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

Haga Hospital
Leyweg 275
Den Haag
2545 CH
Netherlands

Phone +31 (0)70 359 2004
Email J.Kerkhoffs@hagaziekenhuis.nl

Study information

Primary study designInterventional
Study designNon-randomised, parallel group clinical trial
Secondary study designSingle-centre
Scientific title
Study acronymThe marker study
Study objectivesEfficacy 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) studiedSickle cell disease
InterventionPatients 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 typeOther
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 date01/04/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target sample size at registration40
Key inclusion criteria1. Age greater than 18 years
2. Haemato-oncological disease
3. Sickle cell disease
4. Informed consent
Key exclusion criteria1. Active cardiovascular disease
2. Recent thrombo-embolism
Date of first enrolment01/04/2007
Date of final enrolment01/04/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Haga Hospital
Den Haag
2545 CH
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan