Thrombo-Elastography Guided Management of ECMO

NCT04268940 | Completed

• 1 other identifier: 19-5121
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Anticoagulation and coagulation management during ECMO is a challenge. Bleeding and clotting are major sources of morbidity and mortality. The currently used strategies are of poor evidence. This observational study wants to evaluate the use of automated thromboelastography (TEG 6s) to guide the management of coagulation and anticoagulation in patients supported by ECMO

Conditions

Extracorporeal Circulation of Blood; Thrombocytopenia

Keywords

Unfractionated heparin; Extracorporeal Membrane Oxygenation (ECMO); Thromboelastography; Anticoagulation monitoring; aPTT; Anti-factor Xa; Point-of-care

Outcome Measures

Primary Outcomes (3)

• Correlation between TEG (R-time K-TEG) and aPTT

  0-10 days

• Correlation of TEG parameters with "classical" coagulation tests

  0-10 days

• Ability of TEG data to identify patients at higher risk of bleeding (or clotting) during the course of ECMO

  0-10 days

Interventions

Thromboelastography DIAGNOSTIC_TEST

Thromboelastography (TEG 6s, global hemostasis cartridge) will be performed before ECMO insertion and at different time-points during the course of ECMO. In parallel a full coagulation work-up (aPTT, prothrombin time \[PT\], anti-Xa, activated clotting time\[ACT\], platelets count, d-dimers, von Willebrand panel and fibrinogen) will be measured simultaneously with each TEG.

Eligibility Criteria

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

Study Population

Adult patients suffering from cardiorespiratory failure and needing Extracorporeal Membrane Oxygenation

You may qualify if:

• Consecutive patients admitted in Toronto General Hospital Medical Surgical ICU (MSICU) supported with ECMO. Patients cannulated before admission (ECMO retrieval) can also be included

You may not qualify if:

• Refusal of consent, unavailability or impossibility to process blood samples before ECMO cannulation

Sponsors & Collaborators

• Damian Ratano: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2N2, Canada

Location

Related Publications (15)

• Sauer CM, Yuh DD, Bonde P. Extracorporeal membrane oxygenation use has increased by 433% in adults in the United States from 2006 to 2011. ASAIO J. 2015 Jan-Feb;61(1):31-6. doi: 10.1097/MAT.0000000000000160.

  PMID: 25303799 BACKGROUND

• Gorbet MB, Sefton MV. Biomaterial-associated thrombosis: roles of coagulation factors, complement, platelets and leukocytes. Biomaterials. 2004 Nov;25(26):5681-703. doi: 10.1016/j.biomaterials.2004.01.023.

  PMID: 15147815 BACKGROUND

• Annich GM. Extracorporeal life support: the precarious balance of hemostasis. J Thromb Haemost. 2015 Jun;13 Suppl 1:S336-42. doi: 10.1111/jth.12963.

  PMID: 26149045 BACKGROUND

• Zangrillo A, Landoni G, Biondi-Zoccai G, Greco M, Greco T, Frati G, Patroniti N, Antonelli M, Pesenti A, Pappalardo F. A meta-analysis of complications and mortality of extracorporeal membrane oxygenation. Crit Care Resusc. 2013 Sep;15(3):172-8.

  PMID: 23944202 BACKGROUND

• Garcia DA, Baglin TP, Weitz JI, Samama MM. Parenteral anticoagulants: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e24S-e43S. doi: 10.1378/chest.11-2291.

  PMID: 22315264 BACKGROUND

• Kreyer S, Muders T, Theuerkauf N, Spitzhuttl J, Schellhaas T, Schewe JC, Guenther U, Wrigge H, Putensen C. Hemorrhage under veno-venous extracorporeal membrane oxygenation in acute respiratory distress syndrome patients: a retrospective data analysis. J Thorac Dis. 2017 Dec;9(12):5017-5029. doi: 10.21037/jtd.2017.11.05.

  PMID: 29312706 BACKGROUND

• Ratano D, Alberio L, Delodder F, Faouzi M, Berger MM. Agreement between activated partial thromboplastin time and anti-Xa activity in critically ill patients receiving therapeutic unfractionated heparin. Thromb Res. 2019 Mar;175:53-58. doi: 10.1016/j.thromres.2019.01.002. Epub 2019 Jan 7.

  PMID: 30708169 BACKGROUND

• Basu D, Gallus A, Hirsh J, Cade J. A prospective study of the value of monitoring heparin treatment with the activated partial thromboplastin time. N Engl J Med. 1972 Aug 17;287(7):324-7. doi: 10.1056/NEJM197208172870703. No abstract available.

  PMID: 5041701 BACKGROUND

• Levine MN, Hirsh J, Gent M, Turpie AG, Cruickshank M, Weitz J, Anderson D, Johnson M. A randomized trial comparing activated thromboplastin time with heparin assay in patients with acute venous thromboembolism requiring large daily doses of heparin. Arch Intern Med. 1994 Jan 10;154(1):49-56.

  PMID: 8267489 BACKGROUND

• Atallah S, Liebl M, Fitousis K, Bostan F, Masud F. Evaluation of the activated clotting time and activated partial thromboplastin time for the monitoring of heparin in adult extracorporeal membrane oxygenation patients. Perfusion. 2014 Sep;29(5):456-61. doi: 10.1177/0267659114524264. Epub 2014 Feb 25.

  PMID: 24570077 BACKGROUND

• Panigada M, E Iapichino G, Brioni M, Panarello G, Protti A, Grasselli G, Occhipinti G, Novembrino C, Consonni D, Arcadipane A, Gattinoni L, Pesenti A. Thromboelastography-based anticoagulation management during extracorporeal membrane oxygenation: a safety and feasibility pilot study. Ann Intensive Care. 2018 Jan 16;8(1):7. doi: 10.1186/s13613-017-0352-8.

  PMID: 29340875 BACKGROUND

• Henderson N, Sullivan JE, Myers J, Wells T, Calhoun A, Berkenbosch J, Tzanetos DT. Use of Thromboelastography to Predict Thrombotic Complications in Pediatric and Neonatal Extracorporeal Membranous Oxygenation. J Extra Corpor Technol. 2018 Sep;50(3):149-154.

  PMID: 30250340 BACKGROUND

• Riley JB, Schears GJ, Nuttall GA, Oliver WC Jr, Ereth MH, Dearani JA. Coagulation Parameter Thresholds Associated with Non-Bleeding in the Eighth Hour of Adult Cardiac Surgical Post-Cardiotomy Extracorporeal Membrane Oxygenation. J Extra Corpor Technol. 2016 Jun;48(2):71-8.

  PMID: 27578897 BACKGROUND

• Gurbel PA, Bliden KP, Tantry US, Monroe AL, Muresan AA, Brunner NE, Lopez-Espina CG, Delmenico PR, Cohen E, Raviv G, Haugen DL, Ereth MH. First report of the point-of-care TEG: A technical validation study of the TEG-6S system. Platelets. 2016 Nov;27(7):642-649. doi: 10.3109/09537104.2016.1153617. Epub 2016 Apr 11.

  PMID: 27809712 BACKGROUND

• Delmas C, Jacquemin A, Vardon-Bounes F, Georges B, Guerrero F, Hernandez N, Marcheix B, Seguin T, Minville V, Conil JM, Silva S. Anticoagulation Monitoring Under ECMO Support: A Comparative Study Between the Activated Coagulation Time and the Anti-Xa Activity Assay. J Intensive Care Med. 2020 Jul;35(7):679-686. doi: 10.1177/0885066618776937. Epub 2018 May 16.

  PMID: 29768983 BACKGROUND

Related Links

• Extracorporeal life support organisation (ELSO) anticoagulation guidelines
• TEG 6s description

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Damian Ratano, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Eddy Fan, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: June 3, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)