The determination of a panel of markers associated with endothelial cell activation and/or damage in patients with a hematologic malignancy, receiving intensive treatment, or sickle cell disease in relation to the effects of transfusion intervention…
ID
Source
Brief title
Condition
- Haematological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical endpoints:
For the hemato-oncological patients:
- bleeding complications
- transfusion efficacy
For the SCD patients
- occurence/existence of organ damage
Laboratory determination of:
P-selectin, activated leukocytes, micro-particles, integrines and cytokines by
flowcytometry;
Hyaluronic acid, vWF and its propeptide with ELISA technique;
and platelet aggregation assays.
Gene expression.
Secondary outcome
not applicable
Background summary
Supportive care with platelet and red blood cell transfusions is standard
practice in both malign as benign haematological diseases. Despite the large
scale usage of bloodproducts there are still a large number of unresolved
issues with regard to indications and efficacy. There is concrete evidence in
literature that patient-related pathophysiologic processes are the main
determinants of transfusion outcomes and clinical complications. Evidence
suggests an important role of endothelial cell activation and damage, and a
number os studies indeed has shown correlations between different markers of
endothelial damage and clinical complications. This pilot study aims to test a
number of markers of endothelial activation and damage in relation to clinical
outcome and transfusion efficacy. The goal, eventually, is to identify markers
useful to test in clinical transfusion studies.
Study objective
The determination of a panel of markers associated with endothelial cell
activation and/or damage in patients with a hematologic malignancy, receiving
intensive treatment, or sickle cell disease in relation to the effects of
transfusion intervention.
Study design
In 20 patients with a hemato-oncological malignancy, receiving intensive
treatment, blood samples will be drawn before en after platelet transfusion. In
patients with SCD treated with chronic exchange transfusions blood samples will
be drawn before and after the exchange. In SCD patients not treated with
transfusions a single blood sample will be drawn.
Inclusion criteria: informed consent, age > 18 years, hemato-oncological
disease or Sickle cell disease.
Exclusion criteria: active cardiovascular disease, recent thromboembolism.
Some laboratory tests will be performed immediately, however for logistical
reasons a part of the samples will be stored for later determination.
Clinical outcomes will be acquired using the medical charts and administrated
in case report forms.
After completion of the pilot study, the patient characteristsics as well as
clinical outcome will be analysed using chi-square tests. The laboratory values
will be compared using a student-t test.
Study burden and risks
There are no additional risks associated with participation and only a minor
burden (venous blood sampling).
Leyweg 275
2545 CH
Nederland
Leyweg 275
2545 CH
Nederland
Listed location countries
Age
Inclusion criteria
1. Age > or <= 18 years
2. Hemato-oncologic diagnosis, expected to receive > 2 platelet transfusions
3. patients with sickle cell disease
4. informed consent
Exclusion criteria
1. Active cardiovascular disease
2. Recent thrombotic event
3. The usage of Ascal
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16512.098.07 |