Evidence map›Paper›PMID 27317703›Full record

Trial reportBritish journal of anaesthesia2016

Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): a double-blind phase III study of haemostatic therapy.

N Rahe-Meyer, J H Levy, C D Mazer, A Schramko, A A Klein, R Brat, Y Okita, Y Ueda, D S Schmidt, R Ranganath and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of anaesthesia, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01475669 (REPLACE), which is not on this map. Cited by 44 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 4 pooled it
16.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01475669 phase3completednot on this map

REPLACE (Randomized Evaluation of Fibrinogen Versus Placebo in Complex Cardiovascular Surgery): a Prospective, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study for the Use of Fibrinogen Concentrate (Human) (FCH) in Complex Cardiovascular Surgery

TypeinterventionalSponsorCSL BehringRan2012 to 2014Enrolled152ConditionsSurgical Blood Loss, Postoperative Blood LossArmsFibrinogen Concentrate (Human) (FCH), Placebo
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 4 syntheses or guidelines pooled it, 148 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Does Intraoperative Fibrinogen Affect Blood Loss or Transfusion Practice After Aortic Arch Surgery: A Prematurely Ended Randomized Trial.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Trial
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 10 institutions in 7 countries.

N Rahe-MeyerClinic for Anesthesiology and Intensive Care Medicine, Franziskus Hospital, Kiskerstraße 26, D-33615 Bielefeld, Germany niels.rahe-meyer@franziskus.de.
J H LevyDuke University School of Medicine, Durham, NC, USA.
C D MazerSt Michael's Hospital University of Toronto, Toronto, ON, Canada.
A SchramkoHelsinki University Hospital, Helsinki, Finland.
A A KleinPapworth Hospital, Cambridge, UK.
R BratFaculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
Y OkitaKobe University Hospital, Kobe, Japan.
Y UedaNagoya University Graduate School of Medicine, Nagoya, Japan.
D S SchmidtCSL Behring, Marburg, Germany.
R RanganathCSL Behring, King of Prussia, PA, USA.
R GillUniversity Hospital of Southampton, Southampton, UK.
Behringwerke (Germany) · DECSL (United States) · USDuke University · USHelsinki University Hospital · FIKobe University Hospital · JPNagoya University · JPPapworth Hospital · GBSt. Franziskus Hospital · DESt. Michael's Hospital · CAUniversity of Ostrava · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSingle-dose human fibrinogen concentrate (FCH) might have haemostatic benefits in complex cardiovascular surgery.

methodsPatients undergoing elective aortic surgery requiring cardiopulmonary bypass were randomly assigned to receive FCH or placebo. Study medication was administered to patients with a 5 min bleeding mass of 60-250 g after separation from bypass and surgical haemostasis. A standardized algorithm for allogeneic blood product transfusion was followed if bleeding continued after study medication.

results519 patients from 34 centres were randomized, of whom 152 (29%) met inclusion criteria for study medication. Median (IQR) pretreatment 5 min bleeding mass was 107 (76-138) and 91 (71-112) g in the FCH and placebo groups, respectively (P=0.13). More allogeneic blood product units were administered during the first 24 h after FCH, 5.0 (2.0-11.0), when compared with placebo, 3.0 (0.0-7.0), P=0.026. Fewer patients avoided transfusion in the FCH group (15.4%) compared with placebo (28.4%), P=0.047. The FCH immediately increased plasma fibrinogen concentration and fibrin-based clot strength. Adverse event rates were comparable in each group.

conclusionsHuman fibrinogen concentrate was associated with increased allogeneic blood product transfusion, an unexpected finding contrary to previous studies. Human fibrinogen concentrate may not be effective in this setting when administered according to 5-minute bleeding mass. Low bleeding rates and normal-range plasma fibrinogen concentrations before study medication, and variability in adherence to the complex transfusion algorithm, may have contributed to these results. CLINICAL

trial registrationClinicalTrials.gov identifier no. NCT01475669; EudraCT trial no. 2011-002685-20.

Indexed as

Cardiopulmonary BypassCardiovascular Surgical ProceduresAdultAgedAged, 80 and overBlood TransfusionDouble-Blind MethodFemaleFibrinogenHemorrhageHemostasis, SurgicalHemostaticsHumansMaleMiddle AgedYoung AdultFibrinogenHemostaticsblood, coagulationfibrinogenhaemorrhagesurgery, cardiovascular

Identifiers

PMID27317703
PMCPMC4913420
OpenAlexW2427614983

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.