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The purpose of this study is to evaluate safety and efficacy of three main perfusion methods in surgical repair of coarctation of aorta with aortic arch hypoplasia in infants.
Three perfusion techniques of visceral protection will be assessed - deep hypothermic circulatory arrest, selective antegrade cerebral perfusion and double arterial cannulation (perfusion of brachiocephalic artery with thoracic descending aorta by two arterial cannulas)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep hypothermic arrest | Active Comparator | Surgical repair of coarctation of aorta under deep hypothermic circulatory arrest |
|
| Selective antegrade cerebral perfusion | Active Comparator | Surgical repair of coarctation of aorta using selective antegrade cerebral perfusion |
|
| Double arterial cannulation | Active Comparator | Surgical repair of coarctation of aorta using cerebral antegrade perfusion with descending aortic cannulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical repair of coarctation of aorta | Procedure | Surgical repair of coarctation of aorta with aortic arch hypoplasia under CPB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events in early postoperative period | Number of participants with adverse events that are related to treatment (including hospital mortality, renal injury (pRIFLE criteria), neurological complications (confirmed by CT or MRI) ) | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of inotropic support (inotropic score) | through ICU stay, an average of 3 weeks | |
| Intraoperative blood loss (ml) | intraoperatively | |
| Temperature of cooling (C) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuriy Y Kulyabin, MD | Contact | +79538889890 | y.y.coolyabin@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation | Recruiting | Novosibirsk | 630055 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32446921 | Derived | Kulyabin YY, Bogachev-Prokophiev AV, Soynov IA, Omelchenko AY, Zubritskiy AV, Gorbatykh YN. Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Neonates: A Pilot Prospective Randomized Study. Semin Thorac Cardiovasc Surg. 2020 Winter;32(4):860-871. doi: 10.1053/j.semtcvs.2020.04.015. Epub 2020 May 22. |
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| ID | Term |
|---|---|
| D001017 | Aortic Coarctation |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| intraoperatively |
| Duration of CPB (min) | intraoperatively |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |