Evaluating the Use of Thromboelastography (TEG) in Patient's Requiring Extracorporeal Membrane Oxygenation (ECMO)
Status: | Recruiting |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology, Pulmonary |
Therapuetic Areas: | Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/12/2019 |
Start Date: | December 15, 2017 |
End Date: | February 2019 |
Contact: | Amy L Monroe, BS |
Email: | monroeal@upmc.edu |
Phone: | 412-609-6161 |
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)
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.
algorithm in addition to traditional laboratory tests to guide transfusion and coagulation
management of ECMO patients.
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.
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.
Inclusion Criteria:
- Patient's requiring ECMO placement
Exclusion Criteria:
- Other than children less than 18 years of age, no one will be excluded.
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Principal Investigator: Kathirvel Subramaniam, MD, MPH
Phone: 412-609-6161
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