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

Stephen Esper

Status: Terminated

Conditions: Heart Disease; Lung Disease

Treatments: Device: Thromboelastograph

Study type: Interventional

Funder types: Other

Identifiers

NCT02887820

STUDY19070239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient's requiring ECMO placement

Exclusion criteria

• Other than children less than 18 years of age, no one will be excluded.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Pilot Arm

Other group

Description:

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.

Treatment:

Device: Thromboelastograph