Clinical effectiveness and safety of pooled, random donor platelet concentrates, leukoreduced and stored up to seven days either in additive solution with and without pathogen reduction or plasma in haemato-oncological patients
| ISRCTN | ISRCTN88278819 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88278819 |
| Secondary identifying numbers | HO82; NTR861 |
- Submission date
- 08/02/2007
- Registration date
- 08/02/2007
- Last edited
- 02/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J L H Kerkhoffs
Scientific
Scientific
HagaHospital
Leyweg 275
Den Haag
2545 CH
Netherlands
| Phone | +31 (0)70 359 2004 |
|---|---|
| J.Kerkhoffs@hagaziekenhuis.nl |
Study information
| Study design | Randomised, active-controlled, parallel group multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HOVON 82 |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2007 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 300 |
| Key inclusion criteria | 1. Age minimal 18 years 2. Expected minimal two platelet transfusion requirements 3. Written informed consent 4. Having a haemato-oncological disease |
| Key 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 |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
HagaHospital
Den Haag
2545 CH
Netherlands
2545 CH
Netherlands
Sponsor information
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands)
Research organisation
Research organisation
HOVON Data Center
Erasmus Medical Centre
Daniel den Hoed Clinic
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
| Phone | +31 (0)10 439 1568 |
|---|---|
| hdc@erasmusmc.nl | |
| Website | http://www.hovon.nl/ |
"ROR" |
https://ror.org/056kpdx27 |
Funders
Funder type
Research organisation
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands)
No information available
The Sanquin Blood Supply Foundation (Stichting Sanquin Bloedvoorziening) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
