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Financial support could not be obtained for the study
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| Name | Class |
|---|---|
| McMaster University | OTHER |
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Hemodilution reduces concentrations of blood constituents: concentration of hemoglobin, red blood cells (hematocrit), physiological ions and coagulation factors that can contribute to impaired hemostasis and increasing the risk of perioperative blood transfusions. This pilot study will assess the feasibility of a large RCT to evaluate 2 techniques for reducing hemodilution during cardiac surgery: 1) retrograde autologous priming and 2) intraoperative mannitol. The aim of this pilot trial is to demonstrate feasibility of a larger trial to evaluate whether retrograde autologous priming and/or mannitol are superior to conventional priming alone.
The use of large volumes of artificial priming fluids is still very high in cardiac surgery for routine CABG surgery with cardiopulmonary bypass. The resulting hemodilution is deleterious for patients and often requires counter measures to maintain fluid balance during and after surgery. Retrograde autologous priming and mannitol are simple low-cost solutions to the problem of hemodilution but their effectiveness, either alone or in combination, is unclear due to a lack of high-quality evidence. RAPPER-MAN is a single-centre 2x2 factorial cluster randomized trial. Participants will be randomly assigned (1:1:1:1 ratio) to the intervention groups: 1) Retrograde autologous priming (≥600 mL) + mannitol (0.3 g/kg bolus), 2) Retrograde autologous priming (≥600 mL) alone, 3) Conventional priming + mannitol (0.3 g/kg bolus), and 4) Conventional priming alone. The primary outcome is the change in hemoglobin concentration during cardiopulmonary bypass. Retrograde autologous priming will be performed within 10 minutes before, and mannitol will be added to the venous reservoir of the CPB machine within 5 minutes before, the start of cardiopulmonary bypass. The results of the larger trial are expected to have broad implications for fluid management in cardiac surgery in Canada.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrograde autologous priming + mannitol | Experimental | Priming solution (≥600 mL) will be removed from the extracorporeal circuit within 10 minutes before the initiation of cardiopulmonary bypass. Priming solution may be removed from 3 locations within the extracorporeal circuit (i.e. arterial, venous and cardioplegia lines) as determined by the perfusionist team. In addition, mannitol will be added as a bolus (0.3 g/kg) to the venous reservoir of the cardiopulmonary bypass machine within 5 min before the start of cardiopulmonary bypass. |
|
| Retrograde autologous priming alone | Experimental | Priming solution (≥600 mL) will be removed from the extracorporeal circuit within 10 minutes before the initiation of cardiopulmonary bypass. Priming solution may be removed from 3 locations within the extracorporeal circuit (i.e. arterial, venous and cardioplegia lines) as determined by the perfusionist team. |
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| Conventional priming + mannitol | Experimental | Participants will receive conventional priming. In addition, mannitol will be added as a bolus (0.3 g/kg) to the venous reservoir of the cardiopulmonary bypass machine within 5 min before the start of cardiopulmonary bypass. |
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| Conventional priming alone | Active Comparator | Participants will receive conventional priming alone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrograde autologous priming | Procedure | Priming solution (≥600 mL) will be removed from the extracorporeal circuit within 10 minutes before the initiation of cardiopulmonary bypass. Priming solution may be removed from 3 locations within the extracorporeal circuit (i.e. arterial, venous and cardioplegia lines) as determined by the perfusionist team. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Outcomes | Feasibility will be established in the pilot phase if all the following criteria are met:
| Start to end of study recruitment, which is anticipated to take 20 weeks |
| Change in hemoglobin concentration during cardiopulmonary bypass | Change in arterial hemoglobin concentration during cardiopulmonary bypass | Start to end of cardiopulmonary bypass |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin concentration after cardiopulmonary bypass | Change in arterial hemoglobin concentration from baseline to discharge | Start of cardiopulmonary bypass to hospital discharge or 5 days maximum (whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood transfusion | Proportion of patients experiencing red blood cell transfusion | Start of surgery to hospital discharge or 5 days maximum (whichever occurs first) |
| Change in oxygen consumption during cardiopulmonary bypass |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre Lamy, MD | Hamilton Health Sciences Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32947294 | Background | Hensley NB, Gyi R, Zorrilla-Vaca A, Choi CW, Lawton JS, Brown CH 4th, Frank SM, Grant MC, Cho BC. Retrograde Autologous Priming in Cardiac Surgery: Results From a Systematic Review and Meta-analysis. Anesth Analg. 2021 Jan;132(1):100-107. doi: 10.1213/ANE.0000000000005151. | |
| 31287556 | Background | Ljunggren M, Skold A, Dardashti A, Hyllen S. The use of mannitol in cardiopulmonary bypass prime solution-Prospective randomized double-blind clinical trial. Acta Anaesthesiol Scand. 2019 Nov;63(10):1298-1305. doi: 10.1111/aas.13445. Epub 2019 Jul 29. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D004487 | Edema |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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single-centre, single blinded, 2x2 factorial, cluster randomized trial
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| Mannitol | Drug | Mannitol will be added as a bolus (0.3 g/kg) to the venous reservoir of the cardiopulmonary bypass machine within 5 min before the start of cardiopulmonary bypass. |
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| Conventional Priming | Procedure | The conventional priming procedure will be used in the standardized cardiopulmonary machine used at the Hamilton General Hospital. |
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Change in oxygen consumption during cardiopulmonary bypass
| Start to end of cardiopulmonary bypass |
| Autologous prime volume | Total prime volume removed from the extracorporeal circuit during the retrograde autologous priming procedure | Within 10 minutes before cardiopulmonary bypass |
| Hyponatremia | Sodium concentration of less than 135 mmol/L (135 mEq/L) | Before and 24 hours after surgery |
| Diuresis | Total volume of urine within 24 hours of surgery | Within 24 hours of surgery |
| Hemofiltration use | Proportion of patients undergoing hemofiltration | During cardiopulmonary bypass |
| Fluid balance | Net fluid balance (intake minus output) calculated using a cumulative fluid chart | Daily in ICU from admission to hospital discharge or 5 days maximum (whichever occurs first) |
| Acute kidney injury | Acute kidney injury as measured by peak postoperative creatinine and KDIGO | Start of surgery to hospital discharge or 5 days maximum (whichever occurs first) |
| Length of hospital stay | Length of hospital stay (days) | Time from admission to hospital discharge or 5 days maximum (whichever occurs first) |
| Major adverse cardiovascular events | Composite outcome of cardiovascular death, non-fatal myocardial infarction or stroke | Start of surgery to hospital discharge or 5 days maximum (whichever occurs first) |
| 29029990 | Background | Task Force on Patient Blood Management for Adult Cardiac Surgery of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology (EACTA); Boer C, Meesters MI, Milojevic M, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Pagano D. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):88-120. doi: 10.1053/j.jvca.2017.06.026. Epub 2017 Sep 30. No abstract available. |
| 25803120 | Background | Trapp C, Schiller W, Mellert F, Halbe M, Lorenzen H, Welz A, Probst C. Retrograde Autologous Priming as a Safe and Easy Method to Reduce Hemodilution and Transfusion Requirements during Cardiac Surgery. Thorac Cardiovasc Surg. 2015 Oct;63(7):628-34. doi: 10.1055/s-0035-1548731. Epub 2015 Mar 24. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |