Back to resultsUse of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation
Primary Purpose
Atrial Fibrillation, Catheter Ablation
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Protamine Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter ablation, protamine sulfate, anticoagulation reversal
Eligibility Criteria
Inclusion Criteria:
- Patient's referred for radiofrequency ablation (RFA) or cryoablation for atrial fibrillation or atrial flutter (left atrial).
- Age ≥ 18 year
- Patients who are mentally and linguistically able to understand the aim of the trial, comply with the trial protocol, verbally acknowledge the risks, benefits, and alternatives in this trial.
Exclusion Criteria:
- Previous intolerance or allergy to heparin products.
- Current or prior administration of protamine products
- History of femoral access site complications including hematoma, AV fistula, pseudoaneurysm, aneurysm.
- Known lower extremity venous thrombosis.
- Coagulopathy or blood dyscrasias.
- Active malignancy.
- Thrombocytosis (platelet count >600k/ul) or thrombocytopenia (platelet count <100k/ul)
- Planned use of vascular closure device
Sites / Locations
- Michigan Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Protamine
Arm Description
Patients in the control arm will undergo routine post-procedure management prior to removal of vascular sheaths. This includes routine measurements of ACT beginning 90 min after the cessation of the procedure with a goal ACT of <200s or return to pre-procedural baseline prior to sheath removal.
Patients in the active comparator arm will receive protamine sulfate for rapid reversal of heparin prior to sheath removal. They will first receive a small test dose with close hemodynamic monitoring followed by therapeutic dose if no reaction occurs.ACT levels will then be monitored with a goal ACT of <200s or return to preprocedural baseline prior to removal of vascular sheaths.
Outcomes
Primary Outcome Measures
Time to Ambulation
Total length of time from procedural termination to patient ambulation
Secondary Outcome Measures
Count of Participants Who Experienced Vascular Access Site Complications
Secondary endpoints will include the number of patients who experience a 90-day occurrence of vascular access site complications defined as hematoma formation, aneurysm, pseudoaneurysm, arteriovenous fistula formation, access-site related major bleeding (defined as Bleeding Academic Research Consortium (BARC) type 3a or 5), or procedural intervention for access complications (surgical repair, thrombin injection, et cetera)
Full Information
NCT ID
NCT03140631
First Posted
April 3, 2017
Last Updated
September 28, 2018
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT03140631
Brief Title
Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation
Official Title
Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 23, 2017 (Actual)
Primary Completion Date
November 16, 2017 (Actual)
Study Completion Date
April 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety, efficacy and efficiency of rapid anticoagulation reversal with protamine sulfate versus routine activated clotting time (ACT) monitoring in patients undergoing catheter based ablation of atrial fibrillation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Catheter Ablation
Keywords
atrial fibrillation, catheter ablation, protamine sulfate, anticoagulation reversal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control arm will undergo routine post-procedure management prior to removal of vascular sheaths. This includes routine measurements of ACT beginning 90 min after the cessation of the procedure with a goal ACT of <200s or return to pre-procedural baseline prior to sheath removal.
Arm Title
Protamine
Arm Type
Active Comparator
Arm Description
Patients in the active comparator arm will receive protamine sulfate for rapid reversal of heparin prior to sheath removal. They will first receive a small test dose with close hemodynamic monitoring followed by therapeutic dose if no reaction occurs.ACT levels will then be monitored with a goal ACT of <200s or return to preprocedural baseline prior to removal of vascular sheaths.
Intervention Type
Drug
Intervention Name(s)
Protamine Sulfate
Intervention Description
Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.
Primary Outcome Measure Information:
Title
Time to Ambulation
Description
Total length of time from procedural termination to patient ambulation
Time Frame
0 to 24 hours
Secondary Outcome Measure Information:
Title
Count of Participants Who Experienced Vascular Access Site Complications
Description
Secondary endpoints will include the number of patients who experience a 90-day occurrence of vascular access site complications defined as hematoma formation, aneurysm, pseudoaneurysm, arteriovenous fistula formation, access-site related major bleeding (defined as Bleeding Academic Research Consortium (BARC) type 3a or 5), or procedural intervention for access complications (surgical repair, thrombin injection, et cetera)
Time Frame
checked at 30 and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient's referred for radiofrequency ablation (RFA) or cryoablation for atrial fibrillation or atrial flutter (left atrial).
Age ≥ 18 year
Patients who are mentally and linguistically able to understand the aim of the trial, comply with the trial protocol, verbally acknowledge the risks, benefits, and alternatives in this trial.
Exclusion Criteria:
Previous intolerance or allergy to heparin products.
Current or prior administration of protamine products
History of femoral access site complications including hematoma, AV fistula, pseudoaneurysm, aneurysm.
Known lower extremity venous thrombosis.
Coagulopathy or blood dyscrasias.
Active malignancy.
Thrombocytosis (platelet count >600k/ul) or thrombocytopenia (platelet count <100k/ul)
Planned use of vascular closure device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakan Oral, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation
We'll reach out to this number within 24 hrs