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

NCT03140631 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2018-10-23

Study results available
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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

Interventions

DRUG

Protamine Sulfate

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

Sponsors & Collaborators

Principal Investigators

  • Hakan Oral, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2017-11-16
Completion
2018-04-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03140631 on ClinicalTrials.gov