Evidence map›Paper›PMID 22196464›Full record

Trial reportTrials2011

Transfusion of fresh frozen plasma in non-bleeding ICU patients--TOPIC trial: study protocol for a randomized controlled trial.

Marcella C A Müller, Evert de Jonge, M Sesmu Arbous, Angelique M E Spoelstra-de Man, Atilla Karakus, Margreeth B Vroom, Nicole P Juffermans

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01143909 (Transfusion of Fresh Frozen Plasma in Non-bleeding ICU Patients), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 26% 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.

NCT01143909 nacompletednot on this map

Transfusion of Fresh Frozen Plasma in Non-bleeding ICU Patients

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2010 to 2013Enrolled81ConditionsBlood Coagulation Disorders, HemorrhageArmsomitting FFP transfusion before an intervention
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Plasma transfusion strategies for critically ill patients.The Cochrane database of systematic reviews · 2013
    Pooled it
  3. Trial
  4. Article
  5. Approach to the Coagulopathic Patient in the Intensive Care Unit.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2019
    Article
  6. Review
  7. SDH with Bleeding Diathesis-a Management Protocol.The Indian journal of surgery · 2016
    Article
  8. Pulmonary complications of transfused blood components.Critical care nursing clinics of North America · 2012
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Marcella C A MüllerDepartment of Intensive Care Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. m.c.muller@amc.uva.nl
Evert de Jonge
M Sesmu Arbous
Angelique M E Spoelstra-de Man
Atilla Karakus
Margreeth B Vroom
Nicole P Juffermans
Leiden University Medical Center · NLUniversity of Amsterdam · NLAcademic Medical Center · NLDiakonessenhuis hospital · NLTergooi · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFresh frozen plasma (FFP) is an effective therapy to correct for a deficiency of multiple coagulation factors during bleeding. In past years, use of FFP has increased, in particular in patients on the Intensive Care Unit (ICU), and has expanded to include prophylactic use in patients with a coagulopathy prior to undergoing an invasive procedure. Retrospective studies suggest that prophylactic use of FFP does not prevent bleeding, but carries the risk of transfusion-related morbidity. However, up to 50% of FFP is administered to non-bleeding ICU patients. With the aim to investigate whether prophylactic FFP transfusions to critically ill patients can be safely omitted, a multi-center randomized clinical trial is conducted in ICU patients with a coagulopathy undergoing an invasive procedure.

methodsA non-inferiority, prospective, multicenter randomized open-label, blinded end point evaluation (PROBE) trial. In the intervention group, a prophylactic transfusion of FFP prior to an invasive procedure is omitted compared to transfusion of a fixed dose of 12 ml/kg in the control group. Primary outcome measure is relevant bleeding. Secondary outcome measures are minor bleeding, correction of International Normalized Ratio, onset of acute lung injury, length of ventilation days and length of Intensive Care Unit stay. DISCUSSION: The Transfusion of Fresh Frozen Plasma in non-bleeding ICU patients (TOPIC) trial is the first multi-center randomized controlled trial powered to investigate whether it is safe to withhold FFP transfusion to coagulopathic critically ill patients undergoing an invasive procedure.

trial registrationTrial registration: Dutch Trial Register NTR2262 and ClinicalTrials.gov: NCT01143909.

Indexed as

Blood Component TransfusionClinical ProtocolsPlasmaHumansIntensive Care Units

Identifiers

PMID22196464
PMCPMC3284461
OpenAlexW2149258048

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.