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Coagulation Factor
Pathogen-Reduced vs Traditional Cryoprecipitate for Bleeding
Phase 4
Recruiting
Led By Melissa Cushing
Research Sponsored by Weill Medical College of Cornell University
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 daily, approximately 24 months
Awards & highlights
Study Summary
This trial will compare two blood products to see if one can reduce uncontrolled bleeding in liver and heart patients.
Who is the study for?
This trial is for adults undergoing cardiovascular surgery or liver transplant who will receive cryoprecipitate during the procedure. It excludes those not receiving this product, cardiac transplant patients, anyone given the wrong product, recipients of less than one pool of cryo, children under 18, and pregnant women.Check my eligibility
What is being tested?
The study compares pathogen-reduced cryoprecipitate with traditional cryoprecipitate in managing early bleeding during surgery. The aim is to see if immediate access to thawed blood products can prevent severe hemorrhage and reduce the need for additional transfusions.See study design
What are the potential side effects?
While specific side effects are not listed here, both types of cryoprecipitates may cause reactions related to blood transfusion such as allergic reactions, fever, lung injury or transmission of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ daily, approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily, approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total number of RBCs used over admission
Total number of plasma used over admission
Total number of platelets used over admission
Secondary outcome measures
Cumulative volume in drains after surgery (e.g., chest tube for CV surgery) at the time of removal
Fibrinogen level
Fibrinogen level at 10mins
+23 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Patients given PR CryoExperimental Treatment1 Intervention
These are the liver transplant and cardiothoracic (LT and CT) patients that will be given PR cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month.
Group II: Patients given Traditional CryoActive Control1 Intervention
These are the liver transplant and cardiothoracic (LT and CT) patients that will be given traditional cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,315,993 Total Patients Enrolled
1 Trials studying Bleeding
24 Patients Enrolled for Bleeding
Cerus CorporationIndustry Sponsor
18 Previous Clinical Trials
4,566 Total Patients Enrolled
Melissa CushingPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not a cardiovascular surgery or liver transplant patient.I have had a heart transplant surgery.I have received less than 5 units of cryoprecipitate.I am under 18 years old.I have not received any cryo treatments in the operating room.I am an adult who will receive cryotherapy during my heart surgery or liver transplant within the next two years.I have undergone both PR and traditional cryotherapy.I have had heart or major blood vessel surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Patients given Traditional Cryo
- Group 2: Patients given PR Cryo
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has the FDA approved the use of Patients given PR Cryo?
"After careful consideration, our team at Power gave PR Cryo a score of 3 due to it being cleared for Phase 4 clinical trials. This denotes that this treatment is endorsed as safe by regulatory authorities."
Answered by AI
Is recruitment for this research endeavor currently available to participants?
"Data hosted on clinicaltrials.gov has revealed that this medical research project is not presently seeking patients, even though it was initially posted and recently revised in February of 2023. Nevertheless, there are 375 different studies actively recruiting participants at the present time."
Answered by AI
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