Observational Safety Study of Clottafact® Fibrinogen Concentrate: Real-World Data in Mexico

Colin-Bracamontes, Ignacio; Pérez-Calatayud, Ángel Augusto; Carrillo-Esper, Raúl; Rodríguez-Ayala, Ernesto; Padilla-Molina, Misael; Posadas-Nava, Alejandro; Olvera-Vázquez, Susana; Hernández-Salgado, Lidia

doi:10.1007/s40261-020-00906-6

Cited by 3 publications

(3 citation statements)

References 26 publications

(27 reference statements)

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“…Intraoperative mortality rates are as high as 30–55%, and overall mortality is as high as 45–68%. Antifibrinolytic therapy and ICT/PE association have not been established; however, TXA or EACA can hinder attempts at clotting dissolution by intravenously administered tPA [ 103 , 104 ]. ICT/PE occurs within 30 min of the reperfusion phase [ 105 , 106 ].…”

Section: Hemostatic Drugsmentioning

confidence: 99%

“…The use of fibrinogen concentrate (FC) overcomes the limitations of cryoprecipitates. Furthermore, it avoids an increase in factor VIII and von Willebrand factor, a prothrombotic factor in patients with cirrhosis [ 104 , 105 , 106 , 107 ]. All products are indicated to actively treat bleeding in patients with congenital fibrinogen deficiency.…”

Section: Hemostatic Drugsmentioning

confidence: 99%

“…Stolt [ 103 ] reported on in vitro samples with fibrinogen concentrate supplementation the effectiveness of correcting coagulation testing resulting in higher plasma fibrinogen concentrations and improved clot strength. However, the selected dose for restoring clot strength in cardiac surgery patients differed among the three groups, and these results have implications for the choice of concentration and dosing [ 104 ].…”

Section: Hemostatic Drugsmentioning

confidence: 99%

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Patient Blood Management in Liver Transplant—A Concise Review

et al. 2023

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Transfusion of blood products in orthotopic liver transplantation (OLT) significantly increases post-transplant morbidity and mortality and is associated with reduced graft survival. Based on these results, an active effort to prevent and minimize blood transfusion is required. Patient blood management is a revolutionary approach defined as a patient-centered, systematic, evidence-based approach to improve patient outcomes by managing and preserving a patient’s own blood while promoting patient safety and empowerment. This approach is based on three pillars of treatment: (1) detecting and correcting anemia and thrombocytopenia, (2) minimizing iatrogenic blood loss, detecting, and correcting coagulopathy, and (3) harnessing and increasing anemia tolerance. This review emphasizes the importance of the three-pillar nine-field matrix of patient blood management to improve patient outcomes in liver transplant recipients.

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Section: Hemostatic Drugsmentioning

confidence: 99%

Section: Hemostatic Drugsmentioning

confidence: 99%

Section: Hemostatic Drugsmentioning

confidence: 99%

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Patient Blood Management in Liver Transplant—A Concise Review

et al. 2023

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Evaluation of Point-of-Care-Directed Coagulation Management in Pediatric Cardiac Surgery

Zajonz,

Edinger,

Hofmann

et al. 2024

Thorac Cardiovasc Surg

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Background Coagulatory alterations are common after pediatric cardiac surgery and can be addressed with point-of-care (POC) coagulation analysis. The aim of the present study is to evaluate a preventive POC-controlled coagulation algorithm in pediatric cardiac surgery. Methods This single-center, retrospective data analysis included patients younger than 18 years who underwent cardiac surgery with cardiopulmonary bypass (CPB) and received a coagulation therapy according to a predefined POC-controlled coagulation algorithm. Patients were divided into two groups (<10 and >10 kg body weight) because of different CPB priming strategies. Results In total, 173 surgeries with the use of the POC-guided hemostatic therapy were analyzed. In 71% of cases, target parameters were achieved and only in one case primary sternal closure was not possible. Children with a body weight ≤10 kg underwent surgical re-evaluation in 13.2% (15/113), and respectively 6.7% (4/60) in patients >10 kg. Hemorrhage in children ≤10 kg was associated with cyanotic heart defects, deeper intraoperative hypothermia, longer duration of CPB, more complex procedures (RACHS-1 score), and with more intraoperative platelets, and respectively red blood cell concentrate transfusions (all p-values < 0.05). In children ≤10 kg, fibrinogen levels were significantly lower over the 12-hour postoperative period (without revision: 3.1 [2.9–3.3] vs. with revision 2.8 [2.3–3.4]). Hemorrhage in children >10 kg was associated with a longer duration of CPB (p = 0.042), lower preoperative platelets (p = 0.026), and over the 12-hour postoperative period lower platelets (p = 0.002) and fibrinogen (p = 0.05). Conclusion The use of a preventive, algorithm-based coagulation therapy with factor concentrates after CPB followed by POC created intraoperative clinical stable coagulation status with a subsequent executable thorax closure, although the presented algorithm in its current form is not superior in the reduction of the re-exploration rate compared to equivalent collectives. Reduced fibrinogen concentrations 12 hours after surgery may be associated with an increased incidence of surgical revisions.

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Fibrinogen and Bleeding in Adult Cardiac Surgery: A Review of the Literature

Ikić

2021

Surgeries

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Background: Fibrinogen is a substrate for blood clots formation. In cardiac surgery, a number of different mechanisms lead to a decrease in fibrinogen levels and consequent impaired haemostasis. Patients undergoing cardiac surgery are therefore frequently exposed to blood loss and allogeneic blood transfusion, which are risk factors associated with morbidity and mortality. Thus, particular efforts in fibrinogen management should be made to decrease bleeding and the need for blood transfusion. Therefore, fibrinogen remains an active focus of investigations from basic science to clinical practice. This review aims to summarise the latest evidence regarding the role of fibrinogen and current practices in fibrinogen management in adult cardiac surgery. Methods: The PubMed database was systematically searched for literature investigating the role and disorders of fibrinogen in cardiac surgery and diagnostic and therapeutic procedures related to fibrinogen deficiency aimed at reducing blood loss and transfusion requirements. Clinical trials and reviews from the last 10 years were included. Results: In total, 146 articles were analysed. Conclusion: The early diagnosis and treatment of fibrinogen deficiency is crucial in maintaining haemostasis in bleeding patients. Further studies are needed to better understand the association between fibrinogen levels, bleeding, and fibrinogen supplementation and their impacts on patient outcomes in different clinical settings.

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Observational Safety Study of Clottafact® Fibrinogen Concentrate: Real-World Data in Mexico

Cited by 3 publications

References 26 publications

Patient Blood Management in Liver Transplant—A Concise Review

Patient Blood Management in Liver Transplant—A Concise Review

Evaluation of Point-of-Care-Directed Coagulation Management in Pediatric Cardiac Surgery

Fibrinogen and Bleeding in Adult Cardiac Surgery: A Review of the Literature

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