Clinical Evaluation of the Hemosonics Quantra® Coagulation Monitor in Liver and Multivisceral Transplantation

NCT04274699 | Withdrawn FDA Device

• 1 other identifier: A095196 IRAS_ID_256865
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Severe coagulopathy and operative bleeding are common in liver and multivisceral transplant recipients. This is related to reduced synthesis and function of clotting proteins in end-stage liver disease, thrombocytopaenia, thrombocytopathy, accelerated fibrinolysis, portal hypertension, inflammatory adhesions and intraoperative hemodilution. A pro-coagulant state is also a common finding in both groups, sometimes associated with fatal thromboembolism, and the balance between anti- and pro-coagulant effects is easily disrupted by intraoperative events. Use of point-of-care intraoperative viscoelastic testing, capable of discriminating between various potential causes of coagulopathy and of identifying some hypercoagulable states, is now routine in this setting. This has been shown to guide treatment faster and more reliably than standard laboratory screening tests. However, traditional viscoelastic tests based on a pin-and-cup arrangement are sensitive to technical error, movement and physical clot disruption, and the validity of measurements is highly dependent on operator training. A newer method (TEG® 6S) based on light reflection from a blood meniscus reduces scope for operator error but remains sensitive to movement. Measurement of ultrasonic resonance (or 'sonic estimation of elasticity via resonance \[SEER\] sonorheometry') using the Quantra® analyzer surgery appears to minimize these problems in studies performed in healthy volunteers, in spinal surgery and in both elective and urgent cardiac procedures. Pilot testing in the latter group suggests it may also differentiate qualitatively between fibrinogen and platelet deficiency, but the range of intrinsic coagulation disturbances in this context is limited. This study proposes to assess the validity of the Quantra® analyzer in a population with more extreme coagulopathy, including severe fibrinolysis, and recognized thrombophilic states.

Conditions

Coagulopathy; Liver Transplantation

Keywords

Liver Transplantation; Thromboelastography; Coagulopathy

Outcome Measures

Primary Outcomes (1)

• Quantra® parameters' correlation with conventional laboratory tests (including thrombin generation), TEG® 6S parameters and clinical bleeding scores.

  Quantra® parameters: CT (clot time, intrinsic pathway) CS (clot stiffness) FCS (fibrinogen contribution to clot stiffness) PCS (platelet contribution to clot stiffness) Fibrinolysis Index TEG® 6S parameters: TEG-ACT (activated clotting time) R-time (reaction time) K-time (coagulation time) Alpha angle (clot formation) Maximum Amplitude (clot strength) LY30 (clot lysis % at 30 minutes) FLEV / Functional Fibrinogen (fibrinogen concentration) +/- Endogenous Thrombin Potential (thrombin generation) Surgeon's visual rating of clinical coagulopathy (Trans-Agency Consortium for Trauma Induced Coagulopathy (TACTIC) scoring system, adapted for liver transplantation): 0 (exceptionally dry surgical field) to 5 (very oozy with no visible clot); +/- perceived 'surgical' element: none, partial, mostly surgical), to be performed at times of routine sampling.

  1 year

Interventions

Hemosonics Quantra coagulation monitor DIAGNOSTIC_TEST

There is no categorisation or allocation of any subject to any intervention vs non-intervention group. Blood sampling and the addition of a Quantra coagulation test is the only 'intervention', and the sampling protocol is identical for all subjects. Post-testing treatment of all subjects is as per established routine and Quantra results will not be used by clinical team.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult liver and multi visceral transplant recipients

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• HemoSonics LLC: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Citrated blood for thrombin generation assay

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• John R Klinck, FRCPC

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist, Principal Investigator

Study Record Dates

• First Submitted: February 15, 2020
• First Posted: February 18, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 20, 2023

Record last verified: 2020-02