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Completed

NCT Number: NCT01976442

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

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.

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Key information

Age range

Up to 50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Strong Memorial Hospital (University of Rochester Medical Center)

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Survial Rate at 30 Days

    Time frame: 30 days

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

  2. Survial Rate at 60 Days

    Time frame: 60 days

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

  3. Survial Rate at 100 Days

    Time frame: 100 days

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

  4. Survial Rate at 5 Years

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2013
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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