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

NCT ID: NCT03140631

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-23
• Study Completion Date: 2018-04-03

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.

Conditions

Atrial Fibrillation; Catheter Ablation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Protamine Sulfate

Intervention Type: DRUG

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

Interventions

Protamine Sulfate

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Hakan Oral

Director, Cardiac Arrhythmia Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hakan Oral, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Michigan Medicine

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00117851

Identifier Type: -

Identifier Source: org_study_id