Prospective study of preoperative autologous blood donation for patients with high risk of allogeneic blood transfusion in lumbar fusion surgery: a study protocol of a randomised controlled trial

Abstract

IntroductionPreoperative autologous blood donation (PABD) can be used to reduce the exposure of allogeneic blood transfusion in patients undergoing elective surgery. Better blood management to avoid anaemia and reduce allogeneic blood transfusion after spine surgery become increasingly important with development of enhanced recovery after surgery. We present here the design of a randomised controlled trial with three groups to verify the clinical effectiveness of PABD in patients at high risk of transfusion for lumbar fusion surgery and explore the optimal timing of autologous blood donation.Method and analysisPatients (age 18–70 years) who will receive lumbar fusion surgery for degenerative disease with haemoglobin over 110 g/L and ‘high risk’ of allogeneic blood transfusion are eligible, unless they refuse participation or are diagnosed with malignant metastases, infection, cardiovascular and cerebrovascular diseases, haematological disorders or relevant drug history and critical illnesses. A total of 1200 patients will be recruited and randomised into three groups. Patients in group A will not receive PABD and be regarded as control group. PABD will be performed for patients in groups B and C. Blood donation will be finished at 1 week (±3 day) before surgery in group B and 2 weeks (±3 day) before surgery in group C. Primary outcome measures will include haemoglobin decline, incidence and amount of allogeneic blood transfusion. Secondary outcome measures will include days of hospitalisation after surgery, haematocrit level and incidence of complications. This study is a single-centre and open-label randomised controlled trial. The sample size is calculated with reference to the retrospective data and previous studies.Ethics and disseminationThis trial has been approved by the Peking University Third Hospital Medical Science Research Ethic Committee (no: 2020-262-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations.Trial registration numberChiCTR2000039824, preresults.

Clinical prediction model for red cell blood transfusion in elective primary posterior lumbar spine fusion

“…3.) Our model was more accurate than the previous model 3,14,15 for preparing blood resources before elective spinal surgery, with the cost-effectiveness of the blood reserves in limited healthcare systems. 4.)…”

“…Previous studies indicated the substantial effect of intraoperative predictors. 1,3,8,9,[11][12][13][14]16 Another previous study 3 revealed the association of PRC transfusion with age, low BMI, number of fusion and fixation segments, spine deformity, and preoperative Hb level. Further, the type of lumbar spine fusion is associated with variations in intraoperative blood loss, which should be defined.…”

“…Potential clinical predictors include baseline characteristics, such as female sex [8][9][10] , age 8,9 , and BMI 1 ; comorbidities, such as type II diabetes mellitus 8,11 , hypertension 11 , pulmonary disease 3,8,9 , anticoagulant or antiplatelet 8 , ASA classification 1,9,12 ; preoperative laboratory parameters, such as preoperative Hct 8,9 and platelets 14 ; operative data, such as operative time 8,9,[11][12][13] , decompression level and fusion method 1,8,9,[11][12][13] , sacral fusion 12 , number of pedicular screw fixations 3 , use of tranexamic acid 20 , and estimated blood loss (EBL) 14 .…”

“…7 Previous potential predictors associated with the risk of PRC transfusion may guide the general adjustment for the cross-match order, such as female sex [8][9][10] , older age 8,9 , high body mass index (BMI) 1 , pulmonary disease or dyspnea 8,9,11 , bleeding disorders 8 , anticoagulant/antiplatelet therapy 8 , high American Society of Anesthesiologist (ASA) classification 1,9,12 , low preoperative hemoglobin (Hb) levels 11 , hematocrit (Hct) 8,9 , multilevel surgery (laminectomy and fusion) 8,9,[11][12][13] , long surgical time 8,9,[11][12][13] , transforaminal lumbar interbody fusion (TLIF) 1,12 , and sacrum fusion. 12 Recent limited studies 14 revealed that a nanogram for PRC transfusion was not simplified for application, reported only preoperative predictors 15 , and did not define the type of fusion 3 . Intraoperative procedures were strong predictors that affected the accuracy of the prediction model 1,3,8,9,[11][12][13][14]16 , but they were inappropriate in the preoperative prediction model.…”

“…12 Recent limited studies 14 revealed that a nanogram for PRC transfusion was not simplified for application, reported only preoperative predictors 15 , and did not define the type of fusion 3 . Intraoperative procedures were strong predictors that affected the accuracy of the prediction model 1,3,8,9,[11][12][13][14]16 , but they were inappropriate in the preoperative prediction model. Lumbar spine magnetic resonance imaging stimulated preoperative procedure planning in a previous cohort 17 , similar to actual surgery.…”