Extracorporeal Circulation of Blood; ThrombocytopeniaTEGMONCT04268940
Thrombo-Elastography Guided Management of ECMO
An observational study of Extracorporeal Circulation of Blood; Thrombocytopenia, run by Damian Ratano at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Circulation of Blood; Thrombocytopenia
- What is being tested?
- Thromboelastography
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jun 2020to 4 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult patients suffering from cardiorespiratory failure and needing Extracorporeal Membrane Oxygenation
Who may be able to join
- Consecutive patients admitted in Toronto General Hospital Medical Surgical ICU (MSICU) supported with ECMO. Patients cannulated before admission (ECMO retrieval) can also be included
Who cannot join
- Refusal of consent, unavailability or impossibility to process blood samples before ECMO cannulation
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
ECMO induces both a risk of clotting and bleeding. Therapeutic anticoagulation is recommended during ECMO. While preventing clotting, anticoagulation triggers a higher risk of bleeding. However, anticoagulation does not completely avoid clotting due to complex interactions between the circuit, the patients' blood and the anticoagulant. Unfractionated heparin (UFH) is the most commonly used anticoagulant and requires monitoring. No clear recommendation exists. The activated partial thromboplastin time (aPTT) as well as the anti-factor Xa activity (anti-Xa) are plasma-based tests used to monitor UFH. The evidence for their use is poor and they do no correlate well. Moreover, these two tests do not take into account all the elements of blood and do not reflect the entire coagulation process.
Thromboelastography is a whole-blood point-of-care test that describes each phases of the clotting process from the activation of coagulation factors to the later lysis to the thrombus. TEG is also sensitive to UFH and can be used to quantify its effect. The use of heparinase during TEG also permits to evaluate the coagulation process during the use of heparin. This could give an important understanding of the effect of the ECMO itself on the circuit and help to develop a strategy to prevent bleeding and clotting as well as monitor heparin treatment.
The hypothesis for this study is that the use of thromboelastography will identify situations with high risk of bleeding and allow interventions to reduce hemorrhagic events and blood products transfusions. It is also hypothesized that the monitoring of unfractionated heparin (UFH) with TEG is feasible and could lead to the use of less UFH during the course of ECMO.
The objectives of this study are 1) to determine and calibrate the TEG R-time values corresponding to aPTT therapeutic range for patients under therapeutic UFH during ECMO course, 2) to determine the level of correlation of TEG parameters with other anticoagulation tests [Prothrombin Time (PT), anti-Xa, activated clotting time (ACT)], fibrinogen level, platelets count and d-dimers, 3) to determine the TEG values that are associated with the administration of blood-derived coagulation products in clinical practice 4) to identify TEG cutoff points that are associated with an increased risk of bleeding/clotting in ECMO patients 5) use these observational data to develop a TEG-based algorithm for anticoagulation management and blood products replacement that could be tested in a future study.
This study will you the last version of TEG, TEG-6s which is a fully automated point-of-care device.
- Being tested
- Thromboelastography
- Keywords
- Unfractionated heparin, Extracorporeal Membrane Oxygenation (ECMO), Thromboelastography, Anticoagulation monitoring, aPTT, Anti-factor Xa, Point-of-care
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastographyDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between TEG (R-time K-TEG) and aPTT
Measured: 0-10 days
Correlation of TEG parameters with "classical" coagulation tests
Measured: 0-10 days
Ability of TEG data to identify patients at higher risk of bleeding (or clotting) during the course of ECMO
Measured: 0-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start3 Jun 2020
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Circulation of Blood; ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damian Ratano
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor-investigator, Damian Ratano, University Health Network, Toronto
- Investigators
- Damian Ratano, MD, Principal investigator, University Health Network, TorontoEddy Fan, MD, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268940
- Sponsor's protocol ID
- 19-5121
- Acronym
- TEGMO
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2020
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25303799Gorbet 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.
PubMed 15147815Annich GM. Extracorporeal life support: the precarious balance of hemostasis. J Thromb Haemost. 2015 Jun;13 Suppl 1:S336-42. doi: 10.1111/jth.12963.
PubMed 26149045Zangrillo 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.
PubMed 23944202Garcia 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.
PubMed 22315264Kreyer 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.
PubMed 29312706Ratano 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.
PubMed 30708169Basu 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.
PubMed 5041701Levine 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.
PubMed 8267489Atallah 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.
PubMed 24570077Panigada 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.
PubMed 29340875Henderson 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.
PubMed 30250340Riley 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.
PubMed 27578897Gurbel 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.
PubMed 27809712Delmas 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.
PubMed 29768983
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombo-Elastography Guided Management of ECMO
- ClinicalTrials.gov ID
- NCT04268940
- Acronym / sponsor ID
- TEGMO / 19-5121
- Keywords
- Unfractionated heparin, Extracorporeal Membrane Oxygenation (ECMO), Thromboelastography, Anticoagulation monitoring, aPTT, Anti-factor Xa, Point-of-care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Damian RatanoUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
ECMO induces both a risk of clotting and bleeding. Therapeutic anticoagulation is recommended during ECMO. While preventing clotting, anticoagulation triggers a higher risk of bleeding. However, anticoagulation does not completely avoid clotting due to complex interactions between the circuit, the patients' blood and the anticoagulant. Unfractionated heparin (UFH) is the most commonly used anticoagulant and requires monitoring. No clear recommendation exists. The activated partial thromboplastin time (aPTT) as well as the anti-factor Xa activity (anti-Xa) are plasma-based tests used to monitor UFH. The evidence for their use is poor and they do no correlate well. Moreover, these two tests do not take into account all the elements of blood and do not reflect the entire coagulation process.
Thromboelastography is a whole-blood point-of-care test that describes each phases of the clotting process from the activation of coagulation factors to the later lysis to the thrombus. TEG is also sensitive to UFH and can be used to quantify its effect. The use of heparinase during TEG also permits to evaluate the coagulation process during the use of heparin. This could give an important understanding of the effect of the ECMO itself on the circuit and help to develop a strategy to prevent bleeding and clotting as well as monitor heparin treatment.
The hypothesis for this study is that the use of thromboelastography will identify situations with high risk of bleeding and allow interventions to reduce hemorrhagic events and blood products transfusions. It is also hypothesized that the monitoring of unfractionated heparin (UFH) with TEG is feasible and could lead to the use of less UFH during the course of ECMO.
The objectives of this study are 1) to determine and calibrate the TEG R-time values corresponding to aPTT therapeutic range for patients under therapeutic UFH during ECMO course, 2) to determine the level of correlation of TEG parameters with other anticoagulation tests [Prothrombin Time (PT), anti-Xa, activated clotting time (ACT)], fibrinogen level, platelets count and d-dimers, 3) to determine the TEG values that are associated with the administration of blood-derived coagulation products in clinical practice 4) to identify TEG cutoff points that are associated with an increased risk of bleeding/clotting in ECMO patients 5) use these observational data to develop a TEG-based algorithm for anticoagulation management and blood products replacement that could be tested in a future study.
This study will you the last version of TEG, TEG-6s which is a fully automated point-of-care device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suffering from cardiorespiratory failure and needing Extracorporeal Membrane Oxygenation
Key inclusion criteria (1 listed)
- Consecutive patients admitted in Toronto General Hospital Medical Surgical ICU (MSICU) supported with ECMO. Patients cannulated before admission (ECMO retrieval) can also be included
Key exclusion criteria (1 listed)
- Refusal of consent, unavailability or impossibility to process blood samples before ECMO cannulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThromboelastographyThromboelastography (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. | Diagnostic test | – |
Primary outcome
Correlation between TEG (R-time K-TEG) and aPTT
Time frame: 0-10 days
Correlation of TEG parameters with "classical" coagulation tests
Time frame: 0-10 days
Ability of TEG data to identify patients at higher risk of bleeding (or clotting) during the course of ECMO
Time frame: 0-10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 25303799Sauer 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.
- Background: PubMed 15147815Gorbet 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.
- Background: PubMed 26149045Annich GM. Extracorporeal life support: the precarious balance of hemostasis. J Thromb Haemost. 2015 Jun;13 Suppl 1:S336-42. doi: 10.1111/jth.12963.
- Background: PubMed 23944202Zangrillo 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.
- Background: PubMed 22315264Garcia 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.
- Background: PubMed 29312706Kreyer 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.
- Background: PubMed 30708169Ratano 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.
- Background: PubMed 5041701Basu 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.
- Background: PubMed 8267489Levine 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.
- Background: PubMed 24570077Atallah 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.
- Background: PubMed 29340875Panigada 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.
- Background: PubMed 30250340Henderson 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.
- Extracorporeal life support organisation (ELSO) anticoagulation guidelinesLink provided by the sponsor.
- TEG 6s descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damian Ratano, MD principal investigator
University Health Network, Toronto
Eddy Fan, MD, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Circulation of Blood; Thrombocytopenia, run by Damian Ratano at 1 site in Canada.
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: finished, as of the sponsor's last update on 16 Jan 2026. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between TEG (R-time K-TEG) and aPTT (time frame: 0-10 days). The study lists 3 primary outcomes in all. 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 NCT04268940, which also lists 15 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 16 Jan 2026.