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Heart DiseaseNCT02887820

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

A study testing Thromboelastograph in people with Heart Disease and Lung Disease, run by Stephen Esper at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Disease, Lung Disease
What is being tested?
Thromboelastograph
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
15 Dec 2017to 31 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient's requiring ECMO placement

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
Thromboelastograph
Keywords
ECMO, TEG
Medical subject headings
Heart Diseases, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThromboelastographDevice

    Also called TEG 5000

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

Study groups in NCT02887820
Study groupRoleWhat they receive
Pilot ArmOtherAll 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.
Receives: Device: Thromboelastograph

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Whose Blood Management Care Follows a TEG Algorithm 90% of the Time

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

Secondary outcomes (11)

  1. Number of Transfusions Required While on ECMO

    Number of patients who required transfusions

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

  2. Number of Participants That Experience Bleeding or Thrombotic-related Adverse Events, Including Deep Venous Thrombosis or Pulmonary Embolus

    Number of patients who experienced bleeding while on ECMO

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

  3. Chest Tube Output and Overall Estimated Blood Loss

    Average chest tube output

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

  4. Time Between Transfusions

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

  5. Type of Blood Products Transfused

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

  6. Pump Exchanges Required

    Number of participants who required pump exchanges

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

  7. Oxygenator Exchanges

    NUmber of participants who required oxygenator exchanges while on ECMO

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

  8. Occurrence of Pump Circuit Clotting and Clots in the Oxygenator (Visible Clot Which Did Not Require Circuit/Pump Exchange)

    Number of participants with pump circuit clotting

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

  9. Time to Weaning From/Removal of ECMO

    Average time to ECMO removal

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

  10. Need for Surgical Intervention for Hemorrhage

    Number of participants

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

  11. Specimen Turn Around Time for Lab Tests (CBC, ACT, PT, PTT, Anti-Xa, INR, Platelet Count) and TEG Results

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2016 (estimated)
  2. Study start15 Dec 2017
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Why it stopped: A new standard of care was introduced making it impossible to continue with the study. Additionally, some of the blood product and transfusion related outcomes were not collected because this data was not present in the EMR.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02887820
Sponsor's protocol ID
STUDY19070239
Status last verified
May 2025
First submitted
25 Aug 2016
Last updated
31 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

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

    PubMed 19767408

  • 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.

    PubMed 15507261

  • 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.

    PubMed 10564301

  • 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.

    PubMed 12680494

  • 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.

    PubMed 8039220

  • 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.

    PubMed 7983877

  • 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.

    PubMed 21412912

  • 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.

    PubMed 9972747

Questions about this trial

What is this clinical trial studying?

A study testing Thromboelastograph in people with Heart Disease and Lung Disease, run by Stephen Esper at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02887820, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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