Recruiting

Thrombin

Sponsor:

University Health Network, Toronto

Code:

NCT04762576

Conditions

Thrombin

Hemostatic Disorder

Surgical Blood Loss

Coagulation Disorder

Cardiovascular Surgical Procedures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Coagulopathy, bleeding, and transfusion are common in cardiac surgical patients. Our collaborator has developed a novel point of care device that can be used to assess thrombin generation in real-time in cardiac surgical patients. The investigators will measure thrombin generation using our novel device and compare it to standard methods, while examining the association of thrombin parameters with bleeding and other clinical outcomes.

Conditions

Thrombin

Hemostatic Disorder

Surgical Blood Loss

Coagulation Disorder

Cardiovascular Surgical Procedures

Study ID

NCT04762576

Start date

Aug 10, 2022

Status verified date

Nov, 2022

Completion date

Jan 1, 2023

Anticipated

Primary completion date

Jan 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

-All adult patients (> 18 years of age) undergoing cardiac surgery at Toronto General Hospital will be offered participation.

Exclusion Criteria:

-Patients who are unable to consent to the study or who refuse participation will be excluded.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Cardiac Surgical Patients

All consenting adults undergoing cardiac surgery at Toronto General Hospital.

Primary outcome measure

  • Thrombin Generation, as assessed by the Endogenous Thrombin Potential (ETP) [ Time Frame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively ]
  • Thrombin Generation, as assessed by the Lag Time [ Time Frame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively ]
  • Thrombin Generation, as assessed by the Time to Peak [ Time Frame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively ]
  • Thrombin Generation, as assessed by the Peak Height [ Time Frame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively ]

Central Contacts and Locations

Central contacts

Justyna Bartoszko, MD MSc FRCPC

416-340-4800justyna.bartoszko@uhn.ca

Locations

Toronto General Hospital - University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Justyna Bartoszko, MD MSc FRCPC

416-340-4800justyna.bartoszko@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 9, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2022-11-09.