Observational Trial of a Therapeutic Platelet Transfusion Regimen

June 7, 2017 updated by: Dr Kerstin Schäfer-Eckart, Klinikum Nürnberg

A Prospective Multicenter Observational Trial of a Therapeutic Platelet Transfusion Regimen for Patients With Acute Myeloid Leukemia in Consolidation Chemotherapy

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

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Nurnberg, Germany, 90419
        • Klinikum Nürnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute myeloid leukemia in complete remission receiving postremission chemotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Patients will be followed for the phase of thrombocytopenia after chemotherapy, an expected average of about 14 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum Nürnberg

Collaborators

University Medicine Greifswald
University Hospital Heidelberg
Technische Universität Dresden
Klinikum Chemnitz gGmbH

Investigators

  • Principal Investigator: Kerstin Schaefer-Eckart, MD, Klinikum Nürnberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

June 6, 2017

Study Completion (Actual)

June 6, 2017

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 28, 2014

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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