Efficacy of transfusions with platelets stored in platelet additive solution II versus plasma
| ISRCTN | ISRCTN52543592 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52543592 |
| Secondary identifying numbers | P03.113 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 04/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J.L.H Kerkhoffs
Scientific
Scientific
Leyenburg Hospital
Department of Hematology
P.O. Box 40551
Den Haag
2504 LN
Netherlands
| JeanLouis.Kerkhoffs@bloodrtd.nl |
Study information
| Study design | Multicentre, randomised, double blinded, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A multicenter randomised study of the efficacy of transfusions with platelets stored in platelet additive solution II versus plasma |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | Platelet transfusion |
| Intervention | Platelet transfusion, trigger based. |
| Intervention type | Other |
| Primary outcome measure | 1- and 24-hour corrected count increment. |
| Secondary outcome measures | 1. Bleeding complications 2. Transfusion reactions 3. Transfusion interval |
| Overall study start date | 01/10/2003 |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 195 |
| Key inclusion criteria | Patients greater than 18 years expected to receive platelet transfusions. |
| Key exclusion criteria | HLA- and/or HPA allo-immunisation |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 30/04/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leyenburg Hospital,
Den Haag
2504 LN
Netherlands
2504 LN
Netherlands
Sponsor information
Leyenburg Hospital (The Netherlands) - Department of Hematology
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 40551
Den Haag
2504 LN
Netherlands
"ROR" |
https://ror.org/03q4p1y48 |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/11/2006 | Yes | No |
