A Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups - Full Text View

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00521664

Purpose

The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e. platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without any sign of bleeding when the platelet count is below 10.000/µL). With the experimental transfusion strategy transfusions could be safely reduced when the study hypothesis can be proven. This is the first prospective randomized study on this topic.

Condition	Intervention	Phase
Myeloid Leukemia	Biological: Prophylactic platelet transfusion Biological: Therapeutic platelet transfusion	Phase III

MedlinePlus related topics: Blood Transfusion and Donation Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Prospective Randomized Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups: 1)in Patients With Acute Myeloid Leukemia After Intensive Chemotherapy and 2) After Autologous Blood Stem Cell Transplantation

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- incidence and duration of clinically relevant bleeding - numbers of red blood cell transfusion - side effects of transfusions - duration of thrombocytopenia below 10.000/µL and below 20.000/µL - duration of hospitalisation [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	September 2004
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Therapeutic platelet transfusion (TP) strategy versus prophylactic platelet transfusion (PP) strategy. In the TP arm platelet transfusion is only required if bleeding occurs (more than petechial)or in case of pulmonary infections with or without sepsis.	Biological: Therapeutic platelet transfusion In the TP arm platelet transfusion is only required if bleeding occurs (more than petechial)or in case of pulmonary infections with or without sepsis.
2: Active Comparator In the PP arm platelet transfusion has to be performed when platelet count is below 10.000/µL in any case and when bleeding (more than petechial) occurs.	Biological: Prophylactic platelet transfusion In the PP arm platelet transfusion has to be performed when platelet count is below 10.000/µL in any case and when bleeding (more than petechial) occurs.

Eligibility

Ages Eligible for Study:	16 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

AML project

inclusion in studies of the DSIL or OSHO group for AML
AML M3/M3v can be included only when in complete remission
age 16 - 80 years
written informed consent

Autologous project

AMl and ALL patients in first or second remission
low grade or high grade non hodgkin lymphoma or morbus hodgkin or multiple myeloma
conditioning regime: TBI 8-12 Gy/Cy 120 or BEAM or BU/CY or Melphalan 140-200mg/m2 or a similarly intensive chemotherapy regime
age 16 - 65 years

Exclusion Criteria:

AML project

known refractoriness to platelet transfusion
known major bleeding with thrombocytopenia when the reason for bleeding is still ongoing
known plasmatic coagulation disorder
patient unable to give informed consent

Autologous project

known refractoriness to platelet transfusion
known major bleeding with thrombocytopenia when the reason for bleeding is still ongoing
known plasmatic coagulation disorder
patient unable to give informed consent
patients with pulmonal or cerebral lesions due to infection or neoplasm
patients with al-amyloidosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521664

Contacts

Contact: Hannes Wandt, Dr. MD	0911/398 ext 3650	wandt@klinikum-nuernberg.de
Contact: Kerstin Schäfer-Eckart, Dr.	0911/398 ext 3650	schaefer@klinikum-nuernberg.de

Locations

Germany
Klinikum Nürnberg Nord; Einheit für Knochenmarktransplantation; 5. Med. Klinik	Recruiting
Nürnberg, Germany, 90419
Contact: Hannes Wandt, Dr. MD 0911-398 ext 3650 wandt@klinikum-nuernberg.de

Sponsors and Collaborators

Dresden University of Technology

Investigators

Principal Investigator:

Gerhard Ehninger, Prof.

University Hospital Carl Gustav Carus Dresden

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Dresden University of Technology ( Katrin Peschel )
Study ID Numbers:	PEI 1224/01
Study First Received:	August 27, 2007
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00521664
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

proof of safety and cost effectiveness of the new therapeutic platelet transfusion strategy

Study placed in the following topic categories:

Leukemia
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009