Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT03140631|
Recruitment Status : Completed
First Posted : May 4, 2017
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Catheter Ablation||Drug: Protamine Sulfate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||153 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation: A Randomized Trial|
|Actual Study Start Date :||March 23, 2017|
|Actual Primary Completion Date :||November 16, 2017|
|Actual Study Completion Date :||April 3, 2018|
No Intervention: 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.
Active Comparator: 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.
Drug: Protamine Sulfate
Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.
- Time to Ambulation [ Time Frame: 0 to 24 hours ]Total length of time from procedural termination to patient ambulation
- Count of Participants Who Experienced Vascular Access Site Complications [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140631
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Hakan Oral, MD||University of Michigan|