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Observational Trial of a Therapeutic Platelet Transfusion Regimen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

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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





Primary Outcome Measures :
  1. 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. ]


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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

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
Publications:

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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