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

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.

Study Overview

• Status: Completed
• Conditions: Heart Disease; Lung Disease
• Intervention / Treatment: Device: Thromboelastograph

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy L Monroe, BS; Phone Number: 412-609-6161; Email: monroeal@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient's requiring ECMO placement

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Pilot Arm; 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; A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions; Other Names: TEG 5000

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Stephen Esper
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Stephen Esper, MD, MBA, University of Pittsburgh Medical Center

Publications and helpful links

General Publications

• Oliver WC. Anticoagulation and coagulation management for ECMO. Semin Cardiothorac Vasc Anesth. 2009 Sep;13(3):154-75. doi: 10.1177/1089253209347384.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimated): September 2, 2016

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ECMO; TEG
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Heart Diseases; Lung Diseases
• Other Study ID Numbers: STUDY19070239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes