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Diagnostic Accuracy Study of a Point-of-Care Test for Coagulation Function

NCT06037720 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-09-14

No results posted yet for this study

Summary

Intraoperative coagulopathies in complex procedures are common. For the diagnosis and adequate therapy, laboratory tests are necessary, which can delay the patient's therapy. In this sense, the study aims to evaluate the point-of-care test device for patients undergoing surgeries with cardiopulmonary bypass.

Objective: To analyze the accuracy between the point-of-care diagnostic method and the laboratory test considered the gold standard for checking the INR.

Methodology: Cross-sectional study of diagnostic accuracy with simultaneous testing of the Coaguchek XS device and standard laboratory method in patients undergoing cardiopulmonary bypass to evaluate INR results.

Conditions

  • CoaguChek® XS System
  • Coagulation Function

Interventions

DEVICE

Coaguchek testing

Patients scheduled electively to undergo cardiac surgery with cardiopulmonary bypass at Hospital de Base in the Federal District.

Sponsors & Collaborators

  • Hospital de Base

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-01-31
Completion
2024-01-31

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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 NCT06037720 on ClinicalTrials.gov