Contact information
Type
Scientific
Primary contact
Dr J.L.H Kerkhoffs
ORCID ID
Contact details
Leyenburg Hospital
Department of Hematology
P.O. Box 40551
Den Haag
2504 LN
Netherlands
JeanLouis.Kerkhoffs@bloodrtd.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P03.113
Study information
Scientific title
A multicenter randomised study of the efficacy of transfusions with platelets stored in platelet additive solution II versus plasma
Acronym
Study hypothesis
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
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.
Study design
Multicentre, randomised, double blinded, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Platelet transfusion
Intervention
Platelet transfusion, trigger based.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1- and 24-hour corrected count increment.
Secondary outcome measures
1. Bleeding complications
2. Transfusion reactions
3. Transfusion interval
Overall trial start date
01/10/2003
Overall trial end date
30/04/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients greater than 18 years expected to receive platelet transfusions.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
195
Participant exclusion criteria
HLA- and/or HPA allo-immunisation
Recruitment start date
01/10/2003
Recruitment end date
30/04/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leyenburg Hospital,
Den Haag
2504 LN
Netherlands
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=16825492
Publication citations
-
Results
Kerkhoffs JL, Eikenboom JC, Schipperus MS, van Wordragen-Vlaswinkel RJ, Brand R, Harvey MS, de Vries RR, Barge R, van Rhenen DJ, Brand A, A multicenter randomized study of the efficacy of transfusions with platelets stored in platelet additive solution II versus plasma., Blood, 2006, 108, 9, 3210-3215, doi: 10.1182/blood-2006-04-020131.