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Trial record 18 of 174 for:    "Heart Disease" | "Heparin"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03140631
Recruitment Status : Completed
First Posted : May 4, 2017
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hakan Oral, University of Michigan

Tracking Information
First Submitted Date  ICMJE April 3, 2017
First Posted Date  ICMJE May 4, 2017
Results First Submitted Date  ICMJE August 25, 2018
Results First Posted Date  ICMJE October 23, 2018
Last Update Posted Date October 23, 2018
Actual Study Start Date  ICMJE March 23, 2017
Actual Primary Completion Date November 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
Time to Ambulation [ Time Frame: 0 to 24 hours ]
Total length of time from procedural termination to patient ambulation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03140631 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
Vascular access site complications [ Time Frame: 90 days ]
Occurrence of complications related to access including hematoma, aneurysm, pseudoaneurysm, arteriovenous fistula, access site related major bleeding
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation
Official Title  ICMJE Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation: A Randomized Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Catheter Ablation
Intervention  ICMJE Drug: Protamine Sulfate
Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Protamine Sulfate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2018)
153
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2017)
150
Actual Study Completion Date  ICMJE April 3, 2018
Actual Primary Completion Date November 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03140631
Other Study ID Numbers  ICMJE HUM00117851
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hakan Oral, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hakan Oral, MD University of Michigan
PRS Account University of Michigan
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP