NCT02086773

Brief Summary

The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL, has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

March 4, 2014

Last Update Submit

January 22, 2019

Conditions

Acute Lymphoblastic LeukemiaAcute Lymphocytic Leukemia (ALL)Acute Myelogenous Leukemia (AML)Acute Promyelocytic Leukemia (APL)

Keywords

Acute LeukemiaRed Cell Transfusion

Outcome Measures

Primary Outcomes (1)

  • Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm.

    60 days

Secondary Outcomes (18)

  • Safety of low vs. high transfusion threshold as assessed by total difference in number of transfusions given per participant

    60 days

  • Safety of low vs. high transfusion threshold as assessed by number of participants experiencing neutropenic infections

    60 days

  • Safety of low vs. high transfusion threshold as assessed by number of grade 3-4 bleeding events as defined by CTCAE 4.0

    60 days

  • Safety of low vs. high transfusion threshold as assessed by number of deaths attributed to induction chemotherapy

    60 days

  • Safety of low vs. high transfusion threshold as assessed by number of participants with at least one grade 3-5 non-hematological toxicity by CTCAE 4.0.

    60 days

  • +13 more secondary outcomes

Study Arms (2)

Low transfusion threshold

EXPERIMENTAL

Patients receive red blood cell transfusions with a transfusion threshold of 7 g/dL hemoglobin (Hb). Transfusions will not be given on schedule but will be given whenever Hb dips below the threshold.

Biological: Red blood cell transfusion

High transfusion threshold

ACTIVE COMPARATOR

Patients receive red blood cell transfusions with a transfusion threshold of 8 g/dL hemoglobin (Hb). Transfusions will not be given on schedule but will be given whenever Hb dips below the threshold.

Biological: Red blood cell transfusion

Interventions

Red blood cell transfusionBIOLOGICAL
Also known as: PRBC transfusion, RBC transfusion
High transfusion thresholdLow transfusion threshold

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute leukemia patients (AML, ALL, APL, treatment-related myeloid neoplasm, high grade MDS)
  • Admitted with plans for inpatient myelosuppressive chemotherapy (with standard of care or protocol regimens)

You may not qualify if:

  • Age less than 18 years
  • Acute coronary syndrome as defined by active chest pain, dynamic ECG changes, troponin greater than 2.5
  • Active blood loss
  • Receiving erythropoietin stimulating agents prior to admission
  • Chronic Renal Failure in Renal Replacement Therapy
  • Documented wish against transfusion for personal or religious beliefs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

  • DeZern AE, Williams K, Zahurak M, Hand W, Stephens RS, King KE, Frank SM, Ness PM. Red blood cell transfusion triggers in acute leukemia: a randomized pilot study. Transfusion. 2016 Jul;56(7):1750-7. doi: 10.1111/trf.13658. Epub 2016 May 20.

    PMID: 27198129RESULT

  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

  • Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

    PMID: 34932836DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Promyelocytic, Acute

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBlood TransfusionBiological TherapyTherapeutics

Study Officials

  • Amy DeZern, MD, MHS

    The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 13, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 24, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)