Evaluating the Use of Thromboelastography (TEG) in Patient's Requiring Extracorporeal Membrane Oxygenation (ECMO)

Study Overview
=================
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.

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)

Conditions
-----------------
Heart Disease, Lung Disease

Intervention / Treatment
-----------------
* Device: Thromboelastograph


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's requiring ECMO placement Exclusion Criteria: Other than children less than 18 years of age, no one will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pilot Arm<br>All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm. | Device: Thromboelastograph<br>* A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions<br>* Other names: TEG 5000;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants whose blood management care follows a TEG algorithm 90% of the time |  | From time patient is placed on ECMO to 30-days post ECMO initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of transfusions required while on ECMO |  | From the time patient is placed on ECMO to 30-days post ECMO initiation | 
| Number of participants that experience bleeding or thrombotic-related adverse events, including deep venous thrombosis or pulmonary embolus |  | From the time patient is placed on ECMO to 30-days post ECMO initiation | 
| Chest tube output and overall estimated blood loss |  | From time patient is placed on ECMO to 30-days post ECMO initiation | 
| Time between transfusions |  | From time patient is placed on ECMO to 30-days post ECMO initiation | 
| Type of blood products transfused |  | From time patient is placed on ECMO to 30-days post ECMO initiation | 
| Pump exchanges required |  | From time patient is placed on ECMO to 30-days post ECMO initiation | 
| Oxygenator exchanges |  | From time patient is placed on ECMO to 30-days post ECMO initiation | 
| Occurrence of pump circuit clotting and clots in the oxygenator (visible clot which did not require circuit/pump exchange) |  | From time patient is placed on ECMO to 30-days post ECMO initiation | 
| Time to weaning from/removal of ECMO |  | From time patient is placed on ECMO until time to weaning from ECMO | 
| Need for surgical intervention for hemorrhage |  | From time patient is placed on ECMO to 30-days post ECMO initiation | 
| Specimen turn around time for lab tests (CBC, ACT, PT, PTT, anti-Xa, INR, platelet count) and TEG results |  | From time patient is placed on ECMO to 30-days post ECMO initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECMO, TEG