Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Patients given Traditional Cryo 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. |
Biological: Traditional Cryoprecipitate
This is the cryoprecipitate already currently being given to patients with a cryo order.
|
| Experimental: Patients given PR Cryo 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. |
Biological: Pathogen-Reduced Cryoprecipitate
This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.
|
Outcome Measures
Primary Outcome Measures
- Total number of RBCs used over admission [Within the first 30 days after surgery.]
- Total number of platelets used over admission [Within the first 30 days after surgery.]
- Total number of plasma used over admission [Within the first 30 days after surgery.]
Secondary Outcome Measures
- Number of cryo or fibrinogen concentrate products used perioperatively [3 days post procedure]
- Number of RBCs used perioperatively [3 days post procedure]
- Number of plasma used perioperatively [3 days post procedure]
- Number of platelets used perioperatively [3 days post procedure]
- Time from OR start time to start of cryo transfusion [procedure (Time from OR start time to start of cryo transfusion)]
- Time from cryo order to start of transfusion [procedure (Time from cryo order to start of transfusion)]
- Number of cryo units wasted by blood bank [Daily, up to approximately 24 months]
- Pre transfusion FIBTEM amplitude at 10mins [Within 10 minutes to one hour after the end of the first cryo transfusion.]
- Post transfusion FIBTEM amplitude at 10mins [Within 10 minutes to one hour after the end of the first cryo transfusion.]
- Maximum clot firmness at 10mins [Within 10 minutes to one hour after the end of the first cryo transfusion.]
- Fibrinogen level at 10mins [Within 10 minutes to one hour after the end of the first cryo transfusion.]
- Highest fibrinogen level within 24 hours [Within 24 hours after surgery]
- Lowest fibrinogen level within 24 hours [Within 24 hours after surgery]
- Cumulative volume in drains after surgery (e.g., chest tube for CV surgery) at the time of removal [Up to approximately 3 days]
- Volume in drains (e.g. chest tube for CV surgery) [At 24 hours after surgery]
- Time from end of bypass pump for CV surgery [Until end of surgery]
- Length of stay in OR [During hospitalization, approximately 5 days to 30 days]
- Length of stay in ICU [During hospitalization, approximately 5 days to 30 days]
- Length of stay in hospital [During hospitalization, approximately 5 days to 30 days]
- Need for ventilator [During hospitalization, approximately 5 days to 30 days]
- Time on ventilator [During hospitalization, approximately 5 days to 30 days]
- Overall cost of cryo vs PR cryo, when factoring wastage [Daily, approximately 24 months]
- Number of adverse events: fevers [Within 5 days of surgery start time]
All fevers that occur during the time frame
- Number of adverse events: infections [Within 5 days of surgery start time]
All infections that occur during the time frame
- Number of adverse events: transfusion reactions [Within 5 days of surgery start time]
All transfusion reactions that occur during the time frame
- Fibrinogen level [Most proximal to end of procedure]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult patients undergoing cardiovascular surgery or liver transplant who receive cryo during surgery during the two year study period.
-
Cardiovascular surgery includes the following procedures:
-
coronary artery bypass grafting
-
valve repair or replacement
-
open thoracic aortic and thoracoabdominal aortic surgery
-
atrial or ventricular septal defects
-
ventricular assist device implantation or revision
-
or any combination of the above.
Exclusion Criteria:
-
Patients who do not receive any cryo product in the OR
-
Patients who are not cardiovascular surgery or liver transplant patients
-
Cardiac transplantation surgery
-
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.
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Patients who receive less than 1 pool (5 units) of cryo
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Pediatric patients (less than 18 years of age).
-
Patients who received both PR cryo and traditional cryo
-
Pregnant women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York-Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
- Cerus Corporation
Investigators
- Principal Investigator: Melissa Cushing, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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