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
Phase 4
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
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
Biological
Experimental Group · 1 Intervention: Pathogen-Reduced Cryoprecipitate · Intervention Types: BiologicalPatients given Traditional Cryo
Biological
ActiveComparator Group · 1 Intervention: Traditional Cryoprecipitate · Intervention Types: BiologicalTrial 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.
References
- Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McKenzie JE. Appropriate statistical methods were infrequently used in cluster-randomized crossover trials. J Clin Epidemiol. 2016 Jun;74:40-50. doi: 10.1016/j.jclinepi.2015.11.013. Epub 2015 Nov 26.
- Saland LC. Effects of reserpine administration on the fine structure of the rat pars intermedia. Cell Tissue Res. 1978 Nov 9;194(1):115-23. doi: 10.1007/BF00209237.
- Cushing MM, Fitzgerald MM, Harris RM, Asmis LM, Haas T. Influence of cryoprecipitate, Factor XIII, and fibrinogen concentrate on hyperfibrinolysis. Transfusion. 2017 Oct;57(10):2502-2510. doi: 10.1111/trf.14259. Epub 2017 Jul 21.
- Cushing MM, Haas T, Karkouti K, Callum J. Which is the preferred blood product for fibrinogen replacement in the bleeding patient with acquired hypofibrinogenemia-cryoprecipitate or fibrinogen concentrate? Transfusion. 2020 Jun;60 Suppl 3:S17-S23. doi: 10.1111/trf.15614. Epub 2020 Jun 1.
- Fenderson JL, Meledeo MA, Rendo MJ, Peltier GC, McIntosh CS, Davis KW, Corley JB, Cap AP. Hemostatic characteristics of thawed, pooled cryoprecipitate stored for 35 days at refrigerated and room temperatures. Transfusion. 2019 Apr;59(S2):1560-1567. doi: 10.1111/trf.15180.
- Bulkley GB, Wheaton LG, Strandberg JD, Zuidema GD. Assessment of small intestinal recovery from ischemic injury after segmental, arterial, venous, and arteriovenous occlusion. Surg Forum. 1979;30:210-3. No abstract available.
- Hsien S, Dayton JD, Chen D, Stock A, Bacha E, Cushing MM, Nellis ME. Hemostatic efficacy of pathogen-reduced platelets in children undergoing cardiopulmonary bypass. Transfusion. 2022 Feb;62(2):298-305. doi: 10.1111/trf.16768. Epub 2021 Dec 13.
- Lokhandwala PM, O'Neal A, Patel EU, Brunker PAR, Gehrie EA, Zheng G, Kickler TS, Ness PM, Tobian AAR. Hemostatic profile and safety of pooled cryoprecipitate up to 120 hours after thawing. Transfusion. 2018 May;58(5):1126-1131. doi: 10.1111/trf.14550. Epub 2018 Feb 25.
- Thomson C, Sobieraj-Teague M, Scott D, Duncan E, Abraham S, Roxby D. Extending the post-thaw viability of cryoprecipitate. Transfusion. 2021 May;61(5):1578-1585. doi: 10.1111/trf.16366. Epub 2021 Mar 17.
- 2023. "Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05711524.
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 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." - Anonymous Online Contributor
Unverified Answer