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The purpose of this study is to compare two different dosing strategies of a drug named protamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Dose Protamine group | Experimental | Participants in the group will receive a one time dose of 250 mg Protamine to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. |
|
| Ratio Dose Protamine Group | Active Comparator | Participants in the group will receive a ratio dose of Protamine in a 1mg per 100 units of heparin ratio to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protamine fixed dose | Drug | 250 mg of protamine intravenously (IV), one time use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Activated Clotting Time | Activated clotting times will be measured using standard coagulation monitor | Baseline (before start of surgery) |
| Activated Clotting Time | Activated clotting times will be measured using standard coagulation monitor | up to 4 hours (after cardiopulmonary bypass surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Protamine Dosing | Additional protamine dose will be measured in milligrams (mg) | Up to 4 hours |
| Chest Tube Output | Measured in milliliters (ml) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Fabbro, DO | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Hospital | Miami | Florida | 33136 | United States | ||
| University of Miami |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed Dose Protamine Group | Participants in the group will receive a one time dose of 250 mg Protamine to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. Protamine fixed dose: 250 mg of protamine intravenously (IV), one time use |
| FG001 | Ratio Dose Protamine Group | Participants in the group will receive a ratio dose of Protamine in a 1mg per 100 units of heparin ratio to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. Protamine ratio dose: 1mg of protamine per 100 units of heparin given intravenously (IV), one time use |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fixed Dose Protamine Group | Participants in the group will receive a one time dose of 250 mg Protamine to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. Protamine fixed dose: 250 mg of protamine intravenously (IV), one time use |
| BG001 | Ratio Dose Protamine Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Activated Clotting Time | Activated clotting times will be measured using standard coagulation monitor | Data was collected for all subjects that completed | Posted | Median | Inter-Quartile Range | seconds | Baseline (before start of surgery) |
|
1 year
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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 | Fixed Dose Protamine Group | Participants in the group will receive a one time dose of 250 mg Protamine to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. Protamine fixed dose: 250 mg of protamine intravenously (IV), one time use |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Fabbro II, DO | University of Miami | 305-689-1106 | mxf790@miami.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 | May 5, 2022 | May 31, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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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| Protamine ratio dose | Drug | 1mg of protamine per 100 units of heparin given intravenously (IV), one time use |
|
| Up to 24 hours |
| Count of Participants Receiving Red Blood Cell Transfusion | All transfusions were recorded in a data log for the count of participants that received a red blood cell transfusion. | Up to 4 hours |
| Miami |
| Florida |
| 33136 |
| United States |
Participants in the group will receive a ratio dose of Protamine in a 1mg per 100 units of heparin ratio to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. Protamine ratio dose: 1mg of protamine per 100 units of heparin given intravenously (IV), one time use |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | 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 |
|
|
|
| Primary | Activated Clotting Time | Activated clotting times will be measured using standard coagulation monitor | Data was collected for all subjects that completed | Posted | Median | Inter-Quartile Range | seconds | up to 4 hours (after cardiopulmonary bypass surgery) |
|
|
|
| Secondary | Additional Protamine Dosing | Additional protamine dose will be measured in milligrams (mg) | Posted | Median | Inter-Quartile Range | milligrams | Up to 4 hours |
|
|
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| Secondary | Chest Tube Output | Measured in milliliters (ml) | Data was collected for all subjects that completed | Posted | Median | Inter-Quartile Range | ml | Up to 24 hours |
|
|
|
| Secondary | Count of Participants Receiving Red Blood Cell Transfusion | All transfusions were recorded in a data log for the count of participants that received a red blood cell transfusion. | Data was collected for all subjects that completed | Posted | Count of Participants | Participants | Up to 4 hours |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Ratio Dose Protamine Group | Participants in the group will receive a ratio dose of Protamine in a 1mg per 100 units of heparin ratio to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery. Protamine ratio dose: 1mg of protamine per 100 units of heparin given intravenously (IV), one time use | 0 | 65 | 0 | 65 | 0 | 65 |
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