Observational Trial of a Therapeutic Platelet Transfusion Regimen

NCT02276651 | Terminated DMC

• 1 other identifier: 001
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Myeloid Leukemia; Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Bleeding Grade III and IV (WHO)

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute myeloid leukemia in complete remission receiving postremission chemotherapy

You may qualify if:

• Acute myeloid leukemia in complete remission

You may not qualify if:

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

Sponsors & Collaborators

• Klinikum Nürnberg: lead
• Technische Universität Dresden: collaborator
• University Hospital Heidelberg: collaborator
• Klinikum Chemnitz gGmbH: collaborator
• University Medicine Greifswald: collaborator

Study Sites (1)

Klinikum Nurnberg

Nuremberg, 90419, Germany

Location

Related Publications (5)

• 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: 22877506 BACKGROUND

• 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.

  PMID: 23924012 BACKGROUND

• 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.

  PMID: 16400342 BACKGROUND

• 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.

  PMID: 9572994 BACKGROUND

• 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.

  PMID: 11675523 BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Thrombocytopenia

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Platelet Disorders; Cytopenia

Study Officials

• Kerstin Schaefer-Eckart, MD

  Klinikum Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 28, 2014
• Study Start: November 1, 2014
• Primary Completion: June 6, 2017
• Study Completion: June 6, 2017
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

DE (1)