Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05711524
Other study ID # 22-04024649
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 1, 2023
Est. completion date March 2025

Study information

Verified date September 2023
Source Weill Medical College of Cornell University
Contact Melissa Cushing
Phone 212-746-3527
Email mec2013@med.cornell.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided. Participants will be given one of the two FDA-approved blood products.


Description:

Immediately replacing fibrinogen in perioperative bleeding patients with acquired fibrinogen deficiency improves outcomes. The product that is primarily used for fibrinogen replacement in the US, cryoprecipitate (cryo), must be stored frozen and expires six hours after thawing, resulting in a delay in transfusion of approximately 50 minutes from the time it is ordered, as well as unnecessary transfusion of more readily available but not indicated blood components that are transfused while the patients waits for cryo . A modified version of the product, pathogen reduced (PR) cryo, is now FDA approved and can be thawed and stored for 5 days, allowing the product to be available immediately when needed. In this quality improvement study, the investigators will compare the effect that readily available, pre-thawed PR cryo has on transfusion practice in cardiovascular and liver transplant patients who receive PR cryo versus those who receive traditional cryo by randomizing cryo transfusions in the blood bank by month to all cryo or all PR cryo. All clinical decisions, including the need for cryo, and laboratory testing will occur per standard of care.


Recruitment information / eligibility

Status Recruiting
Enrollment 302
Est. completion date March 2025
Est. primary completion date March 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult patients undergoing cardiovascular surgery or liver transplant who receive cryo during surgery during the two year study period. 2. Cardiovascular surgery includes the following procedures: 1. coronary artery bypass grafting 2. valve repair or replacement 3. open thoracic aortic and thoracoabdominal aortic surgery 4. atrial or ventricular septal defects 5. ventricular assist device implantation or revision 6. or any combination of the above. Exclusion Criteria: 1. Patients who do not receive any cryo product in the OR 2. Patients who are not cardiovascular surgery or liver transplant patients 3. Cardiac transplantation surgery 4. Patients who receive a product in error within either the cryo time period or the PR cryo time period. For example, PR cryo during a cryo month or cryo during a PR cryo time month. 5. Patients who receive less than 1 pool (5 units) of cryo 6. Pediatric patients (less than 18 years of age). 7. Patients who received both PR cryo and traditional cryo 8. Pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Traditional Cryoprecipitate
This is the cryoprecipitate already currently being given to patients with a cryo order.
Pathogen-Reduced Cryoprecipitate
This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.

Locations

Country Name City State
United States New York-Presbyterian Hospital/Weill Cornell Medical Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Weill Medical College of Cornell University Cerus Corporation

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Total number of RBCs used over admission Within the first 30 days after surgery.
Primary Total number of platelets used over admission Within the first 30 days after surgery.
Primary Total number of plasma used over admission Within the first 30 days after surgery.
Secondary Number of cryo or fibrinogen concentrate products used perioperatively 3 days post procedure
Secondary Number of RBCs used perioperatively 3 days post procedure
Secondary Number of plasma used perioperatively 3 days post procedure
Secondary Number of platelets used perioperatively 3 days post procedure
Secondary Time from OR start time to start of cryo transfusion procedure (Time from OR start time to start of cryo transfusion)
Secondary Time from cryo order to start of transfusion procedure (Time from cryo order to start of transfusion)
Secondary Number of cryo units wasted by blood bank Daily, up to approximately 24 months
Secondary Pre transfusion FIBTEM amplitude at 10mins Within 10 minutes to one hour after the end of the first cryo transfusion.
Secondary Post transfusion FIBTEM amplitude at 10mins Within 10 minutes to one hour after the end of the first cryo transfusion.
Secondary Maximum clot firmness at 10mins Within 10 minutes to one hour after the end of the first cryo transfusion.
Secondary Fibrinogen level at 10mins Within 10 minutes to one hour after the end of the first cryo transfusion.
Secondary Highest fibrinogen level within 24 hours Within 24 hours after surgery
Secondary Lowest fibrinogen level within 24 hours Within 24 hours after surgery
Secondary Cumulative volume in drains after surgery (e.g., chest tube for CV surgery) at the time of removal Up to approximately 3 days
Secondary Volume in drains (e.g. chest tube for CV surgery) At 24 hours after surgery
Secondary Time from end of bypass pump for CV surgery Until end of surgery
Secondary Length of stay in OR During hospitalization, approximately 5 days to 30 days
Secondary Length of stay in ICU During hospitalization, approximately 5 days to 30 days
Secondary Length of stay in hospital During hospitalization, approximately 5 days to 30 days
Secondary Need for ventilator During hospitalization, approximately 5 days to 30 days
Secondary Time on ventilator During hospitalization, approximately 5 days to 30 days
Secondary Overall cost of cryo vs PR cryo, when factoring wastage Daily, approximately 24 months
Secondary Number of adverse events: fevers All fevers that occur during the time frame Within 5 days of surgery start time
Secondary Number of adverse events: infections All infections that occur during the time frame Within 5 days of surgery start time
Secondary Number of adverse events: transfusion reactions All transfusion reactions that occur during the time frame Within 5 days of surgery start time
Secondary Fibrinogen level Most proximal to end of procedure
See also
  Status Clinical Trial Phase
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT04058223 - Comparison of the Short-term Outcomes of Using DST and PPH Staplers in the Treatment of Grade III and IV Hemorrhoids
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Completed NCT04590898 - Peri-device Leakage Closure After LAAO
Active, not recruiting NCT05563883 - Atrial Fibrillation and Cancer: a Nationwide French Cohort Study
Not yet recruiting NCT04537533 - Tranexamic Acid Infusion in Low Dose Versus in High Dose for Reducing Blood Loss in Radical Cystectomy Operations Phase 4
Withdrawn NCT02851940 - Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids N/A
Completed NCT02722720 - Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral N/A
Recruiting NCT02279186 - Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section Phase 4
Active, not recruiting NCT02244853 - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease N/A
Completed NCT02245854 - Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps N/A
Completed NCT02980497 - Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study N/A
Completed NCT02092415 - Assessment of Limb Perfusion During Junctional Tourniquet N/A
Not yet recruiting NCT01438736 - Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern? Phase 4
Completed NCT00515541 - Lovaza's Effect on the Activation of Platelets Phase 2
Completed NCT00143715 - Oral Vitamin K for Warfarin Associated Coagulopathy Phase 3
Terminated NCT03954314 - DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery Phase 3
Recruiting NCT05945680 - Tranexamic Acid in Breast Esthetic Surgery. Phase 4
Recruiting NCT03783182 - Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy Phase 4
Not yet recruiting NCT05464394 - Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass Phase 3