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Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery
N/A
Waitlist Available
Led By Gregory Nuttall, MD
Research Sponsored by Mayo Clinic
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 baseline, 30 minutes after cardiopulmonary bypass
Awards & highlights
No Placebo-Only Group
Summary
The researchers are trying to reduce the need for blood transfusions in subjects having surgery that will involve the use of cardiopulmonary bypass. A unit of whole blood will be removed as part of their standard of care prior to going on cardiopulmonary bypass (CPB). This unit is given back to the subject post CPB. This has been shown to reduce the need for blood transfusion in patients.
Eligible Conditions
- Hemorrhage
- Bleeding Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 30 minutes after cardiopulmonary bypass
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 minutes after cardiopulmonary bypass
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Fibrinogen
Change in Platelet count
Change in Prothrombin Time/international normalized ratio (PT/INR)
+2 moreSecondary study objectives
Allogenic Blood Transfusion
Chest Tube Output
Re-operation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Control GroupExperimental Treatment1 Intervention
All patients enrolled in the study will undergo a perioperative cardiac surgical anesthetic care plan standardized to the current institutional protocol utilized for intraoperative medication administration. In this arm, ANH would be clinically appropriate, however, the anesthesiologist determined they would not have ANH preformed. At the conclusion of cardiopulmonary bypass and after protamine administration, Coagulation Laboratory Testing will be drawn from the patients and again 30 minutes later to mirror the time lapse in the ANH group.
Group II: Acute Normovolemic Hemodilution GroupExperimental Treatment1 Intervention
All patients enrolled in the study will undergo a perioperative cardiac surgical anesthetic care plan standardized to the current institutional protocol utilized for intraoperative medication administration. If clinically indicated and appropriate per the discretion of the anesthesiologist, Acute Normovolemic Hemodilution (ANH) blood, about 2 units, will be withdrawn from the patients and stored carefully at room temperature per standard protocol. At the conclusion of cardiopulmonary bypass and after protamine administration, Coagulation Laboratory Testing will be drawn from the patients prior to re-infusing the ANH blood and after the blood has been infused per standard institutional protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coagulation Laboratory Testing
2018
N/A
~80
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,066,044 Total Patients Enrolled
17 Trials studying Hemorrhage
8,043 Patients Enrolled for Hemorrhage
Gregory Nuttall, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
1,707 Total Patients Enrolled
1 Trials studying Hemorrhage
106 Patients Enrolled for Hemorrhage