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

University of Michigan

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation; Catheter Ablation

Treatments: Drug: Protamine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT03140631

HUM00117851

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Control

No Intervention group

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.

Protamine

Active Comparator group

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.

Treatment:

Drug: Protamine Sulfate