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Trial record 18 of 172 for:    "Heart Disease" | "Heparin"

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
Sponsor:
Information provided by (Responsible Party):
Hakan Oral, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Atrial Fibrillation
Catheter Ablation
Intervention Drug: Protamine Sulfate
Enrollment 153
Recruitment Details  
Pre-assignment Details 153 patients were enrolled in the trial; however, three patients were removed from the trial before treatment allocation due to physician discretion. These patients never received any treatments and were not included in the analysis.
Arm/Group Title Control Protamine
Hide Arm/Group Description Patients in the control arm will undergo routine post-procedure management prior to removal of vascular sheaths. This includes routine measurements of activated clotting time (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.

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. Activated clotting time (ACT) levels will then be monitored with a goal ACT of <200s or return to preprocedural baseline prior to removal of vascular sheaths.

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

Period Title: Overall Study
Started 73 77
Completed 73 77
Not Completed 0 0
Arm/Group Title Control Protamine Total
Hide Arm/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.

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.

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

Total of all reporting groups
Overall Number of Baseline Participants 73 77 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 77 participants 150 participants
66  (9) 63  (12) 63  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 77 participants 150 participants
Female
25
  34.2%
31
  40.3%
56
  37.3%
Male
48
  65.8%
46
  59.7%
94
  62.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
BMI  
Mean (Standard Deviation)
Unit of measure:  Kilograms/(meter squared)
Number Analyzed 73 participants 77 participants 150 participants
31  (7) 32  (6) 32  (6)
CHAD2Ds2-VASc Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 73 participants 77 participants 150 participants
2.2  (1.2) 2.1  (1.2) 2.1  (1.2)
[1]
Measure Description: Summation of weighted risk factor points: Congestive Heart Failure (1), Hypertension (1), Age 75 years or older (2), Diabetes Mellitus (1), Stroke/Transient Ischemic Attack/Thromboembolic Event (2), Vascular Disease (1), Age 65 to 74 Years (1), Female Sex (1). The minimum score is 0 and represents the lowest risk of thromboembolic events and 9 is the maximum score and represents the highest risk.
Warfarin use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 77 participants 150 participants
14
  19.2%
14
  18.2%
28
  18.7%
[1]
Measure Description: this is a count of the number of participants taking the medication warfarin during study enrollment
NOAC use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 77 participants 150 participants
59
  80.8%
63
  81.8%
122
  81.3%
[1]
Measure Description: this is a count of the number of participants taking a medication in the class of NOAC (novel oral anticoagulants) at the time of study enrollment
Hemoglobin  
Mean (Standard Deviation)
Unit of measure:  G/dl
Number Analyzed 73 participants 77 participants 150 participants
13.7  (1.6) 14.4  (1.2) 14.1  (1.4)
Platelets  
Mean (Standard Deviation)
Unit of measure:  10^3 platelets/mm^3
Number Analyzed 73 participants 77 participants 150 participants
194  (67) 182  (72) 188  (70)
INR  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 73 participants 77 participants 150 participants
1.4  (0.6) 1.3  (0.5) 1.4  (0.6)
Creatinine  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 73 participants 77 participants 150 participants
1.0  (0.8) 1.0  (0.3) 1.0  (0.6)
1.Primary Outcome
Title Time to Ambulation
Hide Description Total length of time from procedural termination to patient ambulation
Time Frame 0 to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Protamine
Hide Arm/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.

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.

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

Overall Number of Participants Analyzed 73 77
Mean (Standard Deviation)
Unit of Measure: minutes
480  (92) 316  (80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Protamine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Count of Participants Who Experienced Vascular Access Site Complications
Hide Description 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)
Time Frame checked at 30 and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Protamine
Hide Arm/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.

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.

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

Overall Number of Participants Analyzed 73 77
Measure Type: Count of Participants
Unit of Measure: Participants
30 days
4
   5.5%
6
   7.8%
90 days
4
   5.5%
6
   7.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Protamine
Comments number of participants who experienced a vascular access site complication at 90 days
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Protamine
Hide Arm/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.

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.

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

All-Cause Mortality
Control Protamine
Affected / at Risk (%) Affected / at Risk (%)
Total   1/73 (1.37%)      0/77 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Control Protamine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/73 (1.37%)      1/77 (1.30%)    
Nervous system disorders     
Stroke   1/73 (1.37%)  1 0/77 (0.00%)  0
Vascular disorders     
Major vascular complication   0/73 (0.00%)  0 1/77 (1.30%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Protamine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/73 (5.48%)      5/77 (6.49%)    
Vascular disorders     
Minor vascular complication   4/73 (5.48%)  4 5/77 (6.49%)  5
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hakan Oral
Organization: Michigan Medicine
Phone: 734-936-8214
EMail: oralh@med.umich.edu
Layout table for additonal information
Responsible Party: Hakan Oral, University of Michigan
ClinicalTrials.gov Identifier: NCT03140631     History of Changes
Other Study ID Numbers: HUM00117851
First Submitted: April 3, 2017
First Posted: May 4, 2017
Results First Submitted: August 25, 2018
Results First Posted: October 23, 2018
Last Update Posted: October 23, 2018