A Novel Point-to-care Method for Fast Evaluation of Viscoelastic Hemostasis Analysis

NCT05921799 | Unknown

• 1 other identifier: 2022-0951
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the results of the existing coagulation monitoring technology to the Ultrasound-based viscoelastic hemostasis analysis, a new method, using small amount of extra blood obtained during routine blood draws in surgery patients.

Conditions

Perioperative Period

Keywords

blood coagulation; blood coagulation tests

Outcome Measures

Primary Outcomes (2)

• Comparison of the novel viscoelastic hemostasis analysis results to TEG results

  Coagulation function assessed by the novel viscoelastic hemostasis analysis and TEG

  1 day

• Comparison of the novel viscoelastic hemostasis analysis results to standard coagulation test results

  Coagulation function assessed by the novel viscoelastic hemostasis analysis and standard coagulation test

  1 day

Study Arms (1)

General anesthesia Patients

Subjects experiencing general anesthesia such that viscoelastic testing is performed to assess coagulopathy.

Procedure: Blood specimen collection

Interventions

Blood specimen collection PROCEDURE

Routinely collect citrate blood and native blood from patients as required by their condition.

General anesthesia Patients

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

Participants for this study will be recruited at the Second Affiliated Hospital Zhejiang University School of Medicine. The study participants will be adult general anesthesia patients such that viscoelastic testing is performed to assess coagulopathy.

You may qualify if:

• Subject is scheduled for surgery with general surgery
• Subject is 18 years or order
• Subject requires routine TEG measurement

You may not qualify if:

• Subject is unwilling to participate
• Subject is unable to sign a consent form
• Subject is unsuitable for blood drawing
• Subject is unsuitable for this study in the opinion of the anesthesiologist

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: June 27, 2023
• Study Start: June 20, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 17, 2024

Record last verified: 2023-06

Locations

CN (1)