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Meta-Analysis
. 2015 Jul 14;2015(7):CD007614.
doi: 10.1002/14651858.CD007614.pub2.

Fresh frozen plasma for cardiovascular surgery

Michael Desborough  1 , Ravinda Sandu, Susan J Brunskill, Carolyn Doree, Marialena Trivella, Alessandro Montedori, Iosief Abraha, Simon Stanworth
Affiliations
Meta-Analysis

Fresh frozen plasma for cardiovascular surgery

Michael Desborough et al. Cochrane Database Syst Rev. .

Abstract

Background: Fresh frozen plasma (FFP) is a blood component containing procoagulant factors, which is sometimes used in cardiovascular surgery with the aim of reducing the risk of bleeding. The purpose of this review is to assess the risk of mortality for patients undergoing cardiovascular surgery who receive FFP.

Objectives: To evaluate the risk to benefit ratio of FFP transfusion in cardiovascular surgery for the treatment of bleeding patients or for prophylaxis against bleeding.

Search methods: We searched 11 bibliographic databases and four ongoing trials databases including the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, 2015), MEDLINE (OvidSP, 1946 to 21 April 2015), EMBASE (OvidSP, 1974 to 21 April 2015), PubMed (e-publications only: searched 21 April 2015), ClinicalTrials.gov, World Health Organization (WHO) ICTRP and the ISRCTN Register (searched 21 April 2015). We also searched the references of all identified trials and relevant review articles. We did not limit the searches by language or publication status.

Selection criteria: We included randomised controlled trials in patients undergoing major cardiac or vascular surgery who were allocated to a FFP group or a comparator (no plasma or an active comparator, either clinical plasma (any type) or a plasma-derived blood product). We included participants of any age (neonates, children and adults). We excluded studies of plasmapheresis and plasma exchange.

Data collection and analysis: Two authors screened all electronically derived citations and abstracts of papers identified by the review search strategy. Two authors assessed risk of bias in the included studies and extracted data independently. We took care to note whether FFP was used therapeutically or prophylactically within each trial.

Main results: We included 15 trials, with a total of 755 participants for analysis in the review. Fourteen trials compared prophylactic use of FFP against no FFP. One study compared therapeutic use of two types of plasma. The timing of intervention varied, including FFP transfusion at the time of heparin neutralisation and stopping cardiopulmonary bypass (CPB) (seven trials), with CPB priming (four trials), after anaesthesia induction (one trial) and postoperatively (two trials). Twelve trials excluded patients having emergency surgery and nine excluded patients with coagulopathies.Overall the trials were small, with only four reporting an a priori sample size calculation. No trial was powered to determine changes in mortality as a primary outcome. There was either high risk of bias, or unclear risk, in the majority of trials included in this review.There was no difference in the number of deaths between the intervention arms in the six trials (with 287 patients) reporting mortality (very low quality evidence). There was also no difference in blood loss in the first 24 hours for neonatal/paediatric patients (four trials with 138 patients; low quality evidence): mean difference (MD) -1.46 ml/kg (95% confidence interval (CI) -4.7 to 1.78 ml/kg); or adult patients (one trial with 120 patients): MD -12.00 ml (95% CI -101.16 to 77.16 ml).Transfusion with FFP was inferior to control for preventing patients receiving any red cell transfusion: Peto odds ratio (OR) 2.57 (95% CI 1.30 to 5.08; moderate quality evidence). There was a difference in prothrombin time within two hours of FFP transfusion in eight trials (with 210 patients; moderate quality evidence) favouring the FFP arm: MD -0.71 seconds (95% CI -1.28 to -0.13 seconds). There was no difference in the risk of returning to theatre for reoperation (eight trials with 398 patients; moderate quality evidence): Peto OR 0.81 (95% CI 0.26 to 2.57). Only one included study reported adverse events as an outcome and reported no significant adverse events following FFP transfusion.

Authors' conclusions: This review has found no evidence to support the prophylactic administration of FFP to patients without coagulopathy undergoing elective cardiac surgery. There was insufficient evidence about treatment of patients with coagulopathies or those who are undergoing emergency surgery. There were no reported adverse events attributable to FFP transfusion, although there was a significant increase in the number of patients requiring red cell transfusion who were randomised to FFP. Variability in outcome reporting between trials precluded meta-analysis for many outcomes across all trials, and there was evidence of a high risk of bias in most of the studies. Further adequately powered studies of FFP, or comparable pro-haemostatic agents, are required to assess whether larger reductions in prothrombin time translate into clinical benefits. Overall the evidence from randomised controlled trials for the safety and efficacy of prophylactic transfusion of FFP for cardiac surgery is insufficient.

PubMed Disclaimer

Conflict of interest statement

MD: None known.

RS: None known.

SB: None known.

CD: None known.

MT: My role as a statistical editor/referee for 4 Cochrane groups (Anaesthesia, Wounds, Breast Cancer, and Sexually Transmitted Infections), and previous editorial work with the Injuries Group, are independent to my involvement in this review. I declare that my involvement here as an author has no related financial relationships.

AM: None known.

IA: None known.

SS: None known.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' summary: authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 1: Short‐term mortality (up to 30 days)
1.2
1.2. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 2: Serious organ damage ‐ myocardial infarction
1.3
1.3. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 3: Serious organ damage ‐ renal failure
1.4
1.4. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 4: Bleeding in first 24 hours (adults ‐ ml; neonates and paediatrics ml/kg)
1.5
1.5. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 5: Transfusion requirements (volume) – red cells (up to 24 hours) (adults ‐ ml; neonates and paediatrics ml/kg)
1.6
1.6. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 6: Number of patients receiving a red cell transfusion
1.7
1.7. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 7: Transfusion requirements – platelets (up to 24 hours) (units)
1.8
1.8. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 8: Transfusion requirements – cryoprecipitate (up to 24 hours) (units)
1.9
1.9. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 9: Measurement of prothrombin time within 2 hours of FFP or control infusion
1.10
1.10. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 10: Measurement of activated partial thromboplastin time within 2 hours of FFP or control infusion
1.11
1.11. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 11: Measurement of fibrinogen concentration within 2 hours of FFP or control infusion
1.12
1.12. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 12: Resource use: time in intensive care unit
1.13
1.13. Analysis
Comparison 1: Fresh frozen plasma versus no plasma, Outcome 13: Resource use: need for return to theatre
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD007614

References

References to studies included in this review

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References to studies awaiting assessment

Miao 2014 {published data only}
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