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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR861 |
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Date of registration:
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11/01/2007 |
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Primary sponsor: |
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Public title:
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Clinical effectiveness and safety of pooled, random donor platelet concentrates, leucoreduced and stored up to seven days either in additive solution with and without pathogen reduction or plasma in hemato-oncological patients.
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Scientific title:
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Clinical effectiveness and safety of pooled, random donor platelet concentrates, leucoreduced and stored up to seven days either in additive solution with and without pathogen reduction or plasma in hemato-oncological patients. - HOVON 82 |
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Date of first enrolment:
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1/2/2007 |
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Target sample size:
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300 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=861 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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J.L.H.
Kerkhoffs |
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Address:
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HagaHospital,
Leyweg 275
2545 CH
Den Haag
The Netherlands |
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Telephone:
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+31 (0)70 3592004 |
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Email:
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J.Kerkhoffs@hagaziekenhuis.nl |
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Affiliation:
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Name:
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J.L.H.
Kerkhoffs |
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Address:
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HagaHospital,
Leyweg 275
2545 CH
Den Haag
The Netherlands |
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Telephone:
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+31 (0)70 3592004 |
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Email:
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J.Kerkhoffs@hagaziekenhuis.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age minimal 18 years;
2. Expected minimal 2 platelet transfusion requirements;
3. Written informed consent;
4. Having a hemato-oncological disease
Exclusion criteria: 1. Known immunological refractoriness to platelet transfusions, i.e. HLA- and/or HPA-allo immunization and/or clinical relevant auto-antibodies;
2. Pregnancy (or lactating);
3. Previous inclusion in this study
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Hemato-oncological patients, Thrombocytopenia
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Intervention(s)
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All patients will be randomized to receive one of three platelet products during one transfusion period:
1. Arm A: Plasma stored platelet concentrates (Plasma-PC);
2. Arm B: PAS III stored platelet concentrates (PAS III-PC);
3. Arm C: Pathogen reduced PAS III stored platelet concentrates (PR-PAS III-PC).
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Primary Outcome(s)
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1. 1 hour CCI
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Secondary Outcome(s)
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1. 24 hour CCI
2. Bleeding grade minimal 2 (CTCAE v3.0)
3. Transfusion requirement, red cells and platelets
4. Platelet transfusion interval
5. Adverse transfusion reactions
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Secondary ID(s)
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HO82
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ISRCTN88278819
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Source(s) of Monetary Support
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Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Sanquin Blood Supply
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