UnknownNot Applicable

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

50 participantsStarted 2023-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients over 18 years old * admitted to the Hospital de Base of the Federal District for cardiac surgery, who volunteered to participate in the examination both by the traditional method of venous INR examination and by the use of the Coaguchek device and only after signing the TCLE. Exclusion Criteria: * patients who give up the research even after signing the TCLE will be excluded * patients who do not meet the aforementioned inclusion criteria * patients who refuse to participate in the study * patients with kidney, liver, hematological disease or any disease that affects coagulation * patients participating in other studies

What they're measuring

Point-of-care diagnostic method

Timeframe: During surgery

Trial details

NCT IDNCT06037720

SponsorHospital de Base

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01

Contact for this trial

Nadja Gloria C Graça, MD

556133151588 nadjagcg@hotmail.com