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

Heart Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887820
• Other study ID #: STUDY19070239
• Status: Completed
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient's requiring ECMO placement

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases
• Lung Disease
• Lung Diseases

Intervention

Device:
• Thromboelastograph
A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions

Locations

Country	Name	City	State
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Stephen Esper	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (8)

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: 10.10 — View 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. — View 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 — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of transfusions required while on ECMO		From the time patient is placed on ECMO to 30-days post ECMO initiation
Secondary	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
Secondary	Chest tube output and overall estimated blood loss		From time patient is placed on ECMO to 30-days post ECMO initiation
Secondary	Time between transfusions		From time patient is placed on ECMO to 30-days post ECMO initiation
Secondary	Type of blood products transfused		From time patient is placed on ECMO to 30-days post ECMO initiation
Secondary	Pump exchanges required		From time patient is placed on ECMO to 30-days post ECMO initiation
Secondary	Oxygenator exchanges		From time patient is placed on ECMO to 30-days post ECMO initiation
Secondary	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
Secondary	Time to weaning from/removal of ECMO		From time patient is placed on ECMO until time to weaning from ECMO
Secondary	Need for surgical intervention for hemorrhage		From time patient is placed on ECMO to 30-days post ECMO initiation
Secondary	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