Condition category
Haematological Disorders
Date applied
07/03/2007
Date assigned
07/03/2007
Last edited
02/09/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J L H Kerkhoffs

ORCID ID

Contact details

Haga Hospital
Leyweg 275
Den Haag
2545 CH
Netherlands
+31 (0)70 359 2004
J.Kerkhoffs@hagaziekenhuis.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR909

Study information

Scientific title

Acronym

The marker study

Study hypothesis

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

Not provided at time of registration

Study design

Non-randomised, parallel group clinical trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/04/2007

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age greater than 18 years
2. Haemato-oncological disease
3. Sickle cell disease
4. Informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

1. Active cardiovascular disease
2. Recent thrombo-embolism

Recruitment start date

01/04/2007

Recruitment end date

01/04/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Haga Hospital
Den Haag
2545 CH
Netherlands

Sponsor information

Organisation

Sanquin Blood Bank South West Region (The Netherlands)

Sponsor details

Wytemaweg 10
Rotterdam
3015 CN
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Sanquin Blood Bank South West Region (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes