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

Primary Purpose

Heart Disease, Lung Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Thromboelastograph

About this trial

This is an interventional supportive care trial for Heart Disease focused on measuring ECMO, TEG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

UPMC Presbyterian HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pilot Arm

Arm 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.

Outcomes

Primary Outcome Measures

Number of participants whose blood management care follows a TEG algorithm 90% of the time

Secondary Outcome Measures

Number of transfusions required while on ECMO

Number of participants that experience bleeding or thrombotic-related adverse events, including deep venous thrombosis or pulmonary embolus

Chest tube output and overall estimated blood loss

Time between transfusions

Type of blood products transfused

Pump exchanges required

Oxygenator exchanges

Occurrence of pump circuit clotting and clots in the oxygenator (visible clot which did not require circuit/pump exchange)

Time to weaning from/removal of ECMO

Need for surgical intervention for hemorrhage

Specimen turn around time for lab tests (CBC, ACT, PT, PTT, anti-Xa, INR, platelet count) and TEG results

Full Information

NCT ID

NCT02887820

First Posted

August 25, 2016

Last Updated

May 2, 2023

Sponsor

Stephen Esper

Collaborators

American Heart Association

1. Study Identification

Unique Protocol Identification Number

NCT02887820

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 15, 2017 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Stephen Esper

Collaborators

American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Disease, Lung Disease

Keywords

ECMO, TEG

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pilot Arm

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Thromboelastograph

Other Intervention Name(s)

TEG 5000

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Number of transfusions required while on ECMO

Time Frame

From the time patient is placed on ECMO to 30-days post ECMO initiation

Title

Number of participants that experience bleeding or thrombotic-related adverse events, including deep venous thrombosis or pulmonary embolus

Time Frame

From the time patient is placed on ECMO to 30-days post ECMO initiation

Title

Chest tube output and overall estimated blood loss

Time Frame

From time patient is placed on ECMO to 30-days post ECMO initiation

Title

Time between transfusions

Time Frame

From time patient is placed on ECMO to 30-days post ECMO initiation

Title

Type of blood products transfused

Time Frame

From time patient is placed on ECMO to 30-days post ECMO initiation

Title

Pump exchanges required

Time Frame

From time patient is placed on ECMO to 30-days post ECMO initiation

Title

Oxygenator exchanges

Time Frame

From time patient is placed on ECMO to 30-days post ECMO initiation

Title

Occurrence of pump circuit clotting and clots in the oxygenator (visible clot which did not require circuit/pump exchange)

Time Frame

From time patient is placed on ECMO to 30-days post ECMO initiation

Title

Time to weaning from/removal of ECMO

Time Frame

From time patient is placed on ECMO until time to weaning from ECMO

Title

Need for surgical intervention for hemorrhage

Time Frame

From time patient is placed on ECMO to 30-days post ECMO initiation

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amy L Monroe, BS

Phone

412-609-6161

monroeal@upmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Esper, MD, MBA

Organizational Affiliation

University of Pittsburgh Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC Presbyterian Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amy L Monroe, BS

Phone

412-609-6161

monroeal@upmc.edu

First Name & Middle Initial & Last Name & Degree

Kathirvel Subramaniam, MD, MPH

First Name & Middle Initial & Last Name & Degree

Arthur J Boujoukos, MD

First Name & Middle Initial & Last Name & Degree

Boisen Michael, MD

First Name & Middle Initial & Last Name & Degree

Stephen Esper, MD, MBA

First Name & Middle Initial & Last Name & Degree

D'Cunha Jonathan, MD

First Name & Middle Initial & Last Name & Degree

Hayanga Jeremiah, MD

First Name & Middle Initial & Last Name & Degree

Kormos Robert, MD

First Name & Middle Initial & Last Name & Degree

Lagazzi Luigi, MD

First Name & Middle Initial & Last Name & Degree

Sappington Penny, MD

First Name & Middle Initial & Last Name & Degree

Triulzi Darrell, MD

First Name & Middle Initial & Last Name & Degree

Waters Jonathan, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19767408

Citation

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

Results Reference

result

PubMed Identifier

15507261

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.

Results Reference

result

PubMed Identifier

10564301

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.

Results Reference

result

PubMed Identifier

12680494

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.

Results Reference

result

PubMed Identifier

8039220

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.

Results Reference

result

PubMed Identifier

7983877

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.

Results Reference

result

PubMed Identifier

21412912

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.

Results Reference

result

PubMed Identifier

9972747

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.

Results Reference

result

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

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