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Volume:3 Issue:12 Number:48 ISSN#:2563-5476
Author Verified
RCT
ACE Report #7928

Higher survival & similar recovery in liberal vs restrictive transfusion in hip fractures


Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:N/A

Postoperative blood transfusion strategy in frail, anemic elderly patients with hip fracture The TRIFE randomized controlled trial

Acta Orthop. 2015 Jun;86(3):363-72

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Synopsis

284 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.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
The Helga and Peter Korning Foundation, and the Department of Geriatrics, Aarhus University Hospital
Conflicts:
None disclosed

Risk of Bias

8/10

Reporting Criteria

19/20

Fragility Index

N/A

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)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

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

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

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.

What was the principal research question?

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?

Study Characteristics -
Population:
284 elderly patients (at or above the age of 65) with unilateral hip fractures and postoperative haemoglobin (Hb) levels between 9.7 g/dL (6 mmol/L) and 11.3 g/dL (7 mmol/L) during the first 6 postoperative days were included in this study from January 18, 2010 - June 6, 2013. All participants resided in either nursing homes or sheltered housing facilities. (260 completed)
Intervention:
Restrictive transfusion group: Patients in this group were randomized to RBC transfusion of Hb<9.7 g/dL; 6 mmol/L (n=144; 132 completed; Mean age: 86 +/- 6.8; 108F/36M)
Comparison:
Liberal transfusion group: Patients of this group were randomized to RBC transfusion of Hb<11.3 g/dL; 7 mmol/L (n= 140; 128 completed; Mean age: 88 +/- 6.9; 106F/34M)
Outcomes:
The primary outcome of this study was recovery of function measured by the Modified Barthel index assessing activities of daily life; New Mobility score assessing indoor and outdoor walking abilities and ability to go shopping; and cumulated ambulation score assessing getting in and out of bed, sitting-to-standing-to-sitting, and walking ability with appropriate aid. Mini-mental state examination (MMSE) was used to assess cognitive status on a scale from 0 to 30, with 30 equaling no cognitive impairment. Secondary outcomes were 30- and 90-day m
Methods:
RCT; prospective, double-blinded; single-center
Time:
Outcomes were assessed at 10, 30 and 90 days postoperative.

What were the important findings?

  • 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)

What should I remember most?

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.

How will this affect the care of my patients?

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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