Thrombin Generation in Liver Transplant Surgery

NCT04762550 | Unknown

• 1 other identifier: 20-5414.0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Thrombin Generation - Endogenous Thrombin Potential (nM*min)

  The change in thrombin generation will be measured in patients undergoing liver transplantation, as assessed through the Endogenous Thrombin Potential (nM\*min)

  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)

  The change in thrombin generation will be measured in patients undergoing liver transplantation as assessed by the Lag Time (Seconds)

  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)

  The change in thrombin generation will be measured in patients undergoing liver transplantation by the Time to Peak (Seconds)

  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)

  The change in thrombin generation will be measured in patients undergoing liver transplantation by the Peak Height (nM)

  The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively

Secondary Outcomes (5)

• Conventional Hemostatic Tests - Platelet Count

  The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively

• Conventional Hemostatic Tests - INR

  The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively

• Conventional Hemostatic Tests - aPTT

  The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively

• Conventional Hemostatic Tests - Fibrinogen Level

  The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively

• Viscoelastic Testing

  The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively

Other Outcomes (7)

• Transfusion Outcomes - Red Blood Cells

  From intra-operatively to within 12 hours post-operatively

• Transfusion Outcomes - Platelets

  From intra-operatively to within 12 hours post-operatively

• Transfusion Outcomes - Frozen Plasma

  From intra-operatively to within 12 hours post-operatively

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consenting adults undergoing liver transplantation surgery at Toronto General Hospital

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital - University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and plasma specimens in citrated tubes

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Justyna Bartoszko, MD MSc FRCPC

  Toronto General Hospital - University Health Network

  PRINCIPAL INVESTIGATOR

• Keyvan Karkouti, MD MSc FRCPC

  Toronto General Hospital - University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justyna Bartoszko, MD MSc FRCPC

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 21, 2021
• Study Start: March 8, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)