Phase 4
Completed N=20
Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding
Hypofibrinogenemia · Bleeding
Source: ClinicalTrials.gov NCT05711524 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Total Number of RBCs Used Over Admission — 5.8; 6.7 RBC Units
◆ Published Evidence
Emerging
2citations · ~1 / year
Trial Of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOP-CLOT): study protocol for a single center, prospective, cluster randomized 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.
Linked Publications
-
Trial Of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOP-CLOT): study protocol for a single center, prospective, cluster randomized trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of RBCs Used Over Admission |
5.8; 6.7 | — |
| PRIMARY Total Number of Platelets Used Over Admission |
2.1; 2.1 | — |
| PRIMARY Total Number of Plasma Used Over Admission |
2.7; 3.4 | — |
| SECONDARY Number of Cryo Units Used Perioperatively |
2.3; 2.3 | — |
| SECONDARY Number of RBCs Used Perioperatively |
4.6; 5.9 | — |
| SECONDARY Number of Plasma Used Perioperatively |
2.6; 3.4 | — |
| SECONDARY Number of Platelets Used Perioperatively |
1.8; 2.0 | — |
| SECONDARY Time From Operating Room (OR) Start Time to Start of Cryo Transfusion |
366; 367 | — |
| SECONDARY Time From Cryo Order to Start of Transfusion |
128.3; 88.5 | — |
| SECONDARY Number of Cryo Units Wasted by Blood Bank |
— | — |
| SECONDARY Pre Transfusion FIBTEM Amplitude 10 Min After Start of Clot Formation |
9.6; 8.3 | — |
| SECONDARY Post Transfusion FIBTEM Amplitude at 10 Min After Start of Clot Formation |
— | — |
| SECONDARY Maximum Clot Firmness (MCF) |
— | — |
| SECONDARY Pre-transfusion Fibrinogen Level |
145; 191 | — |
| SECONDARY Highest Fibrinogen Level Within 24 Hours |
210; 212 | — |
| SECONDARY Lowest Fibrinogen Level Within 24 Hours |
194.5; 199.89 | — |
| SECONDARY Cumulative Volume in Drains After Surgery (e.g., Chest Tube for CV Surgery) at the Time of Removal |
— | — |
| SECONDARY Volume in Drains (Chest Tube for CV Surgery) |
897; 749 | — |
| SECONDARY Time From End of Bypass Pump for CV Surgery |
2.75; 2.73 | — |
| SECONDARY Length of Stay in OR |
522; 534 | — |
| SECONDARY Length of Stay in ICU |
8.1; 6.9 | — |
| SECONDARY Length of Stay in Hospital |
12.0; 10.9 | — |
| SECONDARY Need for Ventilator |
99; 96 | — |
| SECONDARY Time on Ventilator |
2.4; 2.6 | — |
| SECONDARY Overall Cost of Cryo vs PR Cryo, When Factoring Wastage |
— | — |
| SECONDARY Number of Participants That Experienced an Adverse Event of Fever |
16; 14 | — |
| SECONDARY Number of Participants That Experienced an Adverse Event of Infection |
6; 4 | — |
| SECONDARY Number of Participants That Experienced an Adverse Event of Transfusion Reaction. |
0; 0 | — |
| SECONDARY Fibrinogen Level |
197; 201 | — |
Eligibility 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.
- Patients who receive less than 1 pool (5 units) of cryo
- Pediatric patients (less than 18 years of age).
- Patients who received both PR cryo and traditional cryo
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT05711524) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.