Clinical trial NCT02276651: Observational Trial of a Therapeutic Platelet Transfusion Regimen
Official title: A Prospective Multicenter Observational Trial of a Therapeutic Platelet Transfusion Regimen for Patients With Acute Myeloid Leukemia in Consolidation Chemotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Myeloid Leukemia
Thrombocytopenia
Lead sponsor: Klinikum Nürnberg
Sponsor class: OTHER
Collaborators: name: Technische Universität Dresden
name: University Hospital Heidelberg
name: Klinikum Chemnitz gGmbH
name: University Medicine Greifswald
First posted: 2014-10-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute myeloid leukemia in complete remission receiving postremission chemotherapy

Brief 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.

Eligibility 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

Primary outcomes:
measure: Bleeding Grade III and IV (WHO)
timeFrame: Patients will be followed for the phase of thrombocytopenia after chemotherapy, an expected average of about 14 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Nurnberg
country: Germany
facility: Klinikum Nurnberg
Study officials:
affiliation: Klinikum Nürnberg
name: Kerstin Schaefer-Eckart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wandt H, Schaefer-Eckart K, Wendelin K, Pilz B, Wilhelm M, Thalheimer M, Mahlknecht U, Ho A, Schaich M, Kramer M, Kaufmann M, Leimer L, Schwerdtfeger R, Conradi R, Dolken G, Klenner A, Hanel M, Herbst R, Junghanss C, Ehninger G; Study Alliance Leukemia. Therapeutic platelet transfusion versus routine prophylactic transfusion in patients with haematological malignancies: an open-label, multicentre, randomised study. Lancet. 2012 Oct 13;380(9850):1309-16. doi: 10.1016/S0140-6736(12)60689-8. Epub 2012 Aug 8.
citation: Wandt H, Schafer-Eckart K, Ehninger G. Prophylactic platelet transfusion. N Engl J Med. 2013 Aug 8;369(6):577. doi: 10.1056/NEJMc1307163. No abstract available.
citation: Wandt H, Schaefer-Eckart K, Frank M, Birkmann J, Wilhelm M. A therapeutic platelet transfusion strategy is safe and feasible in patients after autologous peripheral blood stem cell transplantation. Bone Marrow Transplant. 2006 Feb;37(4):387-92. doi: 10.1038/sj.bmt.1705246.
citation: Wandt H, Frank M, Ehninger G, Schneider C, Brack N, Daoud A, Fackler-Schwalbe I, Fischer J, Gackle R, Geer T, Harms P, Loffler B, Ohl S, Otremba B, Raab M, Schonrock-Nabulsi P, Strobel G, Winter R, Link H. Safety and cost effectiveness of a 10 x 10(9)/L trigger for prophylactic platelet transfusions compared with the traditional 20 x 10(9)/L trigger: a prospective comparative trial in 105 patients with acute myeloid leukemia. Blood. 1998 May 15;91(10):3601-6.
citation: Wandt H, Ehninger G, Gallmeier WM. New strategies for prophylactic platelet transfusion in patients with hematologic diseases. Oncologist. 2001;6(5):446-50. doi: 10.1634/theoncologist.6-5-446.