Acute Myeloid Leukemia, Thrombocytopenia
Conditions
Brief summary
Application of a therapeutic platelet transfusion Regimen in patients with acute myeloid leukemia in complete Remission (consolidation therapy)
Detailed description
For the participants a therapeutic regimen for platelet transfusions will be applied: for clinically stable patients platelet Transfusion will be given in case of bleeding WHO II° or higher, for clinically instable patients platelet transfusion will be given at the decretion of the attending physician. Patients with sepsis, septic shock or infections with Infiltration of organs (e.g. invasive aspergillosis), plasmatic coagulation disorders or sudden or increasing headache with or without neurologic symptoms should receive prophylactic platelet Transfusion, if their platelet Count is less then 10/nl. Otherwise no prophylactic platelet Transfusion will be given irrespective of the actual platelet Count. As Primary study endpoint The incidence of bleeding episodes WHO grade III an IV will be documented. The bleeding incidence will then be compared to a historic cohort.
Interventions
None listed
Sponsors
Technische Universität Dresden
University Hospital Heidelberg
Klinikum Chemnitz gGmbH
University Medicine Greifswald
Klinikum Nürnberg
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Acute myeloid leukemia in complete remission
Exclusion criteria
* plasmatic coagulopathy * history of severe bleeding complications in chemotherapy induced thrombocytopenia * no increment in platelets after platelet transfusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding Grade III and IV (WHO) | Patients will be followed for the phase of thrombocytopenia after chemotherapy, an expected average of about 14 days. |
Countries
Germany
Outcome results
None listed