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

Atrial Fibrillation Clinical Trial

Official title:

Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140631
• Other study ID #: HUM00117851
• Status: Completed
• Phase: Phase 4
• Start date: March 23, 2017
• Est. completion date: April 3, 2018

Study information

• Verified date: September 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: April 3, 2018
• Est. primary completion date: November 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation

Intervention

Drug:
• Protamine Sulfate
Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.

Locations

Country	Name	City	State
United States	Michigan Medicine	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Ambulation	Total length of time from procedural termination to patient ambulation	0 to 24 hours
Secondary	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)	checked at 30 and 90 days