Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-01 @ 4:12 PM
Study NCT ID:
NCT02887820
Status:
TERMINATED
Last Update Posted:
2025-05-31
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Use of Thromboelastography (TEG) in Patient's Requiring Extracorporeal Membrane Oxygenation (ECMO)
Sponsor:
Stephen Esper
Organization:
Study Overview
Official Title:
A Pilot Study in Feasibility and Safety: Point of Care Testing With Thromboelastography (TEG) for Blood Product Transfusion in Patient's Requiring Extracorporeal Membrane Oxygenation (ECMO)
Status:
TERMINATED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
A new standard of care was introduced making it impossible to continue with the study. Additionally, some of the blood product and transfusion related outcomes were not collected because this data was not present in the EMR.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study that seeks to evaluate the feasibility and safety of using a TEG algorithm in addition to traditional laboratory tests to guide transfusion and coagulation management of ECMO patients.
Detailed Description:
All adult patients requiring ECMO will be considered for the trial, with a target enrollment of 50 participants over a two-year period. For each enrolled participant, a TEG transfusion algorithm will be followed for patients exhibiting inadequate hemostasis in the operating room (Flowchart 1). Once patient has a normal TEG result with adequate hemostasis, either heparin or bivalirudin will be used as the anticoagulant. If patients are receiving no anticoagulation or heparin anticoagulation then a second TEG algorithm will be followed in the ICU when hemostasis is normal and heparin is introduced (Flowchart 2). If patients are receiving bivalirudin as their anticoagulation strategy, the transfusion parameters with TEG application will not apply. In addition to determining the compliance and feasibility of following these TEG algorithms, clinical outcome data including transfusion rates, types of blood products transfused, estimated blood loss and thrombotic events will be collected for every enrolled patient until they are discontinued from ECMO. Statistical analysis of the primary, secondary and tertiary endpoints of this study will determine the likelihood of exploring future clinical trials involving TEG-driven coagulation and transfusion management of the ECMO population.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: