Evidence map›Paper›PMID 27198129›Full record

Trial reportTransfusion2016

Red blood cell transfusion triggers in acute leukemia: a randomized pilot study.

Amy E DeZern, Katherine Williams, Marianna Zahurak, Wesley Hand, R Scott Stephens, Karen E King, Steven M Frank, Paul M Ness

Erratum issued Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Transfusion, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02086773 (Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias), which is not on this map. Cited by 38 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 7 pooled it
5.6field-weighted citation impact, top 4% 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.

NCT02086773 phase1completednot on this map

Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2014 to 2015Enrolled90ConditionsAcute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Acute Promyelocytic Leukemia (APL)ArmsRed blood cell transfusion
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 7 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Guideline
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  4. Transfusion thresholds for guiding red blood cell transfusion.The Cochrane database of systematic reviews · 2021
    Pooled it
  5. Guideline
  6. Pooled it
  7. Pooled it
  8. Trial
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  10. Trial
  11. Article
  12. Review
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  14. Observational
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Amy E DeZernThe Sidney Kimmel Cancer Center at Johns Hopkins, The Johns Hopkins School of Medicine, Baltimore, Maryland.
Katherine WilliamsThe Sidney Kimmel Cancer Center at Johns Hopkins, The Johns Hopkins School of Medicine, Baltimore, Maryland.
Marianna ZahurakThe Sidney Kimmel Cancer Center at Johns Hopkins, The Johns Hopkins School of Medicine, Baltimore, Maryland.
Wesley HandThe Sidney Kimmel Cancer Center at Johns Hopkins, The Johns Hopkins School of Medicine, Baltimore, Maryland.
R Scott StephensThe Sidney Kimmel Cancer Center at Johns Hopkins, The Johns Hopkins School of Medicine, Baltimore, Maryland.
Karen E KingThe Sidney Kimmel Cancer Center at Johns Hopkins, The Johns Hopkins School of Medicine, Baltimore, Maryland.
Steven M FrankDepartment of Anesthesiology and Critical Care Medicine, The Johns Hopkins School of Medicine, Baltimore, Maryland.
Paul M NessDivision of Transfusion Medicine, Department of Pathology, The Johns Hopkins School of Medicine, Baltimore, Maryland.
Johns Hopkins University · USJohns Hopkins Medicine · USSidney Kimmel Cancer Center · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
TUMOR VACCINESP01CA015396 · NCI · JOHNS HOPKINS UNIVERSITY · PI HESS, ALLAN D · 1985 to 2016
$38.1M
NCI NIH HHS P01 CA015396NCI NIH HHS P30 CA006973
6 · The paper itself

Abstract

backgroundRed blood cell (RBC) transfusion thresholds have yet to be examined in large randomized trials in hematologic malignancies. This pilot study in acute leukemia uses a restrictive compared to a liberal transfusion strategy. STUDY DESIGN AND

methodsA randomized (2:1) study was conducted of restrictive (LOW) hemoglobin (Hb) trigger (7 g/dL) compared to higher (HIGH) Hb trigger (8 g/dL). The primary outcome was feasibility of conducting a larger trial. The four requirements for success required that more than 50% of the eligible patients could be consented, more than 75% of the patients randomized to the LOW arm tolerated the transfusion trigger, fewer than 15% of patients crossed over from the LOW arm to the HIGH arm, and no indication for the need to pause the study for safety concerns. Secondary outcomes included fatigue, bleeding, and RBCs and platelets transfused.

resultsNinety patients were consented and randomly assigned to LOW to HIGH. The four criteria for the primary objective of feasibility were met. When the number of units transfused was compared, adjusting for baseline Hb, the LOW arm was transfused on average 8.0 (95% confidence interval [CI], 6.9-9.1) units/patient while the HIGH arm received 11.7 (95% CI, 10.1-13.2) units (p = 0.0003). There was no significant difference in bleeding events or neutropenic fevers between study arms.

conclusionThis study establishes feasibility for trial of Hb thresholds in leukemia through demonstration of success in all primary outcome metrics and a favorable safety profile. This population requires further study to evaluate the equivalence of liberal and restrictive transfusion thresholds in this unique clinical setting.

Indexed as

Erythrocyte TransfusionAcute DiseaseAgedFemaleHemoglobinsHumansLeukemiaMaleMiddle AgedPilot ProjectsPractice Guidelines as TopicHemoglobins

Identifiers

PMID27198129
PMCPMC4986514
OpenAlexW2434024560

What OpenQuestion holds

Textmetadata
LicenceTDM
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.