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A restrictive versus liberal transfusion strategy to prevent myocardial injury in patients undergoing surgery for fractured neck of femur: a feasibility randomised trial (RESULT-NOF)
Gillies, M. A., Ghaffar, S., Moppett, I. K., Docherty, A. B., Clarke, S., Rea, N., Stephen, J., Keerie, C., Ray, D. C., White, T. O., et al
British Journal of Anaesthesia. 2021;126(1):77-86
Abstract
BACKGROUND The optimum transfusion strategy in patients with fractured neck of femur is uncertain, particularly if there is coexisting cardiovascular disease. METHODS We conducted a prospective, single-centre, randomised feasibility trial of two transfusion strategies. We randomly assigned patients undergoing surgery for fractured neck of femur to a restrictive (haemoglobin, 70-90 g L(-1)) or liberal (haemoglobin, 90-110 g L(-1)) transfusion strategy throughout their hospitalisation. Feasibility outcomes included: enrolment rate, protocol compliance, difference in haemoglobin, and blood exposure. The primary clinical outcome was myocardial injury using troponin estimations. Secondary outcomes included major adverse cardiac events, postoperative complications, duration of hospitalisation, mortality, and quality of life. RESULTS We enrolled 200 (22%) of 907 eligible patients, and 62 (31%) showed decreased haemoglobin (to 90 g L(-1) or less) and were thus exposed to the intervention. The overall protocol compliance was 81% in the liberal group and 64% in the restrictive group. Haemoglobin concentrations were similar preoperatively and at postoperative day 1 but lower in the restrictive group on day 2 (mean difference [MD], 7.0 g L(-1); 95% confidence interval [CI], 1.6-12.4). Lowest haemoglobin within 30 days/before discharge was lower in the restrictive group (MD, 5.3 g L(-1); 95% CI, 1.7-9.0). Overall, 58% of patients in the restrictive group received no transfusion compared with 4% in the liberal group (difference in proportion, 54.5%; 95% CI, 36.8-72.2). The proportion with the primary clinical outcome was 14/26 (54%, liberal) vs 24/34 (71%, restrictive), and the difference in proportion was -16.7% (95% CI, -41.3 to 7.8; P=0.18). CONCLUSION A clinical trial of two transfusion strategies in hip fracture with a clinically relevant cardiac outcome is feasible. CLINICAL TRIAL REGISTRATION NCT03407573.
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Exploration on the effect of predeposit autotransfusion on bone marrow hematopoiesis after femoral shaft fracture
Li ZZ, Wang H, Jia DL, Wang JH, Jia-Ming X, Li M, Guo JR
Transfusion clinique et biologique : journal de la Societe francaise de transfusion sanguine. 2020
Abstract
OBJECTIVE By observing the changes in the number and activity of CD34+ cells in bone marrow after predeposit autotransfusion (PAT) to patients with femoral shaft fracture (FSF), to evaluate the effects of PAT on hematopoietic function and hematopoietic stem cells in bone marrow. METHODS Selected FSF patients were randomly divided into 2 groups: the control group (patients did not receive blood transfusion after surgery) and PAT group (patients received PAT after surgery). The content of RBC and Plt in blood samples were counted by blood routine. The cell cycle and proportion of CD34+ myelinated cells in blood samples was analyzed by flow cytometry. The telomere DNA length of hematopoietic stem cells (HSCs) in the control groups and PAT group at postoperation 24 was analyzed by southern blot. RESULTS The content of RBC and Plt in postoperation 6h and 24h in the control group was evidently higher compared to that in PAT group, while Hb content in control group was significantly lower compared to that in PAT group. The proportion of CD34+ myelinated cells in post-transfusion 6h and postoperation 24h in PAT group was evidently higher compared to that in the control group. In PAT group, S phase at postoperation 24h was significantly larger compared to that at post-transfusion 6h. The telomere DNA length of HSCs in PAT group was longer than that in the control group. CONCLUSION PAT can increase the number of HSC, while doesn't cause the abnormal aging of HSCs. PAT is suitable for postoperative blood transfusion of patients with FSF.
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Blood transfusion strategy and risk of postoperative delirium in nursing homes residents with hip fracture. A post hoc analysis based on the TRIFE randomized controlled trial
Blandfort S, Gregersen M, Borris LC, Damsgaard EM
Aging Clinical and Experimental Research. 2016;29((3):):459-466
Abstract
OBJECTIVES To investigate whether a liberal blood transfusion strategy [Hb levels ≥11.3 g/dL (7 mmol/L)] reduces the risk of postoperative delirium (POD) on day 10, among nursing home residents with hip fracture, compared to a restrictive transfusion strategy [Hb levels ≥9.7 g/dL (6 mmol/L)]. Furthermore, to investigate whether POD influences mortality within 90 days after hip surgery. METHODS This is a post hoc analysis based on The TRIFE - a randomized controlled trial. Frail anemic patients from the Orthopedic Surgical Ward at Aarhus University Hospital were enrolled consecutively between January 18, 2010 and June 6, 2013. These patients (aged ≥65 years) had been admitted from nursing homes for unilateral hip fracture surgery. After surgery, 179 patients were included in this study. On the first day of hospitalization, all enrolled patients were examined for cognitive impairment (assessed by MMSE) and delirium (assessed by CAM). Delirium was also assessed on the tenth postoperative day. RESULTS The prevalence of delirium was 10 % in patients allocated to a liberal blood transfusion strategy (LB) and 21 % in the group with a restrictive blood transfusion strategy (RB). LB prevents development of delirium on day 10, compared to RB, odds ratio 0.41 (95 % CI 0.17-0.96), p = 0.04. Development of POD on day 10 increased the risk of 90-day death, hazard ratio 3.14 (95 % CI 1.72-5.78), p < 0.001. CONCLUSION In nursing home residents undergoing surgery for hip fracture, maintaining hemoglobin level above 11.3 g/dL reduces the rate of POD on day 10 compared to a RB. Development of POD is associated with increased mortality.
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Postoperative red blood cell transfusion strategy in frail anemic elderly with hip fracture. A randomized controlled trial
Gregersen, M.
Danish Medical Journal. 2016;63((4))
Abstract
Hip fracture in the elderly is associated with poor recovery from physical disability and mortality. Perioperative blood loss is common, and anemia might be fatal in the frail elderly. Red blood cell transfusions might increase the risk of infection. In an observational study, a liberal transfusion strategy with hemoglobin (Hb) target of 7 mmol/l (11.3 g/dl) seemed to improve survival in nursing home residents with hip fracture compared to the recommended restrictive strategy with a Hb target of 6 mmol/l (9.7 g/dl) according to the Danish Health Authority. Our aim was to compare these two strategies in the frail elderly in a randomized controlled trial on the outcomes: recovery from physical disabilities, mortality, infection, infection biomarkers, and overall Quality of Life (OQoL). We included 284 elderly admitted to hospital for surgical hip fracture repair from nursing homes or sheltered housing facilities. The anemic patients were assigned postoperatively to the liberal or the restrictive transfusion strategy. Randomization divided each transfusion group into two equal blocks with regard to type of the residence. Hb was measured daily during the first three postoperative days, at least once during the following 4-6 days, then at least once a week during the subsequent three weeks. The transfusions were administered according to group assignments, but no later than 24 hours after the Hb determination, one unit at a time, and no more than two units per day. The intervention lasted for 30 days after surgery. Outcome measurements were performed on days 10, 30, 90, and 365. Blinded assessors evaluated physical performance and OQoL. The liberal transfusion strategy did not improve recovery from physical disabilities, mortality, infection rate, or OQoL compared to the restrictive strategy. However, in nursing home residents, 90-day mortality rate (20%) following the liberal strategy was statistically significantly lower than that (36%) after the restrictive strategy. Per protocol, the 30-day mortality rate was statistically significantly lower following the liberal strategy in all patients (7% versus 16%). No statistically significant difference was found in repeated leukocyte counts and C-reactive protein measurements, or in rate of all infections after ten days (66% versus 72%). Physical recovery from 30 days until one year after hip fracture surgery was improved by the liberal strategy. A liberal strategy did not improve 30-day OQoL. Physical performance was improved from 30 days to one year after fracture in patients treated according to the liberal strategy and was associated with better progress of OQoL in the same period. We conclude that according to our used Hb thresholds, the liberal Hb target of 7 mmol/l (11.3 g/dl) improves survival in the frailest elderly (the nursing home residents) without impairing recovery from physical disabilities and OQoL or increasing risk of infections compared to the restrictive Hb target of 6 mmol/l (9.7 g/dl). The liberal strategy seems to improve recovery of physical performance within one year after hip fracture surgery which was associated with better overall QoL.
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Effects of positive suggestions on the need for red blood cell transfusion in orthopedic surgery
Szeverenyi C, Csernatony Z, Balogh A, Simon T, Varga K
The International Journal of Clinical and Experimental Hypnosis. 2016;64((4)):404-18.
Abstract
This study examined whether positive suggestions applied without a hypnotic induction in the perioperative period reduces the need for red blood cell transfusions in patients who underwent total hip or knee arthroplasties with spinal anesthesia. No hypnotic assessment was performed. Ninety-five patients were randomly assigned to the suggestion group (n = 45) and to the control group (n = 50). Patients in the suggestion group received verbal suggestions before and audiotaped suggestions during the surgery for reducing blood loss, anxiety, postoperative pain, and fast recovery. Our study showed that using positive suggestions in the perioperative period significantly decreases the necessity for transfusion.
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The effects of blood transfusion on delirium incidence
van der Zanden V, Beishuizen SJ, Scholtens RM, de Jonghe A, de Rooij SE, van Munster BC
Journal of the American Medical Directors Association. 2016;17((8):):748-53
Abstract
BACKGROUND Both anemia and blood transfusion could be precipitating factors for delirium; hence in postoperative patients with anemia at high risk for delirium, it is controversial whether transfusion is the best option. The aim of this study is to investigate the association of anemia and delirium and the role of blood transfusion within the multicomponent prevention strategy of delirium. METHODS We conducted a substudy of a multicenter randomized controlled trial. Four hundred fifteen patients aged 65 to 102 years old admitted for hip fracture surgery were enrolled. Delirium was assessed daily using criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. Data on hemoglobin values and transfusion were collected from the electronic medical records. RESULTS One hundred fifteen (32.5%) patients experienced delirium during hospitalization, 238 (57.5%) had a hemoglobin level ≤ 6.0 mmol/L (9.7 g/dL) at any time during hospitalization, and 140 (33.7%) received a blood transfusion. Anemia (a hemoglobin level ≤ 6.0 mmol/L [9.7 g/dL]) was associated with delirium (odds ratio, 1.81; 95% confidence interval, 1.15-2.86). Blood transfusion was a protective factor for delirium in patients with the lowest measured hemoglobin level ≤ 6.0 mmol/L (9.7 g/dL) (odds ratio, 0.26; 95% confidence interval, 0.10-0.70). CONCLUSION Low hemoglobin level is associated with delirium, and receiving a blood transfusion is associated with a lower delirium incidence. It would be interesting to investigate the effect of blood transfusion as part of the multicomponent treatment of delirium in patients with anemia.
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Long-term mortality in the transfusion trigger trial for functional outcomes in cardiovascular patients undergoing surgical hip fracture repair (FOCUS)
Carson LJ
Transfusion Medicine. 2015;25((Suppl. 1)):7.. Abstract No. S12
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Blood transfusion and overall quality of life after hip fracture in frail elderly patients - the Transfusion Requirements in Frail Elderly randomized controlled trial
Gregersen M, Borris LC, Damsgaard EM
Journal of the American Medical Directors Association. 2015;16((9)):762-6.
Abstract
BACKGROUND We examined possible associations between different red blood cell (RBC) transfusion strategies, overall quality of life (OQoL), and recovery of activities of daily living (ADL) in operated frail elderly hip fracture patients, and the possibility that OQoL was related to ADL recovery. METHODS A prospective, assessor-blinded, randomized controlled trial was carried out among 157 elderly residents (>65 years) from nursing homes and sheltered housing facilities with Mini-Mental State Examination scores >5 points. Patients were assigned to either a restrictive RBC transfusion strategy [hemoglobin (Hb) < 9.7 g/dL, 6 mmol/L] or a liberal strategy (Hb < 11.3 g/dL, 7 mmol/L) during the first 30 days after surgery. An interview-based questionnaire, the depression list (DL) assessing OQoL, and the modified Barthel Index (MBI) assessing ADL performance, were conducted on day 30 and 1 year after hip fracture surgery. Sum-scores of DL, MBI, and their changes from day 30 until 1 year (expressing recovery) were compared between RBC transfusion groups. Possible associations between changes of DL and MBI sum-scores were tested for across total patient population. RESULTS There was no association between OQoL and RBC transfusion strategies on day 30 or at 1 year. The DL sum-score changes were similar for both groups, (ie, 1.06 points) [95% confidence interval (CI) -0.62, 2.76)] P = .21. The MBI sum-scores increased at 1 year following the liberal transfusion strategy (ie, by 6.86 points) (95% CI 0.41, 13.3) P = .03. Recoveries of OQoL and ADL were associated: beta = -0.06 (95% CI -0.11, -0.01) P = .02. CONCLUSIONS According to our Hb threshold criteria, OQoL and RBC transfusion strategies for frail elderly hip fracture patients are not associated. However, for survivors with less severe dementia, ADL recovery after 1 year is greater following a liberal transfusion strategy than a restrictive strategy. OQoL progress and ADL recovery were associated.Copyright © 2015 AMDA - The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.
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Postoperative blood transfusion strategy in frail, anemic elderly patients with hip fracture
Gregersen M, Borris LC, Damsgaard EM
Acta Orthopaedica. 2015;86((3)):363-72.
Abstract
Background and purpose - Hip fracture (HF) in frail elderly patients is associated with poor physical recovery and death. There is often postoperative blood loss and the hemoglobin (Hb) threshold for red blood cell (RBC) transfusions in these patients is unknown. We investigated whether RBC transfusion strategies were associated with the degree of physical recovery or with reduced mortality after HF surgery. Patients and methods - We enrolled 284 consecutive post-surgical HF patients (aged > 65 years) with Hb levels < 11.3 g/dL (7 mmol/L) who had been admitted from nursing homes or sheltered housing. Allocation was stratified by residence. The patients were randomly assigned to either restrictive (Hb < 9.7 g/dL; < 6 mmol/L) or liberal (Hb < 11.3 g/dL; < 7 mmol/L) RBC transfusions given within the first 30 days postoperatively. Follow-up was at 90 days. Results - No statistically significant differences were found in repeated measures of daily living activities or in 90-day mortality rate between the restrictive group (where 27% died) and the liberal group (where 21% died). Per-protocol 30-day mortality was higher with the restrictive strategy (hazard ratio (HR) = 2.4, 95% CI: 1.1-5.2; p = 0.03). The 90-day mortality rate was higher for nursing home residents in the restrictive transfusion group (36%) than for those in the liberal group (20%) (HR = 2.0, 95% CI: 1.1-3.6; p = 0.01). Interpretation - According to our Hb thresholds, recovery from physical disabilities in frail elderly hip fracture patients was similar after a restrictive RBC transfusion strategy and after a liberal strategy. Implementation of a liberal RBC transfusion strategy in nursing home residents has the potential to increase survival.
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Blood transfusion and risk of infection in frail elderly after hip fracture surgery: the TRIFE randomized controlled trial
Gregersen M, Damsgaard EM, Borris LC
European journal of orthopaedic surgery & traumatologie. 2015;25((6)):1031-8.
Abstract
OBJECTIVES It is still under debate that red blood cell (RBC) transfusions might increase the risk of healthcare-associated infections after hip fracture surgery. Previously, we found that a liberal RBC transfusion strategy improved survival in nursing home residents. Our aim, therefore, was to investigate whether a more liberal RBC transfusion strategy was associated with a higher infection risk in frail elderly hip fracture patients. DESIGN Prospective, assessor-blinded, randomized and controlled trial. SETTINGS Orthopedic ward, Geriatric ward, and Hospital-at-home. PATIENTS 284 consecutively hospital-admitted elderly with hip fracture from nursing homes or sheltered housing facilities were included. INTERVENTION A restrictive RBC transfusion strategy (hemoglobin <9.7 g/dL; 6 mmol/L) compared with a liberal strategy (hemoglobin <11.3 g/dL; 7 mmol/L) administered within 30 days after surgery. MAIN OUTCOME MEASUREMENTS Leukocytes and C-reactive protein (CRP) in repeated blood samples within 30 days, and number of all infections (pneumonia, urinary tract infection, and other infections) within 10 days. RESULTS 88 % of the patients received a RBC transfusion. A median of 1 RBC unit (interquartile range (IQR): 1-2) was transfused for the restrictive strategy group versus 3 RBC units (IQR: 2-5) for the liberal group. Leukocytes and CRP measurements were similar for both groups. Rates of infection were 72 % for the restrictive group compared to 66 % for the liberal group (risk ratio 1.08; 95 % confidence interval 0.93-1.27, p value 0.29). CONCLUSIONS A more liberal RBC transfusion strategy was not associated with higher risk of infection among residents from nursing homes or sheltered housing undergoing hip fracture surgery.