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It is common practice to use antifibrinolytic agents before and during cardiopulmonary bypass. They are not without side effects. The investigators want to show that there is no proof of fibrinolysis in standard sternotomy cardiac surgery patients before cardiopulmonary bypass, and that antifibrinolytic agents should only be started on cardiopulmonary bypass.
Double-blind, placebo controlled, prospective study in two groups of 20 patients. Control group (A) receives standard Epsilonaminocaproic acid treatment before cardiopulmonary bypass (10 gr loading dose, and 1 gr/hr infusion), and second group (B) receives placebo. Before start of Epsilonaminocaproic acid/placebo, D-Dimers and Thromboelastography are measured, repeated just before full heparinization. After heparinization group A receives placebo, and group B Epsilonaminocaproic acid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epsilonaminocaproic acid | Experimental | One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo |
|
| Placebo, Antifibrinolytic activity | Placebo Comparator | Placebo: same IV volume as experimental arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epsilonaminocaproic acid | Drug | One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Di-Dimer Increase Before Cardiopulmonary Bypass | Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Value of Thromboelastography as Monitor of Fibrinolysis | Thromboelastography may display if fibrinolysis is present | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Time Between Incision and Cardiopulmonary Bypass | Mean Length of Time from Incision to Cardiopulmonary Bypass | From incision to bypass, up to 3 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pieter JA Van der Starre, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital & Clinics | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Epsilonaminocaproic Acid | One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo. |
| FG001 | Placebo, Antifibrinolytic Activity | Placebo: same IV volume as experimental arm Placebo: Placebo administered in same volume as in experimental arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epsilonaminocaproic Acid | One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo. |
| BG001 | Placebo, Antifibrinolytic Activity |
| 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 | Di-Dimer Increase Before Cardiopulmonary Bypass | Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients. | D-Dimer from preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients | Posted | Median | Full Range | ng/mL | 6 months |
|
Intraoperatively: From Induction to Post-Protamine administration, up to 12 hours
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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 | Epsilonaminocaproic Acid | One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo. No adverse advents to report. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter van der Starre | Stanford University Medical Center | 6507236412 | pieterva@stanford.edu |
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| ID | Term |
|---|---|
| D015119 | Aminocaproic Acid |
| ID | Term |
|---|---|
| D000614 | Aminocaproates |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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|
| Placebo | Drug | Placebo administered in same volume as in experimental arm. |
|
Placebo: same IV volume as experimental arm Placebo: Placebo administered in same volume as in experimental arm. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo: same IV volume as experimental arm
Placebo: Placebo administered in same volume as in experimental arm.
|
|
| Secondary | Value of Thromboelastography as Monitor of Fibrinolysis | Thromboelastography may display if fibrinolysis is present | Posted | Median | Full Range | percentage of clot | 6 months |
|
|
|
| Other Pre-specified | Length of Time Between Incision and Cardiopulmonary Bypass | Mean Length of Time from Incision to Cardiopulmonary Bypass | Posted | Mean | Standard Deviation | Minutes | From incision to bypass, up to 3 hours |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo, Antifibrinolytic Activity | Placebo: same IV volume as experimental arm Placebo: Placebo administered in same volume as in experimental arm. No adverse events to report. | 0 | 20 | 0 | 20 |
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| D009930 |
| Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Estimated Plasma Lysis Post Bypass |
|