Efficacy of transfusions with platelets stored in platelet additive solution II versus plasma

ISRCTN	ISRCTN52543592
DOI	https://doi.org/10.1186/ISRCTN52543592
Protocol serial number	P03.113
Sponsor	Leyenburg Hospital (The Netherlands) - Department of Hematology
Funder	Not provided at time of registration

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr J.L.H Kerkhoffs
Scientific

Leyenburg Hospital
Department of Hematology
P.O. Box 40551
Den Haag
2504 LN
Netherlands

Email	JeanLouis.Kerkhoffs@bloodrtd.nl

Primary study design	Interventional
Study design	Multicentre, randomised, double blinded, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	A multicenter randomised study of the efficacy of transfusions with platelets stored in platelet additive solution II versus plasma
Study objectives	Utilisation of platelets stored in additive solutions has several advantages. A former Randomised Controlled Trial (RCT) testing platelets stored in platelet additive solution II versus plasma excluded patients with factors of increased platelet consumption. In this study also this category of patients are included and we expect to find differences in outcome, as compared to the previous study.
Ethics approval(s)	The study protocol was approved by the Leiden University Medical Center and HagaZiekenhuis ethics committees and conducted according to the Guidelines of Good Clinical Practice.
Health condition(s) or problem(s) studied	Platelet transfusion
Intervention	Platelet transfusion, trigger based.
Intervention type	Other
Primary outcome measure(s)	1- and 24-hour corrected count increment.
Key secondary outcome measure(s)	1. Bleeding complications 2. Transfusion reactions 3. Transfusion interval
Completion date	30/04/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	195
Key inclusion criteria	Patients greater than 18 years expected to receive platelet transfusions.
Key exclusion criteria	HLA- and/or HPA allo-immunisation
Date of first enrolment	01/10/2003
Date of final enrolment	30/04/2005

Leyenburg Hospital,

Den Haag
2504 LN
Netherlands

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	01/11/2006		Yes	No