Condition category
Haematological Disorders
Date applied
08/02/2007
Date assigned
08/02/2007
Last edited
02/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hovon.nl

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

http://www.hovon.nl/

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

Publication citations

Additional files

Editorial Notes