Observational Trial of a Therapeutic Platelet Transfusion... | NCT02276651

Studies
Observational Trial of a Therapeutic Platelet Transfusion Regimen

NCT02276651

Sponsor

Klinikum Nürnberg

Status

Terminated

Last Update Posted

Jun 8, 2017Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Acute Myeloid Leukemia
Thrombocytopenia

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Jun 6, 2017Actual

Completion Date

Jun 6, 2017Actual

First Submitted Date

Oct 22, 2014

First Submission Date that Met QC Criteria

Oct 27, 2014

First Posted Date

Oct 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2017

Last Update Posted Date

Jun 8, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Kerstin Schäfer-Eckart, Principal Investigator, Klinikum NürnbergPrincipal Investigator

Lead Sponsor

Klinikum NürnbergOTHER

Collaborators

Name	Class
Technische Universität Dresden	OTHER
University Hospital Heidelberg	OTHER
Klinikum Chemnitz gGmbH	OTHER
University Medicine Greifswald

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patients with acute myeloid leukemia in complete remission receiving postremission chemotherapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kerstin Schaefer-Eckart, MD	Klinikum Nürnberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Nurnberg		Nuremberg		90419	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22877506	Background	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.
23924012

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D015470	Leukemia, Myeloid, Acute
D013921	Thrombocytopenia