Thrombocytopenie D69.6
Conditions
Interventions
Group 1: Platelet transfusion
Blood sampling before, 1 and 24 hours after platelet transfusion
Follow-up duration is 7 days after transfusion
Sponsors
Institut für klinische und experimentelle Transfusionsmedizin, Uniklinikum Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Haemato-oncology patients undergoing chemotherapy treatment for acute or chronic leukemia or lymphoma expected to require a minimum of 1 PC transfusion.
Exclusion criteria
Exclusion criteria: • Pregnancy or history of pregnancy within the last 6 weeks. • Patients suffering from AML type M3 (Acute Promyelocytic Leukemia). • Participation in another clinical trial currently or within the past 28 days. • Splenomegaly (5 cm below the costal margin or > 18 cm in the largest dimension or a palpable spleen) or prior splenectomy. • Active hemorrhage or planned surgery during the study period. • Disseminated intravascular coagulation (DIC). • Temperature higher than 39°C (102.2°F). • Documented prior history or a clinical diagnosis of refractoriness to platelet transfusion (generally defined by at least two successive platelet transfusions with a 1-hour CCI <5,000). • A history or clinical diagnosis of immune thrombocytopenia (ITP), thrombotic thrombocytopenia purpura (TTP), or hemolytic uremic syndrome (HUS). • Current participation in a clinical trial involving the use of another device or drug for pathogen inactivation of platelet components, the use of platelet substitutes, the use of platelet growth factors, or the use of pharmacologic agents to alter platelet hemostatic function. • Received psoralen plus ultraviolet light A (PUVA) therapy or Amphotericin B (Ambisome) therapy in the prior 30 days. • Documented allergy to psoralens.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the fibrin clot formation of conventional or INTERCEPT treated platelet concentrates measured by thromboelastometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Count increments 1 hour after transfusion, count increment 24 hours after transfusion • Corrected count increments 1 hour after transfusion, corrected count increment 24 hours after transfusion • Time to next platelet transfusion • RBC usage | — |
Countries
Germany
Contacts
Public ContactTamam Bakchoul
Institut für klinische und experimentelle Transfusionsmedizin, Uniklinikum Tübingen
Outcome results
None listed