TRAUMA
Postoperative blood transfusion strategy in frail, anemic elderly patients with hip fracture The TRIFE randomized controlled trial
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by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2015;3(24):40 Acta Orthop. 2015 Jun;86(3):363-72284 elderly patients who underwent surgical hip fracture treatment were randomized to either restrictive or liberal red blood cell (RBC) transfusions within the first 30 postoperative days. The purpose of this study was to determine whether RBC transfusion techniques were associated with clinical outcomes such as increased physical recovery or reduced mortality after surgery. Findings showed that implementation of either restrictive or liberal RBC transfusions resulted in comparable physical recovery, however; liberal RBC transfusions may increase 30day survival.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomization
4/4
Outcome Measurements
3/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Perioperative blood loss is common in hip fracture patients and could lead to acute anemia as defined by <12g/dL and <13g/dL of haemoglobin in women and men, respectively. Anemia in frail elderly patients may be associated with reduced ambulation and functional independence, resulting in an overall worsening performance of activities of daily living. Additionally, elderly hip fracture patients are also at an increased risk of mortality, relative to those without such injuries. There has been increased Interest in improving outcomes and mortality risk in this population, and specifically in whether the method of red blood cell transfusion plays a role. Multiple RCTs have been conducted on this topic, however very few frail elderly patients were included in such studies. Anemia is predicted to be the cause of mortality in this population, therefore, a randomized study with a populace of frail elderly patients with hip fractures to determine optimal Hb transfusion targets was required.
主な研究課題は何ですか？
Does a restrictive versus a liberal red blood cell transfusion strategy correlate with the degree of physical recovery and mortality after hip fracture surgery in frail, elderly patients, as assessed up to 90 days postoperatively?
重要な知見は？
- Nursing home patients (96%) were significantly more frail than sheltered housing residents (78%), assessed at baseline (p<0.001)
- Physical abilities were impaired in patients of both transfusion groups, assessed at 10 postoperative days (p<0.001)
- The Modified Barthel index score showed comparable results between the restrictive and liberal transfusion groups through equal means (p=0.3)
- No significant differences were found between groups in the 30-day (HR: 1.8 [95% CI 0.7, 3.6]; p=0.1) or 90-day (HR: 1.4 [95% CI 0.9, 2.2]; p=0.2) mortality rates in the intention to treat analysis
- Subgroup analysis showed a higher mortality rate among those living in nursing homes in the restrictive strategy group compared to the liberal group (HR: 2.0 [95% CI 1.1, 3.6]; p=0.01)
- Significant differences were seen in Hb measurements between the restrictive transfusion group (mean Hb levels of 11.3 g/dL 95% CI 11.3 to 11.4) and the liberal group (12.2 g/dL 95% CI 12.2 to 12.3, p<0.001)
最も覚えておくべきことは？
Comparable rates of physical recovery were seen in both restrictive and liberal red blood cell transfusion groups for hip fractures in elderly patients. Mortality rates were found to be higher in the restrictive transfusion group compared to the liberal transfusion group at 30-day post-op, as well as in nursing home patients compared to sheltered housing patients when assessed at 90 days post operation.
それが私の患者ケアにどのように影響するか？
Based on the findings of this study, liberal RBC transfusion appears to improve 30-day mortality rate compared to restrictive RBC transfusion, although physical recovery is comparable between the two treatments in frail elderly hip fracture patients. Patients receiving transfusions in a nursing home seem to have a higher mortality rate compared to sheltered homes. Further research should be done to investigate results of liberal RBC transfusion strategy in nursing homes to possibly improve mortality rate.
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