Observational Trial of a Therapeutic Platelet Transfusion Regimen

Acute Myeloid Leukemia Clinical Trial

Official title:

A Prospective Multicenter Observational Trial of a Therapeutic Platelet Transfusion Regimen for Patients With Acute Myeloid Leukemia in Consolidation Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02276651
• Other study ID #: 001
• Status: Terminated
• Phase: N/A
• First received: October 22, 2014
• Last updated: June 7, 2017
• Start date: November 2014
• Est. completion date: June 6, 2017

Study information

• Verified date: June 2017
• Source: Klinikum Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 6, 2017
• Est. primary completion date: June 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Acute myeloid leukemia in complete remission

Exclusion Criteria:

• plasmatic coagulopathy

• history of severe bleeding complications in chemotherapy induced thrombocytopenia

• no increment in platelets after platelet transfusion

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Thrombocytopenia

Locations

Country	Name	City	State
Germany	Klinikum Nurnberg	Nurnberg

Sponsors (5)

Lead Sponsor	Collaborator
Klinikum Nürnberg	Klinikum Chemnitz gGmbH, Technische Universität Dresden, University Hospital Heidelberg, University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Wandt H, Ehninger G, Gallmeier WM. New strategies for prophylactic platelet transfusion in patients with hematologic diseases. Oncologist. 2001;6(5):446-50. Review. — View Citation

Wandt H, Frank M, Ehninger G, Schneider C, Brack N, Daoud A, Fackler-Schwalbe I, Fischer J, Gäckle R, Geer T, Harms P, Löffler B, Ohl S, Otremba B, Raab M, Schönrock-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. — View Citation

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. — View Citation

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, Dölken G, Klenner A, Hänel 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. — View Citation

Wandt H, Schäfer-Eckart K, Ehninger G. Prophylactic platelet transfusion. N Engl J Med. 2013 Aug 8;369(6):577. doi: 10.1056/NEJMc1307163#SA1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding Grade III and IV (WHO)		Patients will be followed for the phase of thrombocytopenia after chemotherapy, an expected average of about 14 days.