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CompletedNCT01976442Updated Apr 11, 2017Results posted

Use of Saline-Washed Platelet and Red Cell Transfusions in Adult Acute Leukemia

An observational study in Leukemia, Myeloid, Acute and Leukemia, Lymphoblastic, Acute, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged Up to 50 Years. Per ClinicalTrials.gov, last updated 2017-04-11.

Sponsored by University of Rochester · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
Up to 50 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature.

Read the detailed description

The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature. Key outcomes will be treatment related mortality (deaths at 30, 60 and 100 days) and three year survival.

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Conditions studied

  • Leukemia, Myeloid, Acute
  • Leukemia, Lymphoblastic, Acute

Keywords

  • Leukemia
  • Transfusion
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In context

Leukemia, Myeloid, Acute

3,035 studies on the registry are indexed under Leukemia, Myeloid, Acute; 746 are open to participants now.

This study's enrollment of 100 is below the median of 120 across 323 observational studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

University of Rochester is the lead sponsor of 728 studies on the registry; 115 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population is comprised of 98 men and women who were both diagnosed and treated for Acute Myeloid Leukemia or Acute Lymphoid Leukemia at Strong Memorial Hospital, a tertiary medical center located in Rochester, NY, USA. All of these patients received washed red cell and platelet transfusions as part of the hospital's standard protocol for patients with acute leukemia.

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Inclusion criteria

  • previously untreated patients with a diagnosis of acute leukemia between the ages of 0 and 50 (AML) and 18 and 50 (ALL)

Exclusion criteria

Exclusion Criteria:

  • all other patients
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Survial Rate at 30 Days

    The percentage of patients who were alive at 30 days after transfusion.

    Time frame: 30 days

  2. Survial Rate at 60 Days

    The percentage of patients who were alive at 60 days after transfusion.

    Time frame: 60 days

  3. Survial Rate at 100 Days

    The percentage of patients who were alive at 100 days after transfusion.

    Time frame: 100 days

  4. Survial Rate at 5 Years

    The percentage of patients who were alive at 5 years after transfusion.

    Time frame: 5 years

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Results

Posted Apr 11, 2017
Limitations and caveats
This is a cohort study and thus has limits as to confounding and bias. However, it reproduces the results of a previous single center randomized trial.

Participant flow

Participant flow — Overall Study
MilestoneWashedUnwashed
Started6931
Completed6931
Not completed00

Outcome measures

PrimarySurvial Rate at 30 Days

The percentage of patients who were alive at 30 days after transfusion.

Time frame:
30 days
Reported as:
Number · percentage of participants
Survial Rate at 30 Days
percentage of participantsWashedUnwashed
Survial Rate at 30 Days10097
PrimarySurvial Rate at 60 Days

The percentage of patients who were alive at 60 days after transfusion.

Time frame:
60 days
Reported as:
Number · percentage of participants
Survial Rate at 60 Days
percentage of participantsWashedUnwashed
Survial Rate at 60 Days9794
PrimarySurvial Rate at 100 Days

The percentage of patients who were alive at 100 days after transfusion.

Time frame:
100 days
Reported as:
Number · percentage of participants
Survial Rate at 100 Days
percentage of participantsWashedUnwashed
Survial Rate at 100 Days9687
PrimarySurvial Rate at 5 Years

The percentage of patients who were alive at 5 years after transfusion.

Time frame:
5 years
Reported as:
Number · percentage of participants
Survial Rate at 5 Years
percentage of participantsWashedUnwashed
Survial Rate at 5 Years5539

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Washed———
Unwashed———

Baseline characteristics

Age, Continuous
Age, Continuous(years)WashedUnwashedTotal
Mean40 (1 to 50)30 (2 to 49)35 (1 to 50)
Sex: Female, Male
Sex: Female, Male(Participants)WashedUnwashedTotal
Female461864
Male231336
Region of Enrollment
Region of Enrollment(participants)WashedUnwashedTotal
United States6931100
08

Study locations

1 site
  • Strong Memorial Hospital (University of Rochester Medical Center)
    Rochester, New York 14642, United States
09

References and documents

Publications

  • Blumberg N, Heal JM, Rowe JM. A randomized trial of washed red blood cell and platelet transfusions in adult acute leukemia [ISRCTN76536440]. BMC Blood Disord. 2004 Dec 10;4(1):6. doi: 10.1186/1471-2326-4-6. PubMed 15588315 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01976442
Responsible party
Neil Blumberg (Professor, University of Rochester) — Principal investigator
First posted
Nov 5, 2013
Start date
Mar 2011
Primary completion
Nov 2016
Completion
Nov 2016
Results posted
Apr 11, 2017
Last update
Apr 11, 2017

Study contacts

Neil Blumberg, M.D.
principal investigator · University of Rochester Medical Center, School of Medicine and Dentistry

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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