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The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing emergent cardiac surgery during dual antiplatelet therapy.
Blood for measuring platelet function is drawn before induction of anesthesia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One group | Emergency surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Calculated Blood Loss | until postoperative day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| BARC Bleeding | Intracranial bleed within 48 hours, Reoperation after closure of sternotomy for the purpose of controlling bleeding, Transfusion of equal to or more than 5 Units of packed red blood cells within a 48-hour period, Chest tube output of equal to or more than 2 L within a 24-h period. | until postoperative day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients needing emergent cardiac surgery under dual antiplatelet therapy
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Mahla, M.D. | Department of Anesthesia and Intensive Care Medicine, Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine, Department of Surgery, Medical University of Graz | Graz | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27378554 | Derived | Mahla E, Prueller F, Farzi S, Pregartner G, Raggam RB, Beran E, Toller W, Berghold A, Tantry US, Gurbel PA. Does Platelet Reactivity Predict Bleeding in Patients Needing Urgent Coronary Artery Bypass Grafting During Dual Antiplatelet Therapy? Ann Thorac Surg. 2016 Dec;102(6):2010-2017. doi: 10.1016/j.athoracsur.2016.05.003. Epub 2016 Jul 1. |
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184 patients were screened for eligibility. Of these, 17 patients were found to be ineligible for the study.
Therefore the number of actually enrolled patients is 167.
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| ID | Title | Description |
|---|---|---|
| FG000 | One Group | Emergency surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | One Group | Emergency surgery |
| 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 | Calculated Blood Loss | Posted | Median | Inter-Quartile Range | milliters | until postoperative day 5 |
|
|
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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 | One Group | Emergency surgery | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mortality | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth Mahla, MD | Medical University of Graz | 0043 316 385 13027 | elisabeth.mahla@medunigraz.at |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| no platelet function data |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| Secondary | BARC Bleeding | Intracranial bleed within 48 hours, Reoperation after closure of sternotomy for the purpose of controlling bleeding, Transfusion of equal to or more than 5 Units of packed red blood cells within a 48-hour period, Chest tube output of equal to or more than 2 L within a 24-h period. | Posted | Number | participants | until postoperative day 2 |
|
|
|
| 149 |
| 13 |
| 149 |
| 0 |
| 149 |
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