[Summary text]
See Fominskiy 2015
Fominskiy, E., et al. "Liberal transfusion strategy improves survival in perioperative but not in critically ill patients. A meta-analysis of randomised trials." BJA: British Journal of Anaesthesia 115.4 (2015): 511-519.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: Patients admitted from nursing homes for unilateral hip fracture surgery, with postoperative Hb between 9.7 and 11.3 g/dl, on at least one of the first six postoperative.
Excluded criteria: Active cancer; pathological fractures and inability to understand or speak danish, refusal of RBC transfusion, fluid overload, irregular erythrocyte antibodies or previous enrolement in the trial
Pretreatment: The two groups were well-balanced
Intervention Characteristics
Intervention 1
Control
Infection (pneumonia or wound infection)
Country: Denmark
Comments: Study based on the TRIFE trial
Authors name: Sif Blandfort
Institution: Departments of Geriatrics, Aarhus University Hospital, Aarhus C., Denmark
Email: sifbland@rm.dk
Address: Dep. of Geriatrics, Aarhus University Hospital. Ørumsgade 11, 8000 Aarhus
Randomised clinical trial
Adult participants who underwent a major surgical procedure for abdominal cancer and required postoperative care in the ICU • Liberal: n = 97; mean age (SD) = 64 (14) years • Restrictive: n = 101; mean age (SD) = 64 (12) years
While in the ICU, the liberal transfusion group received transfusion when Hg
The primary outcome was a composite of all-cause mortality or severe clinical complications within 30 days. Severe clinical complications included major cardiovascular complications, septic shock, acute kidney injury requiring renal replacement therapy, ARDS, and reoperation
See Carson et al 2012
Carson, Jeffrey L., Paul A. Carless, and Paul C. Hebert. "Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion." Cochrane Database Syst Rev. 4.1 (2012).
Randomised clinical trial
Participants with septic shock and haemoglobin concentration less than 9 g/dL • Higher threshold: n = 496; age (interquartile range) = 67 (58 to 75) years • Lower threshold: n = 502; age (interquartile range) = 67 (57 to 73) years
The intervention was single units of cross-matched, prestorage leukoreduced RBCs when the blood concentration of haemoglobin had decreased to the assigned transfusion threshold (≤ 7 g/dL (lower threshold) or ≤ 9 g/dL (higher threshold)). The intervention period was the entire ICU stay, to a maximum of 90 days after randomisation
The primary outcome was 90-day mortality.
Randomised clinical trial
Participants were at least 18 years of age and scheduled for elective hip revision surgery • Liberal: n = 33; median age (5% to 95% range) = 72 (54 to 89) years • Restrictive: n = 33; median age (5% to 95% range) = 68 (43 to 86) years
The participants were randomized to a restrictive strategy receiving transfusion of RBC at a Hb of 7.3 g/dL (4.5 mmol/L) or a liberal strategy receiving transfusion of RBC at a Hb of 8.9 g/dL (5.5 mmol/L). The target level of haemoglobin in the restrictive group was 7.3 g/dL to 8.9 g/dL and above 8.9 g/dL in the liberal group
The primary outcome was the ’Timed up and go’ test. Other outcomes were pneumonia, wound infection, gastrointestinal complications, dizziness, hypotension, fatigue, deep vein thrombosis, and fall
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: All patients admitted to a participating center were screenedfor enrollment. Patients were approached for enrollment if they wereadmitted to a participating burn center within 96 hours of injury witha burn injury of 20% or higher TBSA and need for burn excision andgrafting was anticipated.
Excluded criteria: 18 years old; pregnant; unable or unwilling to receive blood products; chronically anemic; renal dialysis before injury; brain dead; insurvivable burn; acute AMI; preexsisting hematologica disorder; head injury with GSC 9.
Pretreatment: The groups were comparable
Intervention Characteristics
Intervention 1
Control
30-days mortality, n
Mean no. of units transfused, SD
No. of patients that received transfusion, n
Infection (pneumonia or wound infection)
Sponsorship source: This study was supported by the American Burn Association and funded byUSAMRMC Award W81XWH-08-1-0760 with support from the NationalCenter for Research Resources, National Institutes of Health, through grantUL1 RR024146, the National Center for Advancing Translational Sciences,National Institutes of Health, through grant TR 000002, and the NationalCenter for Advancing Translational Sciences, National Institutes of Healththrough grant UL1 TR001860.
Country: USA
Setting: Multicenter
Comments: Clinicaltrials.gov NCT01079247
Authors name: Tina L. Palmieri
Institution: Department of Surgery, University of California Davis and Shriners Hospital for Children Northern California
Email: tlpalmieri@ucdavis.edu
Address: Dep. of surgery, University California. Davis and Shriners Hospital for Children Nothern California, 2425 Stockton Blvd Suite 718
Randomised clinical trial
Participants 60 years of age or older with hip fracture and whose postoperative haemoglobin level on postoperative days 1 or 2 was between 8.0 g/dL to 9.5 g/dL • Liberal: n = 100; mean age (range) = 84.4 (60 to 104) years • Symptomatic: n = 100; mean age (range) = 84.2 (60 to 97) years
Liberal transfusion maintained haemoglobin > 10.0 g/dL, or the symptomatic group received transfusion for symptoms of anaemia. These included recurrent vaso-vagal episodes on mobilisation, chest pain of cardiac origin, congestive cardiac failure, unexplained tachycardia, hypotension or dyspnoea that was felt to be due to anaemia, decreased urine output that is unresponsive to fluid replacement, or symptoms felt appropriate by the medical staff
Mobility, mental agility, physical status using the American Society of Anesthesiologists grade
Randomised controlled trial, not blinded
Postpartum haemorrhage (blood loss of ≥1000 ml or a decrease in Hb concentration of ≥1.9 g/dL, or both) and had an Hb between 4.8 g/dL and 7.9 g/dL 12 to 24 hours after delivery • Liberal: n = 258; mean age (SD) = 30.7 (5.0) years • Non-intervention: n = 261; mean age (SD) = 30.9 (5.3) years
In the liberal group, participants received at least 1 unit of red blood cells; the trialists aimed to reach an Hb concentration of at least 8.9 g/dL. In the restrictive group, participants received no transfusion
Primary outcome was physical fatigue 3 days postpartum using the Multidimensional Fatigue Inventory scale
See Fominskiy 2015
Fominskiy, E., et al. "Liberal transfusion strategy improves survival in perioperative but not in critically ill patients. A meta-analysis of randomised trials." BJA: British Journal of Anaesthesia 115.4 (2015): 511-519.
Randomised clinical trial
Elective orthopedic surgery • Liberal: n = 304; mean age (SD) = 70.7 (9.6) years • Restrictive: n = 299; mean age (SD) = 70.2 (10.3) years
Restrictive transfusion was compared with liberal transfusion regimens
The primary outcome variable was RBC use. Secondary outcomes included postoperative complications and quality of life
We re-analysed the prior report (So-Osman 2010) comparing restrictive versus liberal transfusion
Randomised clinical trial
Participants older than 18 years of age who had haematemesis or melena, or both (due to upper GI bleeding)
The restrictive transfusion group was transfused for haemoglobin < 7 g/dL, and the liberal transfusion group was transfused when Hg was < 9 g/dL. In both groups, 1 unit of RBCs was transfused initially.
Death at 45 days
Randomised clinical trial
See Carson 2016
The restrictive transfusion group received transfusion with haemoglobin≤ 7.0g/dL and a target Hb concentration of 7.1 g/dL to 9.0g/dL, and the liberal transfusion group received transfusions with haemoglobin ≤ 9.0 g/dL and a target of 9.1 g/dL to 11.0 g/ dL during intervention
The primary feasibility outcome was the difference in mean Hb among groups. Clinical outcomes were assessed
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Only an abstract
Judgement Comment: Central computer program.
See Carson et al 2012
A centralised computer generated the assignment sequence
A dedicated computer program (Idefix) was used after entering participants’ baseline data. The allocation was written on a form, which was kept in the investigator’s office, and the allocation could only be accessed by the investigator in charge of administrating red blood cells
Judgement Comment: Each subject was randomised with a bias coin procedue.
The random sequence generation was not documented.
The use of random sequence generation was not stated
See Fominskiy 2015
The trial provided a detailed description of statistical procedures
Random sequence generation was computer generated.
Minimisation by centre and the presence of IHD, including a random element, was used
The chief statistician ensured random sequence generation
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Only an abstract
Judgement Comment: Randomization was passed on to the hospital staff
See Carson et al 2012
Use of a centralised computer ensured allocation concealment
Only 1 investigator had access to the programme. Investigators at the other hospital had to call this investigator to randomise
Judgement Comment: Open-label trial
The trial used opaque numbered envelopes
The trial used a web-based application with block randomisation of variable block size
See Fominskiy 2015
A research nurse opened sealed opaque envelopes.
The trial used sealed consecutively numbered, opaque envelopes.
The trial used telephone randomisation
The trial used opaque envelopes that were opened sequentially
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Only an abstract
Judgement Comment: Personel was not blinded. Participants were blinded.
See Carson et al 2012
Clinicians were not blinded.
The allocation and Hb during the testing period were concealed from the participants but the investigator, the staff in the operating room, and the staff at the ward could not be blinded
Judgement Comment: No blinding provided. Investigators were informed of treatment group by calling the randomization center
Blinding of participants and personnel was not addressed
Participants were not blinded
See Fominskiy 2015
Clinicians caring for the participants were aware of allocation status. There was no blinding information on participants
Clinicians and participants were not blinded.
Clinicians were not blinded. Most surviving participants stated that they were unaware of group allocation at 180 days (restrictive group: 67%; liberal group: 78%); 23% of participants in the restrictive group and 9% in the liberal group correctly stated their treatment group
Clinicians or participants were not blinded
Detection bias due to knowledge of the allocated interventions by outcome assessors
Only an abstract
Judgement Comment: Outcome assessors were blinded
See Carson et al 2012
The investigators assessing mortality (the DSMB) and the trial statistician were blinded
The physiotherapist testing the participant was blinded, but it was not stated who reviewed medical records for other outcomes
Judgement Comment: Investigators were informed of treatment group by calling the randomization center. No blinding provided.
Blinding of outcome assessment was not addressed.
The primary outcome was based on a questionnaire
See Fominskiy 2015
The trial did not state who collected outcome dat
Mortality was the primary outcome. Assessors of other outcomes were not documented to be blinded
Researchers concealed from group allocation collected questionnaire-based measures at 60 and 180 days postrandomisation. Assessment of clinical outcomes was not documented to have been done blindly
The participants and the study investigators who classified outcomes and those who conducted the follow-up telephone assessments were blinded to the study-group assignments and had no access to transfusion data
Attrition bias due to amount, nature or handling of incomplete outcome data
Only an abstract
Judgement Comment: Dropouts are accounted for
See Carson et al 2012
There was near-complete follow-up
No attrition bias was apparent
Judgement Comment: lost to follow-up was described sufficiently
The mobility score was missing for 94 of 200 participants.
20% of data for the primary outcome was missing
See Fominskiy 2015
No attrition bias was apparent
The trial had good follow up.
There was good follow up.
No attrition bias was apparent.
Reporting bias due to selective outcome reporting
Only an abstract
Judgement Comment: No other apparent sources of bias
See Carson et al 2012
Reporting was comprehensive.
No reporting bias was apparent
Judgement Comment: Matches study protocol
No reporting bias was apparent.
No reporting bias was apparent.
See Fominskiy 2015
No reporting bias was apparent
Reporting was complete.
No reporting bias was apparent
No reporting bias was apparent
Bias due to problems not covered elsewhere in the table
Only an abstract
Judgement Comment: No other apparent sources of bias
See Carson et al 2012
There were no other biases
No other bias was apparent
Judgement Comment: No other apparent sources of bias
No other biases were apparent.
No other biases were apparent.
See Fominskiy 2015
No other biases were apparent
No other biases were apparent.
No other biases were apparent.
No other biases identified