NCT00000589

Brief Summary

To determine the best, clinically useful procedure to prevent or minimize platelet alloimmunization as a cause of refractoriness to platelet transfusion in patients undergoing marrow ablative chemotherapy for acute myelogenous leukemia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 1989

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1989

Completed
7.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 7, 2016

Status Verified

May 1, 2000

First QC Date

October 27, 1999

Last Update Submit

November 4, 2016

Conditions

Blood PlateletsHematologic DiseasesImmunizationLeukemia, Myelocytic, AcuteBlood Transfusion

Interventions

platelet transfusionPROCEDURE

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Male and female thrombocytopenic patients, ages 15 and over, newly diagnosed with acute myelogenous leukemia (AML) and undergoing chemotherapy.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • Kao KJ, Mickel M, Braine HG, Davis K, Enright H, Gernsheimer T, Gillespie MJ, Kickler TS, Lee EJ, McCullough JJ, et al. White cell reduction in platelet concentrates and packed red cells by filtration: a multicenter clinical trial. The Trap Study Group. Transfusion. 1995 Jan;35(1):13-9. doi: 10.1046/j.1537-2995.1995.35195090653.x.

    PMID: 7998062BACKGROUND

  • Trial to Reduce Alloimmunization to Platelets Study Group. Leukocyte reduction and ultraviolet B irradiation of platelets to prevent alloimmunization and refractoriness to platelet transfusions. N Engl J Med. 1997 Dec 25;337(26):1861-9. doi: 10.1056/NEJM199712253372601.

    PMID: 9417523BACKGROUND

  • Davis KB, Slichter SJ, Corash L. Corrected count increment and percent platelet recovery as measures of posttransfusion platelet response: problems and a solution. Transfusion. 1999 Jun;39(6):586-92. doi: 10.1046/j.1537-2995.1999.39060586.x.

    PMID: 10378838BACKGROUND

MeSH Terms

Conditions

Hematologic DiseasesLeukemia, Myeloid, Acute

Interventions

Platelet Transfusion

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBlood TransfusionBiological TherapyTherapeutics

Study Officials

  • Hayden Braine

    Johns Hopkins University

  • Kuo-Jang Kao

    University of Florida

  • Jeffrey McCullough

    University of Minnesota

  • Janice McFarland

    Blood Center of Southeastern Wisconsin

  • Charles Schiffer

    University of Maryland

  • Sherrill Schlichter

    Bloodworks

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

August 1, 1989

Study Completion

July 1, 1997

Last Updated

November 7, 2016

Record last verified: 2000-05