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

NCT ID: NCT01976442

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-11-30

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.

Conditions

Leukemia, Myeloid, Acute; Leukemia, Lymphoblastic, Acute

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

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

• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Neil Blumberg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neil Blumberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester Medical Center, School of Medicine and Dentistry

Locations

Strong Memorial Hospital (University of Rochester Medical Center)

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15588315 (View on PubMed)

Other Identifiers

URMC RSRB00035034

Identifier Type: -

Identifier Source: org_study_id