Recruiting

Thrombin Generation

Sponsor:

University Health Network, Toronto

Code:

NCT04762550

Conditions

Liver Transplantation

Thrombin

Hemostasis, Surgical

Blood Coagulation Disorder Due to Liver Disease

Blood Coagulation Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a prospective observational study of 100 patients undergoing liver transplantation at a single centre. Thrombin generation and kinetics will be assessed using a novel point-of-care device, and compared to conventional measures of hemostasis as well as viscoelastic tests to pinpoint specific coagulation deficits and identify potential therapeutic targets. The clinical course of patients will be followed for major bleeding and transfusion outcomes.

Conditions

Liver Transplantation

Thrombin

Hemostasis, Surgical

Blood Coagulation Disorder Due to Liver Disease

Blood Coagulation Disorders

Study ID

NCT04762550

Start date

Mar 8, 2021

Status verified date

Feb, 2021

Completion date

Jan 1, 2022

Anticipated

Primary completion date

Jan 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All adult patients (> 18 years of age) proceeding to imminent (within 24 hours) liver transplantation surgery at Toronto General Hospital will be offered participation.
  • Patients should have end stage liver disease necessitating transplantation. All etiologies of end stage liver disease will be accepted.

Exclusion Criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients undergoing Liver Transplantation

This is a prospective observational study that intends to offer participation to all patients undergoing liver transplantation at Toronto General Hospital. Parameters that will be measured include Thrombin generation, viscoelastic testing utilizing ROTEM, and conventional laboratory testing (INR, aPTT and Fibrinogen level) at five time points: (a) Prior to cross-clamp application; (b) within the first 30 minutes of venous cross clamp removal; (c) after 30 minutes of reperfusion; (d) On arrival in the intensive care unit (ICU) or post-anesthesia recovery unit; and (5) 12 hours post-operatively.

Primary outcome measure

  • Thrombin Generation - Endogenous Thrombin Potential (nM*min) [ Time Frame: The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively ]
  • Thrombin Generation - Lag Time (Seconds) [ Time Frame: The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively ]
  • Thrombin Generation - Time to Peak (Seconds) [ Time Frame: The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively ]
  • Thrombin Generation - Peak Height (nM) [ Time Frame: The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 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

416-340-3567justyna.bartoszko@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 3, 2021

Last verified

Feb, 2021

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 2021-05-03.