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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Number of Participants Whose Blood Management Care Follows a TEG Algorithm 90% of the Time
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation
Number of Transfusions Required While on ECMO
Number of patients who required transfusions
Time frame: 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
Number of patients who experienced bleeding while on ECMO
Time frame: From the time patient is placed on ECMO to 30-days post ECMO initiation
Chest Tube Output and Overall Estimated Blood Loss
Average chest tube output
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation
Time Between Transfusions
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation
Type of Blood Products Transfused
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation
Pump Exchanges Required
Number of participants who required pump exchanges
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation
Oxygenator Exchanges
NUmber of participants who required oxygenator exchanges while on ECMO
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Time frame: 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)
Number of participants with pump circuit clotting
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation
Time to Weaning From/Removal of ECMO
Average time to ECMO removal
Time frame: From time patient is placed on ECMO until time to weaning from ECMO
Need for Surgical Intervention for Hemorrhage
Number of participants
Time frame: 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
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation