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

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ClinicalTrials.gov Identifier: NCT02887820
Recruitment Status : Recruiting
First Posted : September 2, 2016
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Stephen Esper, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Heart Disease Lung Disease Device: Thromboelastograph Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: TEG 5000




Primary Outcome Measures :
  1. 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 Measures :
  1. Number of transfusions required while on ECMO [ Time Frame: 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 [ Time Frame: From the time patient is placed on ECMO to 30-days post ECMO initiation ]
  3. Chest tube output and overall estimated blood loss [ Time Frame: From time patient is placed on ECMO to 30-days post ECMO initiation ]
  4. Time between transfusions [ Time Frame: From time patient is placed on ECMO to 30-days post ECMO initiation ]
  5. Type of blood products transfused [ Time Frame: From time patient is placed on ECMO to 30-days post ECMO initiation ]
  6. Pump exchanges required [ Time Frame: From time patient is placed on ECMO to 30-days post ECMO initiation ]
  7. Oxygenator exchanges [ Time Frame: 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) [ Time Frame: From time patient is placed on ECMO to 30-days post ECMO initiation ]
  9. Time to weaning from/removal of ECMO [ Time Frame: From time patient is placed on ECMO until time to weaning from ECMO ]
  10. Need for surgical intervention for hemorrhage [ Time Frame: 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 [ Time Frame: From time patient is placed on ECMO to 30-days post ECMO initiation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient's requiring ECMO placement

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887820


Contacts
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Contact: Amy L Monroe, BS 412-609-6161 monroeal@upmc.edu

Locations
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United States, Pennsylvania
UPMC Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Amy L Monroe, BS    412-609-6161    monroeal@upmc.edu   
Principal Investigator: Kathirvel Subramaniam, MD, MPH         
Sub-Investigator: Arthur J Boujoukos, MD         
Sub-Investigator: Boisen Michael, MD         
Principal Investigator: Stephen Esper, MD, MBA         
Sub-Investigator: D'Cunha Jonathan, MD         
Sub-Investigator: Hayanga Jeremiah, MD         
Sub-Investigator: Kormos Robert, MD         
Sub-Investigator: Lagazzi Luigi, MD         
Sub-Investigator: Sappington Penny, MD         
Sub-Investigator: Triulzi Darrell, MD         
Sub-Investigator: Waters Jonathan, MD         
Sponsors and Collaborators
Stephen Esper
American Heart Association
Investigators
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Principal Investigator: Stephen Esper, MD, MBA University of Pittsburgh Medical Center

Publications of Results:

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Responsible Party: Stephen Esper, Assistant Professor of Anesthesiology, Chief of Perioperative Services, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02887820     History of Changes
Other Study ID Numbers: PRO16060542
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Stephen Esper, University of Pittsburgh:
ECMO
TEG
Additional relevant MeSH terms:
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Lung Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases