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

NCT01976442 | Completed Results

• 1 other identifier: URMC RSRB00035034
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Myeloid, Acute; Leukemia, Lymphoblastic, Acute

Keywords

Leukemia; Transfusion

Outcome Measures

Primary Outcomes (4)

• Survial Rate at 30 Days

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

  30 days

• Survial Rate at 60 Days

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

  60 days

• Survial Rate at 100 Days

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

  100 days

• Survial Rate at 5 Years

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

  5 years

Eligibility Criteria

• Age: Up to 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• all other patients

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Strong Memorial Hospital (University of Rochester Medical Center)

Rochester, New York, 14642, United States

Location

Related 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. doi: 10.1186/1471-2326-4-6.

  PMID: 15588315 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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.

Results Point of Contact

• Title: Neil Blumberg MD
• Organization: University of Rochester Medical Center

neil_blumberg@urmc.rochester.edu

(585) 275-3189

Study Officials

• Neil Blumberg, M.D.

  University of Rochester Medical Center, School of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: November 5, 2013
• Study Start: March 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-04

Locations

US (1)