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Retrograde autologous priming for Coronary Artery Disease (RAPPER-MAN Trial)

Phase 3
Waitlist Available
Led By Andre Lamy, MD
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 10 minutes before cardiopulmonary bypass
Awards & highlights

RAPPER-MAN Trial Summary

This study is evaluating whether a technique to reduce hemodilution during cardiac surgery is feasible.

Eligible Conditions
  • Fluid Overload
  • Coronary Artery Disease
  • Hemodilution

RAPPER-MAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start to end of cardiopulmonary bypass
This trial's timeline: 3 weeks for screening, Varies for treatment, and start to end of cardiopulmonary bypass for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in hemoglobin concentration during cardiopulmonary bypass
Feasibility Outcomes
Secondary outcome measures
Change in hemoglobin concentration after cardiopulmonary bypass
Other outcome measures
Acute kidney injury
Autologous prime volume
Blood transfusion
+7 more

Side effects data

From 2012 Phase 3 trial • 225 Patients • NCT01176240
13%
Headache
10%
Dizziness
9%
Nausea
7%
Fatigue
6%
Hypertension
5%
Contusion
5%
Excoriation
4%
Skin laceration
4%
Diarrhoea
4%
Oedema peripheral
4%
Blood pressure increased
1%
Abdominal pain upper
1%
Faecaloma
1%
Inguinal hernia
1%
Atrial fibrillation
1%
Bronchitis viral
1%
Upper respiratory tract infection bacterial
1%
Presyncope
1%
Mental status changes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Droxidopa

RAPPER-MAN Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Retrograde autologous priming aloneExperimental Treatment1 Intervention
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 II: Retrograde autologous priming + mannitolExperimental Treatment2 Interventions
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 III: Conventional priming + mannitolExperimental Treatment2 Interventions
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 IV: Conventional priming aloneActive Control1 Intervention
Participants will receive conventional priming alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Retrograde autologous priming
2020
N/A
~110
Mannitol
FDA approved

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
367 Previous Clinical Trials
300,957 Total Patients Enrolled
9 Trials studying Coronary Artery Disease
5,786 Patients Enrolled for Coronary Artery Disease
McMaster UniversityOTHER
880 Previous Clinical Trials
2,597,828 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
269 Patients Enrolled for Coronary Artery Disease
Andre Lamy, MDPrincipal InvestigatorHamilton Health Sciences Corporation
5 Previous Clinical Trials
19,722 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery
Andre Lamy 2022. "Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04870073.
~0 spots leftby Apr 2025
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