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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protamine Sulfate | Drug | Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Ambulation | Total length of time from procedural termination to patient ambulation | 0 to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants Who Experienced Vascular Access Site Complications | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hakan Oral, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Medicine | Ann Arbor | Michigan | 48109 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Ambulation | Total length of time from procedural termination to patient ambulation | Posted | Mean | Standard Deviation | minutes | 0 to 24 hours |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor vascular complication | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hakan Oral | Michigan Medicine | 734-936-8214 | oralh@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2017 | Aug 24, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011479 | Protamines |
| ID | Term |
|---|---|
| D009687 | Nuclear Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009698 | Nucleoproteins |
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| checked at 30 and 90 days |
| 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. Protamine Sulfate: Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kilograms/(meter squared) |
|
| CHAD2Ds2-VASc Score | 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. | Mean | Standard Deviation | scores on a scale |
|
| Warfarin use | this is a count of the number of participants taking the medication warfarin during study enrollment | Count of Participants | Participants |
|
| NOAC use | 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 | Count of Participants | Participants |
|
| Hemoglobin | Mean | Standard Deviation | g/dl |
|
| Platelets | Mean | Standard Deviation | 10^3 platelets/mm^3 |
|
| INR | Mean | Standard Deviation | ratio |
|
| Creatinine | Mean | Standard Deviation | mg/dl |
|
|
|
|
| Secondary | Count of Participants Who Experienced Vascular Access Site Complications | 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) | Posted | Count of Participants | Participants | checked at 30 and 90 days |
|
|
|
|
| 1 |
| 73 |
| 1 |
| 73 |
| 4 |
| 73 |
| EG001 | 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. Protamine Sulfate: Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects. | 0 | 77 | 1 | 77 | 5 | 77 |
| Major vascular complication | Vascular disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |