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

Phase 4

Completed

• Conditions: Atrial Fibrillation; Catheter Ablation
• Interventions: Drug: Protamine Sulfate

• Registration Number: NCT03140631
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-23
• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Primary Completion: 2017-11-16
• Study Completion: 2018-04-03
• Results First Submitted: 2018-08-25
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-28
• Last Update Submitted: 2018-09-28
• Results First Posted: 2018-10-23
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protamine	Protamine Sulfate	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.

Primary Outcome Measures

Name	Time	Method
Time to Ambulation	0 to 24 hours	Total length of time from procedural termination to patient ambulation

Secondary Outcome Measures

Name	Time	Method
Count of Participants Who Experienced Vascular Access Site Complications	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)

Trial Locations

Locations (1)

Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States