Washed blood components in adult acute leukemia

ISRCTN	ISRCTN76536440
DOI	https://doi.org/10.1186/ISRCTN76536440
Protocol serial number	N/A
Sponsor	University of Rochester (USA)
Funders	University of Rochester (USA), CaridianBCT Inc. (formerly Gambro BCT Inc.) (USA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Neil Blumberg
Scientific

601 Elmwood Avenue
Box 608
Rochester
14642
United States of America

Phone	+1 585 275 9656
Email	neil_blumberg@urmc.rochester.edu

Primary study design	Interventional
Study design	Randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Acute Leukemia
Intervention	The control intervention was leukocyte reduced red cell and platelet transfusions, the standard practice in most hospitals. The experimental intervention was leukocyte reduced red cell and platelet transfusions that had also been plasma reduced by washing.
Intervention type	Other
Primary outcome measure(s)	Added 14/08/09: 1. Platelet transfusion refractoriness 2. Infectious and bleeding complications 3. Overall survival.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/1994

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	43
Key inclusion criteria	Adult patients with acute leukemia undergoing full dose remission induction chemotherapy.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/01/1991
Date of final enrolment	31/12/1994

601 Elmwood Avenue

Rochester
14642
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/12/2004		Yes	No