Observational Trial of a Therapeutic Platelet Transfusion Regimen
NCT ID: NCT02276651
Last Updated: 2017-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
25 participants
OBSERVATIONAL
2014-11-30
2017-06-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* history of severe bleeding complications in chemotherapy induced thrombocytopenia
* no increment in platelets after platelet transfusion
18 Years
60 Years
ALL
No
Sponsors
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Technische Universität Dresden
OTHER
University Hospital Heidelberg
OTHER
Klinikum Chemnitz gGmbH
OTHER
University Medicine Greifswald
OTHER
Klinikum Nürnberg
OTHER
Responsible Party
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Dr Kerstin Schäfer-Eckart
Principal Investigator
Principal Investigators
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Kerstin Schaefer-Eckart, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Nürnberg
Locations
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Klinikum Nurnberg
Nuremberg, , Germany
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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