Observational Trial of a Therapeutic Platelet Transfusion Regimen

Klinikum Nürnberg25 enrolled

Overview

Application of a therapeutic platelet transfusion Regimen in patients with acute myeloid leukemia in complete Remission (consolidation therapy)

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Myeloid Leukemia Thrombocytopenia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinikum Nurnberg

Nuremberg, Germany

Outcomes

Primary Outcomes

Bleeding Grade III and IV (WHO)

Time frame: Patients will be followed for the phase of thrombocytopenia after chemotherapy, an expected average of about 14 days.

Data from ClinicalTrials.gov

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