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

NCT04274699 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-07-20

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Hemosonics Quantra coagulation monitor

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.

Sponsors & Collaborators

  • HemoSonics LLC

    collaborator INDUSTRY

  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • John R Klinck, FRCPC · Cambridge University Hospitals NHS Foundation Trust

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2021-10-31
Completion
2021-10-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04274699 on ClinicalTrials.gov