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NCT Number: NCT00521664

A Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups

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.

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Key information

Conditions

Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Neoplasms Neoplasms by Histologic Type

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinikum Nürnberg Nord; Einheit für Knochenmarktransplantation; 5. Med. Klinik

Nuremberg, 90419, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic platelet transfusion

Biological

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.

Therapeutic platelet transfusion

Biological

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. - 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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Aug 28, 2007
Registry last updated
May 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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