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

Technische Universität Dresden

Status and phase: Completed; Phase 3

Conditions: Myeloid Leukemia

Treatments: Biological: Therapeutic platelet transfusion; Biological: Prophylactic platelet transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00521664

PEI 1224/01

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Biological: Therapeutic platelet transfusion

2

Active Comparator group

Description:

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.

Treatment:

Biological: Prophylactic platelet transfusion