Condition category
Signs and Symptoms
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
04/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Leyenburg Hospital (The Netherlands) - Department of Hematology

Sponsor details

P.O. Box 40551
Den Haag
2504 LN
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes