CompletedNot Applicable

Thrombo-Elastography Guided Management of ECMO

Canada61 participantsStarted 2020-06-03

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consecutive patients admitted in Toronto General Hospital Medical Surgical ICU (MSICU) supported with ECMO. Patients cannulated before admission (ECMO retrieval) can also be included Exclusion Criteria: * Refusal of consent, unavailability or impossibility to process blood samples before ECMO cannulation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 0-10 days

Correlation of TEG parameters with "classical" coagulation tests

Timeframe: 0-10 days

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

Timeframe: 0-10 days

Trial details

NCT IDNCT04268940

SponsorDamian Ratano

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-04

View on ClinicalTrials.gov More Extracorporeal Circulation of Blood; Thrombocytopenia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.