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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00521664

Enrollment

400

Registered

2007-08-28

Start date

2004-09-30

Completion date

2010-09-30

Last updated

2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myeloid Leukemia

Keywords

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

Brief 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.

Interventions

BIOLOGICALProphylactic 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.

BIOLOGICALTherapeutic 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy)	2010

Secondary

Measure	Time frame
- 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026