Patients given PR Cryo for Bleeding

New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY
Bleeding+1 More ConditionsPathogen-Reduced Cryoprecipitate - Biological
All Sexes
What conditions do you have?

Study Summary

This trial will compare two blood products to see if one can reduce uncontrolled bleeding in liver and heart patients.

Eligible Conditions
  • Hypofibrinogenemia
  • Bleeding

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

3 Primary · 26 Secondary · Reporting Duration: Daily, approximately 24 months

3 days post procedure
Number of RBCs used perioperatively
Number of cryo or fibrinogen concentrate products used perioperatively
Number of plasma used perioperatively
Number of platelets used perioperatively
Hour 24
Volume in drains (e.g. chest tube for CV surgery)
Daily, approximately 24 months
Overall cost of cryo vs PR cryo, when factoring wastage
Month 24
Number of cryo units wasted by blood bank
Day 30
Length of stay in
Length of stay in ICU
Length of stay in hospital
Need for ventilator
Time on ventilator
Most proximal to end of procedure
Fibrinogen level
Until end of surgery
Time from end of bypass pump for CV surgery
Day 3
Cumulative volume in drains after surgery (e.g., chest tube for CV surgery) at the time of removal
Within 10 minutes to one hour after the end of the first cryo transfusion.
Fibrinogen level at 10mins
Maximum clot firmness at 10mins
Post transfusion FIBTEM amplitude at 10mins
Pre transfusion FIBTEM amplitude at 10mins
Hour 24
Highest fibrinogen level within 24 hours
Lowest fibrinogen level within 24 hours
Day 5
Number of adverse events: fevers
Number of adverse events: infections
Number of adverse events: transfusion reactions
Day 30
Total number of RBCs used over admission
Total number of plasma used over admission
Total number of platelets used over admission
procedure (Time from OR start time to start of cryo transfusion)
Time from OR start time to start of cryo transfusion
procedure (Time from cryo order to start of transfusion)
Time from cryo order to start of transfusion

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2 Treatment Groups

Patients given Traditional Cryo
1 of 2
Patients given PR Cryo
1 of 2

Active Control

Experimental Treatment

302 Total Participants · 2 Treatment Groups

Primary Treatment: Patients given PR Cryo · No Placebo Group · Phase 4

Patients given PR Cryo
Experimental Group · 1 Intervention: Pathogen-Reduced Cryoprecipitate · Intervention Types: Biological
Patients given Traditional Cryo
ActiveComparator Group · 1 Intervention: Traditional Cryoprecipitate · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: daily, approximately 24 months

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,007 Previous Clinical Trials
1,330,651 Total Patients Enrolled
1 Trials studying Bleeding
24 Patients Enrolled for Bleeding
Cerus CorporationIndustry Sponsor
17 Previous Clinical Trials
4,546 Total Patients Enrolled
Melissa CushingPrincipal InvestigatorWeill Medical College of Cornell University

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had heart surgery that involved procedures like bypass grafting, valve repair or replacement, aortic surgery, or ventricular assist device implantation.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

Is recruitment for this research endeavor currently available to participants?

"Data hosted on 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.