Clinical trial NCT02887820: Evaluating the Use of Thromboelastography (TEG) in Patient's Requiring Extracorporeal Membrane Oxygenation (ECMO)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Disease
Lung Disease
Keywords: ECMO
TEG
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2016-09-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of Participants Whose Blood Management Care Follows a TEG Algorithm 90% of the Time
timeFrame: From time patient is placed on ECMO to 30-days post ECMO initiation
Secondary outcomes:
measure: Number of Transfusions Required While on ECMO
timeFrame: From the time patient is placed on ECMO to 30-days post ECMO initiation
measure: Number of Participants That Experience Bleeding or Thrombotic-related Adverse Events, Including Deep Venous Thrombosis or Pulmonary Embolus
timeFrame: From the time patient is placed on ECMO to 30-days post ECMO initiation
measure: Chest Tube Output and Overall Estimated Blood Loss
timeFrame: From time patient is placed on ECMO to 30-days post ECMO initiation
measure: Time Between Transfusions
timeFrame: From time patient is placed on ECMO to 30-days post ECMO initiation
measure: Type of Blood Products Transfused
timeFrame: From time patient is placed on ECMO to 30-days post ECMO initiation
measure: Pump Exchanges Required
timeFrame: From time patient is placed on ECMO to 30-days post ECMO initiation
measure: Oxygenator Exchanges
timeFrame: From time patient is placed on ECMO to 30-days post ECMO initiation
measure: Occurrence of Pump Circuit Clotting and Clots in the Oxygenator (Visible Clot Which Did Not Require Circuit/Pump Exchange)
timeFrame: From time patient is placed on ECMO to 30-days post ECMO initiation
measure: Time to Weaning From/Removal of ECMO
timeFrame: From time patient is placed on ECMO until time to weaning from ECMO
measure: Need for Surgical Intervention for Hemorrhage
timeFrame: From time patient is placed on ECMO to 30-days post ECMO initiation
measure: Specimen Turn Around Time for Lab Tests (CBC, ACT, PT, PTT, Anti-Xa, INR, Platelet Count) and TEG Results
timeFrame: From time patient is placed on ECMO to 30-days post ECMO initiation
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Stephen Esper, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oliver WC. Anticoagulation and coagulation management for ECMO. Semin Cardiothorac Vasc Anesth. 2009 Sep;13(3):154-75. doi: 10.1177/1089253209347384.
citation: Esmon CT. The impact of the inflammatory response on coagulation. Thromb Res. 2004;114(5-6):321-7. doi: 10.1016/j.thromres.2004.06.028.
citation: Muntean W. Coagulation and anticoagulation in extracorporeal membrane oxygenation. Artif Organs. 1999 Nov;23(11):979-83. doi: 10.1046/j.1525-1594.1999.06451.x.
citation: Colby CE, Sheehan A, Benitz W, Van Meurs K, Halamek LP, Moss RL. Maintaining adequate anticoagulation on extracorporeal membrane oxygenation therapy: Hemochron Junior Low Range versus Hemochron 400. J Extra Corpor Technol. 2003 Mar;35(1):35-8.
citation: Reiner JS, Coyne KS, Lundergan CF, Ross AM. Bedside monitoring of heparin therapy: comparison of activated clotting time to activated partial thromboplastin time. Cathet Cardiovasc Diagn. 1994 May;32(1):49-52. doi: 10.1002/ccd.1810320112.
citation: Despotis GJ, Summerfield AL, Joist JH, Goodnough LT, Santoro SA, Spitznagel E, Cox JL, Lappas DG. Comparison of activated coagulation time and whole blood heparin measurements with laboratory plasma anti-Xa heparin concentration in patients having cardiac operations. J Thorac Cardiovasc Surg. 1994 Dec;108(6):1076-82.
citation: Afshari A, Wikkelso A, Brok J, Moller AM, Wetterslev J. Thrombelastography (TEG) or thromboelastometry (ROTEM) to monitor haemotherapy versus usual care in patients with massive transfusion. Cochrane Database Syst Rev. 2011 Mar 16;(3):CD007871. doi: 10.1002/14651858.CD007871.pub2.
citation: Shore-Lesserson L, Manspeizer HE, DePerio M, Francis S, Vela-Cantos F, Ergin MA. Thromboelastography-guided transfusion algorithm reduces transfusions in complex cardiac surgery. Anesth Analg. 1999 Feb;88(2):312-9. doi: 10.1097/00000539-199902000-00016.