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Autologous Blood Management for Postoperative Hemorrhage
N/A
Waitlist Available
Led By Angela R Neufeld, MD
Research Sponsored by University of Alberta
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 12 months
Awards & highlights
Study Summary
This trial will test a protocol to see if using a patient's own blood is as good as donated blood products to reduce blood loss in heart surgery.
Who is the study for?
Adults over 18 years old who are having heart surgery at the Mazankowski Alberta Heart Institute and are at high risk for blood clotting problems can join. The trial is not open to those who don't meet these specific conditions.Check my eligibility
What is being tested?
The study compares two ways of managing blood loss during heart surgery: one group will use their own donated blood, while the other will receive standard care with transfusions from donors. The aim is to see if using one's own blood reduces bleeding, need for donor blood, and complications.See study design
What are the potential side effects?
Potential side effects may include reactions related to transfusion such as fever, allergic reactions or infection. Using one's own blood might reduce these risks but could also have issues like anemia due to pre-surgery donation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adequacy of recruitment.
Secondary outcome measures
24-Hour chest tube output.
Dose of fibrinogen.
Dose of prothrombin complex concentrates.
+12 moreOther outcome measures
Number of major protocol deviations (adherence).
Number of participants with inadvertent unblinding of the intensive care clinicians.
Number of participants without complete follow-up.
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Autologous Whole Blood ManagementExperimental Treatment1 Intervention
Intraoperative high volume autologous whole blood withdrawal prior to cardiopulmonary bypass (CPB) with re-transfusion following weaning from CPB.
Group II: Allogenic and Derivative TransfusionActive Control1 Intervention
Control arm participants will receive standard care involving transfusion of plasma, platelets, cryoprecipitate, and/or lyophilized concentrates following weaning from CPB.
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Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,113 Total Patients Enrolled
University Hospital FoundationOTHER
7 Previous Clinical Trials
1,322 Total Patients Enrolled
Alberta Innovates Health SolutionsOTHER
53 Previous Clinical Trials
94,361 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bacterial infection in my blood or heart.I have severe narrowing in my carotid artery.My kidney function is not normal.My blood thinning medication for heart surgery is not based on heparin.I am over 85 years old.I have a blood disorder affecting my hemoglobin.I am 18 years old or older.I use oxygen at home for my chronic lung condition.I am at high risk for developing blood clotting problems.I weigh less than 55 kg.I am experiencing severe breathing problems.My liver is not working properly.I need surgery urgently.I have had a recent heart attack or severe chest pain.I am a surgical patient at the Mazankowski Alberta Heart Institute.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous Whole Blood Management
- Group 2: Allogenic and Derivative Transfusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment restricted to seniors aged 85 or below for this experiment?
"This clinical trial has set the lower age limit at 18 and established an upper bound of 85, in compliance with its inclusion criteria."
Answered by AI
Could I be accepted as a participant in this research?
"To be eligible for this medical trial, a patient must have postoperative bleeding and lie between 18 to 85 years of age. Currently, 64 individuals are being actively recruited."
Answered by AI
Is the enrollment window still open for this research project?
"Per the clinicaltrials.gov site, this research is not currently recruiting volunteers as of May 25th 2023. Although there are no available positions in this trial, 363 other trials hosted on the same platform are actively searching for participants."
Answered by AI
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