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

Completed

• Conditions: Leukemia, Myeloid, Acute; Leukemia, Lymphoblastic, Acute

• Registration Number: NCT01976442
• Lead Sponsor: University of Rochester

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-11-05
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2017-02-27
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-10
• Last Update Submitted: 2017-04-10
• Results First Posted: 2017-04-11
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• all other patients

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survial Rate at 30 Days	30 days	The percentage of patients who were alive at 30 days after transfusion.
Survial Rate at 60 Days	60 days	The percentage of patients who were alive at 60 days after transfusion.
Survial Rate at 5 Years	5 years	The percentage of patients who were alive at 5 years after transfusion.
Survial Rate at 100 Days	100 days	The percentage of patients who were alive at 100 days after transfusion.

Trial Locations

Locations (1)

Strong Memorial Hospital (University of Rochester Medical Center); 🇺🇸 Rochester, New York, United States