NCT00521664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 19, 2011

Status Verified

May 1, 2011

Enrollment Period

6 years

First QC Date

August 27, 2007

Last Update Submit

May 18, 2011

Conditions

Myeloid Leukemia

Keywords

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

Outcome Measures

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)

    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

    2010

Study Arms (2)

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

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

Interventions

Prophylactic platelet transfusionBIOLOGICAL

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.

2
Therapeutic platelet transfusionBIOLOGICAL

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.

1

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • AML project
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nuremberg, 90419, Germany

Location

Related Publications (1)

  • Wandt H, Schaefer-Eckart K, Wendelin K, Pilz B, Wilhelm M, Thalheimer M, Mahlknecht U, Ho A, Schaich M, Kramer M, Kaufmann M, Leimer L, Schwerdtfeger R, Conradi R, Dolken G, Klenner A, Hanel M, Herbst R, Junghanss C, Ehninger G; Study Alliance Leukemia. Therapeutic platelet transfusion versus routine prophylactic transfusion in patients with haematological malignancies: an open-label, multicentre, randomised study. Lancet. 2012 Oct 13;380(9850):1309-16. doi: 10.1016/S0140-6736(12)60689-8. Epub 2012 Aug 8.

    PMID: 22877506DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Gerhard Ehninger, Prof.

    University Hospital Carl Gustav Carus Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2007

First Posted

August 28, 2007

Study Start

September 1, 2004

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 19, 2011

Record last verified: 2011-05

Locations

DE(1)