To assess the relation between bleeding tendency (patients with WHO grade II or more) and platelet function and platelet /count in patients with hemato-oncological disease
ID
Source
Brief title
Condition
- Anaemias nonhaemolytic and marrow depression
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective: To assess the relation between bleeding tendency (patients
with WHO grade II or more) and platelet function and platelet /count.
Secondary outcome
1. To assess the relation between bleeding tendency (all grades) and platelet
function and platelet count.
2. To assess the percentage of days with WHO grade II or more bleeding and
platelet function. 3. To assess the relation between vascular damage
(endothelial cell markers in plasma) and bleeding tendency (all grades).
4. To assess the bleeding observation score, vascular damage and platelet
function in patients upon remission-induction chemotherapy for acute leukemia/
myelodysplastic syndrome and other diseases.
5. To assess the influence of infection (SIRS criteria) on the bleeding
observation score, vascular damage and platelet function.
6. To assess the influence of platelet transfusions on the health related
quality of life in thrombocytopenic hemato-oncological patients.
Background summary
Platelet transfusions are generally accepted to prevent and treat bleeding
complications in patients with thrombocytopenia due to myelosuppressive
treatment or malignancy. Bleeding is patients with trombocytopenia depends to
some extent on the amount of blood platelets present. The amount of platelets
in normal individuals is (too) high. The normal count is between 150-350.000.
Nevertheless, signs of bleeding are expected when the count is below 30-50.000.
Even in the range of a low platelet count, bleeding is very difficult to
predict. The platelet count itself is not a good predictor and platelet
function is likely to be much more important. Indeed, in a pilot we observed
bleeding in patients with immune mediated destruction of platelets to be
depended on function, merely than count. In patients with chemotherapy induced
thrombocytopenia, bleeding was also dependent on function and not on count.
Platelet transfusions are associated with adverse events and are given at high
costs. Mild to moderate reactions to platelet transfusions include rigors,
fever, and urticaria. These reactions are not life-threatening but can be
extremely distressing for the patient. Rarer, but more serious sequelae
include: anaphylaxis; transfusion-transmitted infections; transfusion-related
acute lung injury; and immunomodulatory effects. Costs involved are
considerable (500 euro per unit, total costs in The Netherlands 70 million
euro) To improve future transfusion strategies, we will study the relation
between bleeding complications and platelet function in patients with
thrombocytopenia due to myelosuppressive treatment. A pilot (feasibility) study
is already been performed in Meander MC. Platelet function will be measured by
a new flowcytometry based assay. This assay is validated for platelet function
testing at low platelet count. A pilot (feasibility) study is already been
performed in Meander MC. Any strategy that can safely decrease the need for
prophylactic platelet transfusions in haematology patients will have
significant logistical and financial implications as well as decreasing
patients* exposure to the risks of transfusion. A safe strategy in the future
with platelet function as a parameter for transfusion instead of platelet count
will improve transfusion strategies, with important economic (less
transfusions/costs) and clinical (less donor exposition/side effects of
transfusion) consequences. In addittion, there is no literature available which
evaluates the effect of platelet transfusions on the health related quality of
life in this population. To our opinion, this should also be considered before
initiating platelet transfusions.
Study objective
To assess the relation between bleeding tendency (patients with WHO grade II or
more) and platelet function and platelet /count in patients with
hemato-oncological disease
Study design
The relation between bleeding observation score and platelet function will be
studied in a multicentre prospective cohort study in 150 patients with
hemato-oncological disease. Patients can be included for a maximum of 6 times
during each treatment cycle. Duration: 4 years
Study burden and risks
Minimal risk on bleeding upon venapunction
Maatweg 3
Amersfoort 3813 TZ
NL
Maatweg 3
Amersfoort 3813 TZ
NL
Listed location countries
Age
Inclusion criteria
Age * 18 years.
Expected platelet transfusion support (platelet count <50x10^9/L)
Signed informed consent.
Having a hemato-oncological disease receiving high dose chemotherapy or a stem cell transplantation
Exclusion criteria
Micro-angiopathic thrombocytopenia (TTP, HUS) and ITP
The use of anti-coagulant drugs or drugs affecting platelet function
Design
Recruitment
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 | NL54842.100.15 |