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

Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521664
• Other study ID #: PEI 1224/01
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2007
• Last updated: May 18, 2011
• Start date: September 2004
• Est. completion date: September 2010

Study information

• Verified date: May 2011
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia, Myeloid
• Myeloid Leukemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Klinikum Nürnberg Nord; Einheit für Knochenmarktransplantation; 5. Med. Klinik	Nürnberg

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy)		2010	No
Secondary	- 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		2010	No

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