Markers of endothelial activation and damage in haematological patients in relation to efficacy of transfusion support: a pilot study
| ISRCTN | ISRCTN35472475 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35472475 |
| Protocol serial number | NTR909 |
| Sponsor | Sanquin Blood Bank South West Region (The Netherlands) |
| Funder | Sanquin Blood Bank South West Region (The Netherlands) |
- Submission date
- 07/03/2007
- Registration date
- 07/03/2007
- 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
Haga Hospital
Leyweg 275
Den Haag
2545 CH
Netherlands
| Phone | +31 (0)70 359 2004 |
|---|---|
| J.Kerkhoffs@hagaziekenhuis.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised, parallel group clinical trial |
| Secondary study design | Single-centre |
| Scientific title | |
| Study acronym | The marker study |
| Study objectives | Efficacy of transfusion support depends on disease and treatment related patient factors. Markers of endothelial damage have been identified, but until today not in relation to the efficacy of transfusions. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Sickle cell disease |
| Intervention | Patients with a haemato-oncological diagnosis will receive platelet transfusion and patients with sickle cell disease will receive red blood cell exchange. Two blood samples will be drawn, before and after this intervention, and these samples will be used to test several known markers of endothelial cell activation/damage. |
| Intervention type | Other |
| Primary outcome measure(s) |
Efficacy of platelet transfusion or red blood cell exchange transfusion in haemato-oncological patients and sickle cell patients, respectively, in relation to several endothelial activation markers. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Age greater than 18 years 2. Haemato-oncological disease 3. Sickle cell disease 4. Informed consent |
| Key exclusion criteria | 1. Active cardiovascular disease 2. Recent thrombo-embolism |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/04/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Haga Hospital
Den Haag
2545 CH
Netherlands
2545 CH
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |