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

NCT02887820 | Terminated Results FDA Device

• 1 other identifier: STUDY19070239
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease; Lung Disease

Keywords

ECMO; TEG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (1)

Pilot Arm

OTHER

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

Interventions

Thromboelastograph DEVICE

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

Also known as: TEG 5000

Pilot Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's requiring ECMO placement

You may not qualify if:

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

Sponsors & Collaborators

• Stephen Esper: lead
• American Heart Association: collaborator

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (8)

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

  PMID: 19767408 RESULT

• 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.

  PMID: 15507261 RESULT

• 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.

  PMID: 10564301 RESULT

• 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.

  PMID: 12680494 RESULT

• 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.

  PMID: 8039220 RESULT

• 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.

  PMID: 7983877 RESULT

• 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.

  PMID: 21412912 RESULT

• 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.

  PMID: 9972747 RESULT

MeSH Terms

Conditions

Heart Diseases; Lung Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Amy Monroe
• Organization: University of Pittsburgh

monroeal@upmc.edu

412-623-6382

Study Officials

• Stephen Esper, MD, MBA

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Chief of Perioperative Services

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 2, 2016
• Study Start: December 15, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 31, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)