Contact information
Type
Scientific
Primary contact
Dr J L H Kerkhoffs
ORCID ID
Contact details
HagaHospital
Leyweg 275
Den Haag
2545 CH
Netherlands
+31 (0)70 359 2004
J.Kerkhoffs@hagaziekenhuis.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HO82; NTR861
Study information
Scientific title
Acronym
HOVON 82
Study hypothesis
Platelet additive solution platelet concentrates (PAS III-PC) and pathogen reduced (PR)-PAS III-PC are non-inferior compared to plasma platelet concentrates (Plasma-PC) in terms of recovery, estimated by the one-hour corrected count increments (CCI) post-transfusion.
Secondary objectives:
1. To assess the effectiveness in relation to storage time of the used platelet product
2. To evaluate whether clinical factors interact with the different study products leading to a difference in platelet refractoriness
3. To assess the 24-hour CCI
4. To assess the safety (bleeding complications and adverse transfusion reactions)
5. To assess transfusion requirement (red cells and platelets)
6. To assess the transfusion interval
Ethics approval
Approval received from the local ethics committee (METC Zuidwest Holland) on the 22nd January 2007 (ref: METC protocol-nr 06-094) (ref. of approval letter: 2007-054).
Study design
Randomised, active-controlled, parallel group multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Thrombocytopenia
Intervention
All patients will be randomised to receive one of three platelet products during one transfusion period:
Arm A: plasma stored platelet concentrates (Plasma-PC)
Arm B: PAS III stored platelet concentrates (PAS III-PC)
Arm C: pathogen reduced PAS III stored platelet concentrates (PR-PAS III-PC)
Duration of study will be one transfusion period, which is defined as a period of six weeks or a maximum of five transfusions.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
One-hour CCI.
Secondary outcome measures
1. 24 hour CCI
2. Bleeding grade minimal two (Common Terminology Criteria for Adverse Events version three [CTCAE v 3.0])
3. Transfusion requirement, red cells and platelets
4. Platelet transfusion interval
5. Adverse transfusion reactions
Overall trial start date
01/02/2007
Overall trial end date
01/02/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age minimal 18 years
2. Expected minimal two platelet transfusion requirements
3. Written informed consent
4. Having a haemato-oncological disease
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
300
Participant exclusion criteria
1. Known immunological refractoriness to platelet transfusions, i.e. human leukocyte antigen (HLA)- and/or human platelet antigen (HPA)-alloimmunisation and/or clinical relevant auto-antibodies
2. Pregnancy (or lactating)
3. Previous inclusion in this study
Recruitment start date
01/02/2007
Recruitment end date
01/02/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
HagaHospital
Den Haag
2545 CH
Netherlands
Sponsor information
Organisation
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands)
Sponsor details
HOVON Data Center
Erasmus Medical Centre
Daniel den Hoed Clinic
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 439 1568
hdc@erasmusmc.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Sanquin Blood Supply Foundation (Stichting Sanquin Bloedvoorziening) (The Netherlands)
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