Observational Trial of a Therapeutic Platelet Transfusion Regimen

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ClinicalTrials.gov Identifier: NCT02276651

Recruitment Status : Terminated (Insufficient recruitment)

First Posted : October 28, 2014

Last Update Posted : June 8, 2017

Sponsor:

Collaborators:

Technische Universität Dresden

University Hospital Heidelberg

Klinikum Chemnitz gGmbH

University Medicine Greifswald

Information provided by (Responsible Party):

Dr Kerstin Schäfer-Eckart, Klinikum Nürnberg

Study Description

Brief Summary:

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

Condition or disease
Acute Myeloid Leukemia Thrombocytopenia

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	25 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	A Prospective Multicenter Observational Trial of a Therapeutic Platelet Transfusion Regimen for Patients With Acute Myeloid Leukemia in Consolidation Chemotherapy
Study Start Date :	November 2014
Actual Primary Completion Date :	June 6, 2017
Actual Study Completion Date :	June 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial acute myeloid leukemia with mutated CEBPA Cytogenetically normal acute myeloid leukemia Core binding factor acute myeloid leukemia

MedlinePlus related topics: Acute Myeloid Leukemia Blood Transfusion and Donation Leukemia

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with acute myeloid leukemia in complete remission receiving postremission chemotherapy

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276651

Locations

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Germany
Klinikum Nurnberg
Nurnberg, Germany, 90419

Sponsors and Collaborators

Klinikum Nürnberg

Technische Universität Dresden

University Hospital Heidelberg

Klinikum Chemnitz gGmbH

University Medicine Greifswald

Investigators

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Principal Investigator:	Kerstin Schaefer-Eckart, MD	Klinikum Nürnberg

More Information

Publications:

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, Dölken G, Klenner A, Hänel 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.

Wandt H, Schäfer-Eckart K, Ehninger G. Prophylactic platelet transfusion. N Engl J Med. 2013 Aug 8;369(6):577. doi: 10.1056/NEJMc1307163.

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.

Wandt H, Frank M, Ehninger G, Schneider C, Brack N, Daoud A, Fackler-Schwalbe I, Fischer J, Gäckle R, Geer T, Harms P, Löffler B, Ohl S, Otremba B, Raab M, Schönrock-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.

Wandt H, Ehninger G, Gallmeier WM. New strategies for prophylactic platelet transfusion in patients with hematologic diseases. Oncologist. 2001;6(5):446-50. Review.

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Responsible Party:	Dr Kerstin Schäfer-Eckart, Principal Investigator, Klinikum Nürnberg
ClinicalTrials.gov Identifier:	NCT02276651
Other Study ID Numbers:	001
First Posted:	October 28, 2014 Key Record Dates
Last Update Posted:	June 8, 2017
Last Verified:	June 2017

Additional relevant MeSH terms:

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Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Thrombocytopenia	Neoplasms by Histologic Type Neoplasms Blood Platelet Disorders Hematologic Diseases

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