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TerminatedNCT02276651Updated Jun 8, 2017

Observational Trial of a Therapeutic Platelet Transfusion Regimen

An observational study in Acute Myeloid Leukemia and Thrombocytopenia, sponsored by Klinikum Nürnberg. Terminated at 1 site in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-06-08.

Sponsored by Klinikum Nürnberg · Observational

Why this study was terminated
Insufficient recruitment
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Application of a therapeutic platelet transfusion Regimen in patients with acute myeloid leukemia in complete Remission (consolidation therapy)

Read the detailed description

For the participants a therapeutic regimen for platelet transfusions will be applied: for clinically stable patients platelet Transfusion will be given in case of bleeding WHO II° or higher, for clinically instable patients platelet transfusion will be given at the decretion of the attending physician.

Patients with sepsis, septic shock or infections with Infiltration of organs (e.g. invasive aspergillosis), plasmatic coagulation disorders or sudden or increasing headache with or without neurologic symptoms should receive prophylactic platelet Transfusion, if their platelet Count is less then 10/nl. Otherwise no prophylactic platelet Transfusion will be given irrespective of the actual platelet Count.

As Primary study endpoint The incidence of bleeding episodes WHO grade III an IV will be documented. The bleeding incidence will then be compared to a historic cohort.

02

Conditions studied

  • Acute Myeloid Leukemia
  • Thrombocytopenia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 25 is below the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Klinikum Nürnberg is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute myeloid leukemia in complete remission receiving postremission chemotherapy

Inclusion criteria

  • Acute myeloid leukemia in complete remission

Exclusion criteria

Exclusion Criteria:

  • plasmatic coagulopathy
  • history of severe bleeding complications in chemotherapy induced thrombocytopenia
  • no increment in platelets after platelet transfusion
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Bleeding Grade III and IV (WHO)

    Time frame: Patients will be followed for the phase of thrombocytopenia after chemotherapy, an expected average of about 14 days.

07

Study locations

1 site
  • Klinikum Nurnberg
    Nurnberg, 90419, Germany
08

References and documents

Publications

  • 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. PubMed 22877506 ↗
  • Wandt H, Schafer-Eckart K, Ehninger G. Prophylactic platelet transfusion. N Engl J Med. 2013 Aug 8;369(6):577. doi: 10.1056/NEJMc1307163. No abstract available. PubMed 23924012 ↗
  • Wandt H, Schaefer-Eckart K, Frank M, Birkmann J, Wilhelm M. A therapeutic platelet transfusion strategy is safe and feasible in patients after autologous peripheral blood stem cell transplantation. Bone Marrow Transplant. 2006 Feb;37(4):387-92. doi: 10.1038/sj.bmt.1705246. PubMed 16400342 ↗
  • Wandt H, Frank M, Ehninger G, Schneider C, Brack N, Daoud A, Fackler-Schwalbe I, Fischer J, Gackle R, Geer T, Harms P, Loffler B, Ohl S, Otremba B, Raab M, Schonrock-Nabulsi P, Strobel G, Winter R, Link H. Safety and cost effectiveness of a 10 x 10(9)/L trigger for prophylactic platelet transfusions compared with the traditional 20 x 10(9)/L trigger: a prospective comparative trial in 105 patients with acute myeloid leukemia. Blood. 1998 May 15;91(10):3601-6. PubMed 9572994 ↗
  • Wandt H, Ehninger G, Gallmeier WM. New strategies for prophylactic platelet transfusion in patients with hematologic diseases. Oncologist. 2001;6(5):446-50. doi: 10.1634/theoncologist.6-5-446. PubMed 11675523 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02276651
Lead sponsor
Klinikum Nürnberg
Collaborators
Technische Universität Dresden, University Hospital Heidelberg, Klinikum Chemnitz gGmbH, University Medicine Greifswald
Responsible party
Dr Kerstin Schäfer-Eckart (Principal Investigator, Klinikum Nürnberg) — Principal investigator
First posted
Oct 28, 2014
Start date
Nov 2014
Primary completion
Jun 6, 2017
Completion
Jun 6, 2017
Last update
Jun 8, 2017

Study contacts

Kerstin Schaefer-Eckart, MD
principal investigator · Klinikum Nürnberg

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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