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Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT03140631
Recruitment Status : Completed
First Posted : May 4, 2017
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hakan Oral, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Catheter Ablation Drug: Protamine Sulfate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation: A Randomized Trial
Actual Study Start Date : March 23, 2017
Actual Primary Completion Date : November 16, 2017
Actual Study Completion Date : April 3, 2018


Arm Intervention/treatment
No Intervention: Control
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.
Active Comparator: Protamine
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.
Drug: Protamine Sulfate
Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.




Primary Outcome Measures :
  1. Time to Ambulation [ Time Frame: 0 to 24 hours ]
    Total length of time from procedural termination to patient ambulation


Secondary Outcome Measures :
  1. Count of Participants Who Experienced Vascular Access Site Complications [ Time Frame: checked at 30 and 90 days ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140631


Locations
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United States, Michigan
Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Hakan Oral, MD University of Michigan
  Study Documents (Full-Text)

Documents provided by Hakan Oral, University of Michigan:

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Responsible Party: Hakan Oral, Director, Cardiac Arrhythmia Service, University of Michigan
ClinicalTrials.gov Identifier: NCT03140631     History of Changes
Other Study ID Numbers: HUM00117851
First Posted: May 4, 2017    Key Record Dates
Results First Posted: October 23, 2018
Last Update Posted: October 23, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Hakan Oral, University of Michigan:
atrial fibrillation
catheter ablation
protamine sulfate
anticoagulation reversal
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heparin
Calcium heparin
Protamines
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Heparin Antagonists
Coagulants