Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-21

Study Completion Date

2022-09-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemodilution Coronary Artery Disease Fluid Overload

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

single-centre, single blinded, 2x2 factorial, cluster randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Retrograde autologous priming + mannitol

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.

Group Type EXPERIMENTAL

Retrograde autologous priming

Intervention Type 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.

Mannitol

Intervention Type 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.

Retrograde autologous priming alone

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.

Group Type EXPERIMENTAL

Retrograde autologous priming

Intervention Type 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.

Conventional priming + mannitol

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.

Group Type EXPERIMENTAL

Mannitol

Intervention Type 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.

Conventional Priming

Intervention Type PROCEDURE

The conventional priming procedure will be used in the standardized cardiopulmonary machine used at the Hamilton General Hospital.

Conventional priming alone

Participants will receive conventional priming alone.

Group Type ACTIVE_COMPARATOR

Conventional Priming

Intervention Type PROCEDURE

The conventional priming procedure will be used in the standardized cardiopulmonary machine used at the Hamilton General Hospital.

Interventions

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Retrograde autologous priming

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.

Intervention Type PROCEDURE

Mannitol

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.

Intervention Type DRUG

Conventional Priming

The conventional priming procedure will be used in the standardized cardiopulmonary machine used at the Hamilton General Hospital.

Intervention Type PROCEDURE

Other Intervention Names

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RAP

Eligibility Criteria

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Inclusion Criteria

1. ≥18 years of age.
2. Undergoing a first-time cardiac surgical procedure (i.e. isolated CABG, isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass (CPB) and median sternotomy.

Exclusion Criteria

1. Left ventricle ejection fraction \<25%
2. Emergency surgery
3. History of bleeding disorder
4. Inherited thromboembolic or infective endocarditis (active)
5. Previous cardiac surgery
6. Severe renal impairment (serum creatinine \>250 μmol/L)
7. Hemoglobin \<80 g/L
8. Thrombocytopenia (\<50,000 platelets per μL)
9. Expected circulatory arrest
10. Body weight ≤50 kg
11. Allergy to mannitol
12. Pregnancy or breast feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No