Observational Trial of a Therapeutic Platelet Transfusion Regimen

Klinikum Nürnberg

Status: Terminated

Conditions: Thrombocytopenia; Acute Myeloid Leukemia

Study type: Observational

Funder types: Other

Identifiers

NCT02276651

001

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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