- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04285840
Arterial Versus Venous Activated Clotting Time (ACT) Measurements During Atrial Fibrillation Ablations
Arterial Versus Venous Activated Clotting Time Measurements During Atrial Fibrillation Ablations
Study Overview
Detailed Description
This project aims to establish a standardized procedure for venous ACT sampling during atrial fibrillation ablation in 50 adults. Analyses will examine the relationship and agreement between venous and arterial ACTs. It is anticipated that the standardized procedure could eliminate the need for an arterial line for ACT measurement which would reduce patient risks for bleeding, infection, and discomfort.
Patients who are scheduled for for atrial fibrillation ablations will be invited to participate in this project. An information sheet will be provided about the project to potential participants. If the potential participant expresses interest, a study specific consent consent will be obtained to allow the additional paired blood samples to be drawn throughout the procedure. The additional blood volume to be drawn is expected to be less than or equal to a teaspoon of venous blood. Participation will be completely voluntary.
Patients will undergo usual standard of care for the procedure, including usual arterial and venous sheath/catheter insertions. After obtaining venous and arterial access, baseline ACTs will be drawn using the outlined ACT sampling procedure. The ACT value for both arterial and venous samples will be obtained using the standard procedure for Hemochron Signature Elite point-of-care testing; this test uses less than 0.5 cc blood. ACT samples will be performed at baseline (pre-heparin administration), every 30 minutes during the procedure (per standard ACT monitoring protocol to obtain and maintain desired ACT), and at the end of procedure prior to arterial and venous sheath removal. Time of procedure ranges from 2 to 4 hours and may result in a minimum of 2 paired samples (pre and end) to a maximum of 9 paired samples (pre, end, and every 30 minutes) per patient; this equates to an additional 1 cc to 4.5 cc of additional blood for paired sampling per patient.
ACT arterial and venous sampling procedure: Using a stopcock at the nearest point of insertion, withdraw 30 cc of blood in a syringe; turn the stopcock and remove 0.5cc of blood for ACT testing; turn the stopcock to return the 30 cc blood and flush the line; remove the syringe with the ACT sample and flush the line with saline, replace syringes for the next ACT sampling process.
Patients undergoing atrial fibrillation ablations will continue to have Heparin dosed on the arterial ACT sample results only per the standard of care. Heparin will not be administered based on venous ACT levels obtained during this project. The purpose for paired sampling is to verify that the proposed venous sampling method is accurate and provides an evaluable sample to compare with the ACT sample results.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Raleigh, North Carolina, United States, 27609
- Duke Health Raleigh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Adult scheduled for routine atrial ablation procedure
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single arm study
To establish a standardized procedure for venous ACT sampling during atrial fibrillation ablation.
Analyses will examine the relationship and agreement between venous and arterial ACTs.
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Matched/paired venous ACT samples will be drawn at the same time as arterial ACT samples to compare the results agreement between venous and arterial ACTs.
Subjects undergoing atrial fibrillation ablations will continue to have Heparin dosed on the arterial ACT sample results only per the standard of care.
Heparin will not be administered based on venous ACT levels obtained during this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of venous ACT samples that match arterial ACT sample results during atrial fibrillation ablation
Time Frame: Day of atrial fibrillation ablation procedure
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Paired samples pre and during the ablation procedure
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Day of atrial fibrillation ablation procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Allen Deborah, PhD, Duke Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00104539
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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