Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborator: McMaster University
• Treatments: Mannitol

Criteria

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