Evidence map›Paper›PMID 26592377›Full record

Trial reportTrials2015

Transfusion strategy in hematological intensive care unit: study protocol for a randomized controlled trial.

Sylvain P Chantepie, Jean-Baptiste Mear, Lydia Guittet, Benoît Dervaux, Jean-Pierre Marolleau, Fabrice Jardin, Jean-Jacques Dutheil, Jean-Jacques Parienti, Jean-Pierre Vilque, Oumedaly Reman

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02461264 (Randomized Multicenter Trial of Two Transfusion Strategies for Patient Receiving Chemotherapy for Acute Leukemia or Hematopoietic Stem Cells With Medico-economic Evaluation of Cost Minimization.), which is not on this map. Cited by 4 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 3 pooled it
0.8field-weighted citation impact, top 32% 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.

NCT02461264 phase3unknown statusnot on this mapstarted 2016, after this paper: background citation

Randomized Multicenter Trial of Two Transfusion Strategies for Patient Receiving Chemotherapy for Acute Leukemia or Hematopoietic Stem Cells With Medico-economic Evaluation of Cost Minimization.

TypeinterventionalSponsorUniversity Hospital, CaenRan2016 to 2019Enrolled230ConditionsTransfusion Related ComplicationArmsSingle red blood packed cells Transfusion, Two packed red blood cells Transfusion
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
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

10 authors at 2 institutions in 1 country.

Sylvain P ChantepieInstitut d'Hématologie de Basse-Normandie, Centre Hospitalier Universitaire, Côte de Nacre, 14033, Caen, Cedex, France. chantepie-s@chu-caen.fr.
Jean-Baptiste MearInstitut d'Hématologie de Basse-Normandie, Centre Hospitalier Universitaire, Côte de Nacre, 14033, Caen, Cedex, France. mear-jb@chu-caen.fr.
Lydia GuittetU1086 INSERM, Cancers & Préventions, Avenue du General Harris, 14076, Caen, France. guittet-l@chu-caen.fr.
Benoît DervauxSchool of Medicine and University Hospital, Lille, France. benoit.dervaux@chru-lille.fr.
Jean-Pierre MarolleauHématologie clinique et thérapie cellulaire, CHU, Amiens, France. Marolleau.Jean-Pierre@chu-amiens.fr.
Fabrice JardinService d'hématologie, Centre Becquerel, Rouen, France. fabrice.jardin@chb.unicancer.fr.
Jean-Jacques DutheilDépartement de Biostatistiques et de Recherche Clinique, Centre Hospitalier Universitaire, Côte de Nacre, 14033, Caen, Cedex, France. dutheil-jj@chu-caen.fr.
Jean-Jacques ParientiDépartement de Biostatistiques et de Recherche Clinique, Centre Hospitalier Universitaire, Côte de Nacre, 14033, Caen, Cedex, France. parienti-jj@chu-caen.fr.
Jean-Pierre VilqueInstitut d'Hématologie de Basse-Normandie, Centre Hospitalier Universitaire, Côte de Nacre, 14033, Caen, Cedex, France. vilque-jp@chu-caen.fr.
Oumedaly RemanInstitut d'Hématologie de Basse-Normandie, Centre Hospitalier Universitaire, Côte de Nacre, 14033, Caen, Cedex, France. reman-o@chu-caen.fr.
Centre Hospitalier Universitaire de Caen · FRInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPacked red blood cell (PRBC) transfusion is required in hematology patients treated with chemotherapy for acute leukemia, autologous (auto) or allogeneic (allo) hematopoietic stem cell transplantation (HSCT). In certain situations like septic shock, hip surgery, coronary disease or gastrointestinal hemorrhage, a restrictive transfusion strategy is associated with a reduction of infection and death. A transfusion strategy using a single PRBC unit has been retrospectively investigated and showed a safe reduction of PRBC consumption and costs. We therefore designed a study to prospectively demonstrate that the transfusion of a single PRBC unit is safe and not inferior to standard care.

methodsThe 1versus2 trial is a randomized trial which will determine if a single-unit transfusion policy is not inferior to a double-unit transfusion policy. The primary endpoint is the incidence of severe complication (grade ≥ 3) defined as stroke, transient ischemic attack, acute coronary syndrome, heart failure, elevated troponin level, intensive care unit transfer, death, new pulmonary infiltrates, and transfusion-related infections during hospital stays. The secondary endpoint is the number of PRBC units transfused per patient per hospital stay. Two hundred and thirty patients will be randomized to receive a single unit or double unit every time the hemoglobin level is less than 8 g/dL. All patients admitted for induction remission chemotherapy, auto-HSCT or allo-HSCT in hematology intensive care units will be eligible for inclusion. Sample size calculation has determined that a patient population of 230 will be required to prove that the 1-unit PRBC strategy is non-inferior to the 2-unit PRBC strategy. Hemoglobin threshold for transfusion is below 8 g/dL. Estimated percentage of complication-free hospital stays is 93 %. In a non-inferiority hypothesis, the number of patients to include is 230 with a power of 90 % and an alpha risk of 5 %.

trial registration14-128; Clinicaltrials.gov NCT02461264 (registered on 3 June 2015).

Indexed as

HematologyHematopoietic Stem Cell TransplantationIntensive Care UnitsAllograftsAntineoplastic Combined Chemotherapy ProtocolsAutograftsBiomarkersClinical ProtocolsCost-Benefit AnalysisErythrocyte TransfusionFranceHealth Care CostsHemoglobinsHumansInduction ChemotherapyLeukemiaBiomarkersHemoglobins

Identifiers

PMID26592377
PMCPMC4655487
OpenAlexW2174250639

What OpenQuestion holds

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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.