NCT00000581

Brief Summary

To evaluate granulocyte transfusion therapy with respect to its prophylactic and therapeutic effectiveness to prevent and aid recovery from infection. The study trials were conducted simultaneously.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1976

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

September 1, 1976

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1981

Completed
18.2 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 26, 2013

Status Verified

January 1, 2000

First QC Date

October 27, 1999

Last Update Submit

November 25, 2013

Conditions

Blood TransfusionInfection

Interventions

leukocyte transfusionsPROCEDURE

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Prophylactic Trial: males and females, 12 years or older, who were in the first induction phase of chemotherapy for acute leukemia, who had severe neutropenia, and who did not have documented infection. Therapeutic Trial: males and females, any

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

Sponsors & Collaborators

Related Publications (2)

  • Strauss RG, Connett JE, Gale RP, Bloomfield CD, Herzig GP, McCullough J, Maguire LC, Winston DJ, Ho W, Stump DC, Miller WV, Koepke JA. A controlled trial of prophylactic granulocyte transfusions during initial induction chemotherapy for acute myelogenous leukemia. N Engl J Med. 1981 Sep 10;305(11):597-603. doi: 10.1056/NEJM198109103051101.

    PMID: 6790985BACKGROUND

  • Winston DJ, Ho WG, Gale RP. Prophylactic granulocyte transfusions during chemotherapy of acute nonlymphocytic leukemia. Ann Intern Med. 1981 May;94(5):616-22. doi: 10.7326/0003-4819-94-5-616.

    PMID: 6263139BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

Leukocyte Transfusion

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBlood TransfusionBiological TherapyTherapeutics

Study Officials

  • Robert Gale

    University of California

  • Geoffrey Herzig

    Washington University School of Medicine

  • Ronald Strauss

    University of Iowa

Study Design

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

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1976

Study Completion

September 1, 1981

Last Updated

November 26, 2013

Record last verified: 2000-01