operative infections, we performed a RCT to address whether overall peri-operative complications in SCD are reduced by pre-operative transfusion. Methods: TAPS was a Phase III multicentre, pragmatic, randomised controlled trial with a parallel group sequential superiority design, carried out between November 2007 and March 2011 at 22 sites in the UK, Netherlands and Canada. Eligible patients had HbSS or HbSβ°thal, were aged one year or more and were having low risk (eg adenoidectomy, dental surgery) or medium risk (eg joint replacement, cholecystectomy, tonsillectomy) elective surgery. Patients were excluded if they had a haemoglobin (Hb) <6.5g/dl, had received a blood transfusion within the last 3 months or had severe SCD. Patients were randomly assigned to Arm A, which received no pre-operative transfusion, or Arm B, which received a top-up transfusion if Hb<9g/dl or a partial exchange if Hb≥9g/dl. Sites followed their own standards for all other aspects of peri-operative care, although guidance was provided. The primary outcome was all significant complications between randomisation and 30 days post surgery as defined in the protocol. These were sent blinded to the End-Point Review Panel for final classification. Complications which were life-threatening, or resulted in death or persistent or significant incapacity/disability and other important medical events were also recorded as Serious Adverse Events (SAEs) and were reviewed by an Independent Data Monitoring Committee (IDMC). Due to a major imbalance in the number of SAEs between treatment groups, the trial was terminated early following an IDMC recommendation. Results: 333 patients were screened for the trial and 70 patients were randomised at the time the trial was terminated. Thirty three completed 30 day follow up in Arm A and 34 in Arm B. Both groups were comparable with respect to age, gender, severity of SCD, type of surgery and baseline Hb. Only 13 patients had low risk surgery. The pre-operative (post-transfusion) Hb was higher in Arm B (9.7g/dl vs 7.7g/dl) and 5 patients in Arm B received partial exchange transfusion with a mean pre-operative HbS% of 47.2%. There were no differences in peri-operative management, including fluid support and oxygen therapy, between the two groups. There were 11 SAEs (33%) in patients who did not receive a pre-operative transfusion, compared to only 1 SAE (3%) in patients who did receive a top-up transfusion or partial exchange. Eleven of the SAEs were Acute Chest Syndrome (ACS). Patients in the no pre-operative transfusion group also had more significant complications (13/33, 39%), which included SAEs, as compared to patients in the top-up/exchange group (5/34, 15%). Type of surgery: 58% of patients underwent abdominal or ENT surgery. Four out of 13 patients (31%) who had Abdominal surgery in Arm A had ACS events compared to none out of 10 patients in Arm B. Out of the 9 patients who had Tonsillectomy in Arm A, 3 patients had ACS events (33%) compared to none in 7 patients in Arm B. Discussion: This RCT has shown a large increase in SAEs in un-transfused patients with HbSS and HbSβ°thal having low and moderate risk surgery. In particular there was a striking increase in ACS, a potentially life-threatening complication. We therefore recommend that pre-operative transfusion should be strongly considered for patients with HbSS and HbSβ°thal undergoing moderate risk surgery, in particular abdominal surgery and tonsillectomy. There was no evidence of increased benefit of exchange transfusion over top-up, although numbers were small, and exchange transfusions should be reserved for patients with a Hb>9g/dl. There is insufficient evidence to reach a conclusion on the role of pre-operative transfusion in other types of surgery or in patients with other sickle genotypes. Pre-operative transfusion in these patients should be decided on a case by case basis. Acknowledgment: submitted on behalf of the TAPS Trial Investigators. Disclosures: No relevant conflicts of interest to declare.

Previous studies of blood use have used different methods to obtain and classify transfusion indications. Before undertaking a national study of transfusion recipients, a pilot study was performed over 2 months at two teaching and two district general hospitals to match information from hospital transfusion laboratories with clinical coding data from the hospital's Patients Administration System to determine the indication for transfusion in 2468 recipients. Data analysis revealed major limitations in the conventional use of primary diagnostic International Statistical Classification of Disease and Related Health Problems 10th Revision (ICD-10) or procedure Office of Population, Censuses and Surveys - Classification of Surgical Operations and Procedures - 4th Revision (OPCS-4) codes alone in allocating transfusion indications. A novel algorithm was developed, using both types of code, to select the probable indication for transfusion for each patient. A primary OPCS-4 code was selected for recipients transfused in relation to surgery (43%) and either the primary (36%) or the secondary (12%) ICD-10 code was chosen for recipients transfused for medical reasons. The remaining patients were unclassified. Selected codes were then collated into Epidemiology and Survival of Transfusion Recipients (EASTR) casemix groups (E-CMGs). The most frequent E-CMGs were haematology (15% of recipients), musculoskeletal (14%), digestive system (12%) and cardiac (10%). The haematology E-CMG includes patients with malignant and non-malignant blood disorders and recipients transfused for anaemia where no cause was listed. Recipients undergoing hip and knee replacement and coronary artery bypass grafting are within the musculoskeletal and cardiac E-CMGs. The digestive E-CMG includes recipients transfused for gastrointestinal (GI) bleeds and those undergoing GI surgery. This methodology provides a more useful means of establishing the probable indication for transfusion and arranging recipients into clinically relevant groups.