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Clinical Trials/NCT01976442
NCT01976442
Completed
Not Applicable

Impact of Washed Transfusions in Adult Patients With Acute Myeloid or Lymphoid Leukemia

University of Rochester1 site in 1 country100 target enrollmentMarch 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia, Myeloid, Acute
Sponsor
University of Rochester
Enrollment
100
Locations
1
Primary Endpoint
Survial Rate at 30 Days
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
November 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Neil Blumberg

Professor

University of Rochester

Eligibility Criteria

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

  • all other patients

Outcomes

Primary Outcomes

Survial Rate at 30 Days

Time Frame: 30 days

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

Survial Rate at 60 Days

Time Frame: 60 days

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

Survial Rate at 5 Years

Time Frame: 5 years

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

Survial Rate at 100 Days

Time Frame: 100 days

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

Study Sites (1)

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