Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Randomized Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups: 1)in Patients With Acute Myeloid Leukemia After Intensive Chemotherapy and 2) After Autologous Blood Stem Cell Transplantation
Brief Summary: The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e. platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without any sign of bleeding when the platelet count is below 10.000/µL). With the experimental transfusion strategy transfusions could be safely reduced when the study hypothesis can be proven. This is the first prospective randomized study on this topic.


Options:
A: Inclusion Criteria:

AML project

* inclusion in studies of the DSIL or OSHO group for AML
* AML M3/M3v can be included only when in complete remission
* age 16 - 80 years
* written informed consent

Autologous project

* AMl and ALL patients in first or second remission
* low grade or high grade non hodgkin lymphoma or morbus hodgkin or multiple myeloma
* conditioning regime: TBI 8-12 Gy/Cy 120 or BEAM or BU/CY or Melphalan 140-200mg/m2 or a similarly intensive chemotherapy regime
* age 16 - 65 years

Exclusion Criteria:

AML project

* known refractoriness to platelet transfusion
* known major bleeding with thrombocytopenia when the reason for bleeding is still ongoing
* known plasmatic coagulation disorder
* patient unable to give informed consent

Autologous project

* known refractoriness to platelet transfusion
* known major bleeding with thrombocytopenia when the reason for bleeding is still ongoing
* known plasmatic coagulation disorder
* patient unable to give informed consent
* patients with pulmonal or cerebral lesions due to infection or neoplasm
* patients with al-amyloidosis
B: Inclusion Criteria:

* Has, or is expected to have, hypoproliferative thrombocytopenia, and is expected to have a platelet count of up to 10,000 ul for at least 5 days and be in the hospital for at least 5 days
* Weight is between 10 and 135 kilograms
* PT/INR, PTT, and fibrinogen assays that are measured within 72 hours before study entry are as follows:

  1. PT less than or equal to 1.3 times the upper limit of normal for the laboratory
  2. PTT less than or equal to 1.3 times the upper limit of normal for the laboratory
  3. Fibrinogen greater than or equal to 100 mg/dl
* Undergoing, or has completed, hematopoietic stem cell transplantation, for any diagnosis; OR has a diagnosis of acute or chronic leukemia, non-Hodgkins or Hodgkins lymphoma, myeloma, myelodysplasia, or non-hematologic malignancy and is undergoing, or has completed, chemotherapy
* During this hospitalization, the patient has not yet received any platelet transfusions related to the current or planned course of therapy (individual platelet transfusions given prior to the study and unrelated to thrombocytopenia will not exclude the patient)

Exclusion Criteria:

* Evidence of greater than or equal to Grade 2 bleeding (as determined by the Platelet Dose Trial Bleeding Scale)
* Receiving antithrombotic drugs
* Will receive bedside leuko-reduced platelet transfusions
* Present, or history of, platelet transfusion refractoriness within 30 days prior to study entry
* Pre-enrollment lymphocytotoxic antibody screen (PRA) known to be greater than or equal to 20% based on prior data
* Present, or history of, acute promyelocytic leukemia (APML), immune thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic-uremic syndrome (HUS)
* Will be transfused at platelet trigger of greater than 10,000 platelets/ul
* Recent history of major surgery (within 2 weeks of study entry)
* Currently taking, or participating in a study involving, platelet substitutes, platelet growth factors, or pharmacologic agents intended to enhance or decrease platelet hemostatic function
* Pregnant
* Previously enrolled in this study
C: Inclusion Criteria:

* All patients acquiring a central venous catheter

Exclusion Criteria:

* Patients pre or post surgery
* Patients with bleeding due to other reason
D: Inclusion Criteria:

* Patients with hypoproliferative thrombocytopenia who are expected to have a platelet count of ≤ 10,000/µL (10x10\^9/L) for ≥ 10 days (Note: the prophylactic platelet trigger may be higher than10,000/µL (10x10\^9/L) in some participating institutions; however, the patient will still be eligible for participation as long as they are expected to be thrombocytopenic for 10 days)
* Must be an inpatient.
* Weight between 40 and 100 kg.

Exclusion Criteria:

* Diagnosis of promyelocytic leukemia.
* A history or current diagnosis of immune thrombocytopenia (ITP), thrombotic thrombocytopenia (TTP), or hemolytic uremia syndrome (HUS).
* Evidence of ≥ WHO Grade 2 bleeding while being assessed for the study entry.
* Patients who will receive bedside Leukoreduced platelet transfusions.
* Patients who are pregnant.

Answer: A