Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05426564
Other study ID # HEMCS-041
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 27, 2022
Est. completion date June 1, 2023

Study information

Verified date June 2023
Source HemoSonics LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective, observational exploratory study of the performance of the Quantra System in adult patients that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure.


Description:

Patients 18 years or older that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure will be enrolled in this prospective, observational exploratory study. From each enrolled subject, blood samples will be collected at multiple time points for analysis on the Quantra QPlus or QStat Cartridge in parallel with other assessments performed as standard of care.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 1, 2023
Est. primary completion date May 17, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject is > 18 years. - Subject is scheduled to undergo either VA or VV ECMO procedure or has been placed on VA or VV ECMO within 24 hours. - Subject or subject's legally authorized representative (LAR) is willing to provide informed consent, either prospectively or by deferred consent. Exclusion Criteria: - Subject is younger than 18 years of age. - Subject is pregnant. - Subject is incarcerated at the time of the study. - Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent. - Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Locations

Country Name City State
United States University of California Irvine Irvine California

Sponsors (2)

Lead Sponsor Collaborator
HemoSonics LLC University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of Quantra Clot Time results to standard coagulation test results. Coagulation function assessed by Quantra and standard-of-care coagulation tests At the start of ECMO (considered the Baseline timepoint)
Primary Comparison of Quantra Clot Stiffness results to standard coagulation test results. Coagulation function assessed by Quantra and standard-of-care coagulation tests At the start of ECMO (considered the Baseline timepoint)
Primary Comparison of Quantra Clot Time results to standard coagulation test results. Coagulation function assessed by Quantra and standard-of-care coagulation tests 6 hours after the previous measurment
Primary Comparison of Quantra Clot Stiffness results to standard coagulation test results. Coagulation function assessed by Quantra and standard-of-care coagulation tests 6 hours after the previous measurment
See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Recruiting NCT04398628 - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Not yet recruiting NCT05830916 - Diagnostic Role of Antiphospholipid Antibodies and Microparticles in Immune Thrombocytopenic Patients With Thrombosis
Recruiting NCT02972385 - Pharmacogenomics of Warfarin in Hispanics and Latinos
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02526628 - Thrombosis and Neurocognition in Klinefelter Syndrome
Completed NCT02439190 - CV004-007 Thrombosis Chamber Study Phase 1
Completed NCT02341638 - Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects Phase 1
Completed NCT01855516 - Partial Thromboplastin Time After 72 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin N/A
Unknown status NCT00983112 - Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery Phase 4
Completed NCT00412464 - Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis Phase 1
Completed NCT00479362 - Anticoagulant Therapy During Pacemaker Implantation Phase 4
Completed NCT00346424 - Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters Phase 3
Terminated NCT00303420 - Alteplase for Blood Flow Restoration in Hemodialysis Catheters Phase 4
Completed NCT00143715 - Oral Vitamin K for Warfarin Associated Coagulopathy Phase 3
Completed NCT00039858 - Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin Phase 4
Completed NCT00007410 - Genetic Architecture of Plasma T-PA and PAI-1 N/A
Completed NCT00000538 - Dietary Effects on Lipoproteins and Thrombogenic Activity Phase 3
Completed NCT00005436 - Lupus Cohort--Thrombotic Events and Coronary Artery Disease N/A
Completed NCT00000466 - Postmenopausal Estrogen/Progestin Interventions (PEPI) Phase 3