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Up to 15% of operations in cardio-pulmonary by-pass are complicated by excessive postoperative blood loss, which negatively affects the outcomes. Recently, it has been demonstrated that fibrin clot susceptibility to lysis is a modulator of postoperative blood loss after cardiac surgery for aortic stenosis. Earlier, a preliminary study showed a negative association of postoperative blood loss after coronary artery by-pass grafting (CABG) with fibrin clot lysis time, reflecting susceptibility to fibrinolysis.
In CABG, postoperative blood loss may depend on the operative technique with respect to left internal mammary artery (LIMA) harvesting. LIMA is taken down in virtually all CABG procedures, but harvesting technical details remain at surgeons discretion (skeletonization without opening the pleural cavity vs. pedicled graft with pleura wide open).
The investigators decided to test the hypothesis that fibrin clot properties modulate the postoperative drainage following CABG strongly enough to attenuate the influence of surgical technique by randomizing the patients undergoing CABG with regard to LIMA harvesting technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skeletonized LIMA | Active Comparator | In patients in this arm the left internal mammary artery will be skeletonized without opening of the left pleural cavity during CABG. |
|
| Pedicled LIMA | Active Comparator | In patients in this arm the left internal mammary artery will be harvested as a pedicled graft with wide opening of left pleural cavity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skeletonized LIMA | Procedure | Standard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative chest-tube output after 12 hours | Drainage volume after 12 hours | 12 hours from the end of operation |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative myocardial infarction | Change in myocardial necrosis biomarkers (Troponin T, creatine kinase) during first 48 hours postoperatively | 48 hours after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Mazur, MD | Jagiellonian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The John Paul II Hospital | Krakow | Lesser Poland Voivodeship | 31-202 | Poland |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D019106 | Postoperative Hemorrhage |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized clinical trial with parallel group design. Equal allocation.
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The patient will be blinded to LIMA harvesting technique. The laboratory technicians will be blinded to LIMA harvesting technique.
| Pedicled LIMA | Procedure | Standard CABG - no different form any other procedure of this type except LIMA will be taken down as a pedicled graft with opening the pleura |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |