Status:
WITHDRAWN
Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
McMaster University
Conditions:
Hemodilution
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Hemodilution reduces concentrations of blood constituents: concentration of hemoglobin, red blood cells (hematocrit), physiological ions and coagulation factors that can contribute to impaired hemosta...
Detailed Description
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...
Eligibility Criteria
Inclusion
- ≥18 years of age.
- 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
- Left ventricle ejection fraction \<25%
- Emergency surgery
- History of bleeding disorder
- Inherited thromboembolic or infective endocarditis (active)
- Previous cardiac surgery
- Severe renal impairment (serum creatinine \>250 μmol/L)
- Hemoglobin \<80 g/L
- Thrombocytopenia (\<50,000 platelets per μL)
- Expected circulatory arrest
- Body weight ≤50 kg
- Allergy to mannitol
- Pregnancy or breast feeding
Key Trial Info
Start Date :
September 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04870073
Start Date
September 21 2022
End Date
September 21 2022
Last Update
February 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2