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

NCT06037720 | Unknown

• 1 other identifier: PeriopCoaguChek
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

CoaguChek® XS System; International normalized ratio; Point-of-care testing; Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Point-of-care diagnostic method

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

  During surgery

Interventions

Coaguchek testing DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• patients who give up the research even after signing the TCLE will be excluded
• 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

Sponsors & Collaborators

• Hospital de Base: lead

Related Publications (2)

• Khalaf-Adeli E, Alavi M, Alizadeh-Ghavidel A, Pourfathollah AA. Comparison of standard coagulation testing with thromboelastometry tests in cardiac surgery. J Cardiovasc Thorac Res. 2019;11(4):300-304. doi: 10.15171/jcvtr.2019.48. Epub 2019 Oct 13.

  PMID: 31824611 BACKGROUND

• Mendonca FT, Matos SH, Moreira LG, Pereira IL, Dino LL, Braga MB, Dias GHDS. Accuracy of a point-of-care CoaguChek test versus standard laboratory coagulation monitoring in cardiac surgery involving cardiopulmonary bypass: randomized clinical trial. Braz J Anesthesiol. 2025 Nov 22;76(2):844714. doi: 10.1016/j.bjane.2025.844714. Online ahead of print.

  PMID: 41276168 DERIVED

Central Study Contacts

Nadja Gloria C Graça, MD

CONTACT

556133151588; nadjagcg@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, PhD

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09