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

Leukemia, Myeloid, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976442
• Other study ID #: URMC RSRB00035034
• Status: Completed
• Phase: N/A
• First received: October 16, 2013
• Last updated: April 10, 2017
• Start date: March 2011
• Est. completion date: November 2016

Study information

• Verified date: April 2017
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoblastic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
United States	Strong Memorial Hospital (University of Rochester Medical Center)	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survial Rate at 30 Days	The percentage of patients who were alive at 30 days after transfusion.	30 days
Primary	Survial Rate at 60 Days	The percentage of patients who were alive at 60 days after transfusion.	60 days
Primary	Survial Rate at 100 Days	The percentage of patients who were alive at 100 days after transfusion.	100 days
Primary	Survial Rate at 5 Years	The percentage of patients who were alive at 5 years after transfusion.	5 years