Observational Trial of a Therapeutic Platelet Transfusion Regimen
Conditions
Acute Myeloid Leukemia - Thrombocytopenia
Conditions: official terms
Leukemia, Myeloid - Leukemia, Myeloid, Acute - Thrombocytopenia
Study Type
Observational
Study Phase
Phase 4
Study Design
Observational Model: Case Control, Time Perspective: Prospective
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Start Date
November 2014
Completion Date
November 2016
Sponsors
Klinikum Nürnberg
Source
Klinikum Nürnberg
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page