RiaSTAP (fibrinogen concentrate (human)) / CSL Behring - LARVOL DELTA

Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery (clinicaltrials.gov) - P3 | N=90 | Recruiting | Sponsor: CSL Behring | Not yet recruiting ➔ Recruiting

Enrollment open • Surgery

A Single Center Approach to Managing Hospitalized Patients with Quantitative Fibrinogen Deficiency That Cost-Saving and Maintains High-Quality, Evidence-Based Care (ASH 2024) - "Guidelines recommend using cryoprecipitate (CP) or fibrinogen concentrates (FC) for replacement. Of the two FC with equal efficacy, using FiB instead of RiA is more cost-saving (36%) to our institution. It highlights the need for a larger study of healthcare utilization and cost-effectiveness analysis paired with measurable outcomes of both FC."

Clinical • HEOR • Cardiovascular • Hematological Disorders • Infectious Disease • Pediatrics

Ability of Coagulation Tests to Assess Hemotherapeutic Agent Response Testing (ASH 2024) - "HA agents were Humate-P, CSL Behring (CSL), King of Prussia, PA for hemophilia and VWD; HemosIL normal assayed plasma, Instrumentation Laboratory, Bedford, MA for dilution; RiaSTAP, CSL for hypofibrinogenemia; reagent grade F : VIIa, Enzyme Research Laboratories, South Bend, IN for F : VII deficiency...Optimizing doses of HA may improve MCTS performance. If MCTS can perform automated HART, treatment truly targeted to each patient's unique coagulopathy may become a reality."

Hematological Disorders • Hemophilia • Rare Diseases • Thrombosis

Medication Use Evaluation of RiaSTAP in a Teaching Hospital (ASHP 2024) - No abstract available

Clinical

Resuscitation Strategies in Major Obstetric Hemorrhage in the Setting of Placenta Accreta Spectrum (ASA 2024) - "With an EBL of 11.5 liters, 25U pRBCs, 17U FFP, 6U platelets, 2 grams RiaSTAP, and 10U cryoprecipitate were transfused. This case demonstrates the importance of communication and aggressive resuscitation strategies in the setting of massive hemorrhage."

Anesthesia • Gynecology • Hematological Disorders • Obstetrics

A Randomized Controlled Trial Comparing Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness. (PubMed, Anesth Analg) - "In contrast to previous in vitro studies, we found that the effect of FibCLOT on MCF and CT was not significantly greater than that of RiaSTAP in cardiac surgery patients. Further studies in other clinical settings are warranted."

Journal • Cardiovascular

Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery (clinicaltrials.gov) - P3 | N=90 | Not yet recruiting | Sponsor: CSL Behring

New P3 trial

Effect of In Vivo Administration of Fibrinogen Concentrate Versus Cryoprecipitate on Ex Vivo Clot Degradation in Neonates Undergoing Cardiac Surgery. (PubMed, Anesth Analg) - P3 | "Neonates who received fibrinogen concentrate, as compared to cryoprecipitate, have similar perioperative ex vivo clot degradation with faster degradation at 24 hours postsurgery, less post-CPB blood transfusions, and no increased bleeding or thrombotic complications. Our findings suggest that fibrinogen concentrate adequately restores hemostasis and reduces transfusions in neonates after CPB without increased bleeding or thrombosis risk."

Journal • Preclinical • Surgery • Cardiovascular • Critical care • Hematological Disorders • Thrombosis

Phenotypic characterisation of congenital fibrinogen disorders in Australia (ISTH 2024) - "Data on 28 CFD patients from three Australian sites were collected. 17/28 (61%) were female. In terms of subtype, 1/28 (4%) had afibrinogenemia, 12/28 (43%) hypofibrinogenemia, 14/28 (54%) dysfibrinogenemia and 1/28 (4%) unclassified."

Hematological Disorders • Hemophilia • Obstetrics • Postpartum Hemorrhage • Rare Diseases

Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP®/Haemocomplettan® P). (PubMed, Clin Appl Thromb Hemost) - "Post-marketing data and clinical studies demonstrate a low rate of ADRs, including TEEs, with fibrinogen concentrate treatment. These findings suggest a favorable safety profile of fibrinogen concentrate, placing it among the first-line treatments effective for managing intraoperative hemostatic bleeding."

Journal • Retrospective data • Review • Cardiovascular • Pediatrics

PROPHYLACTIC OR POST-TRAUMATIC TREATMENT OF HYPOFIBRINOGENEMIA AND DYSFIBRINOGENEMIA WITH FIBRGYA IN EIGHT CLINICAL CASES (THSNA 2024) - "Methods/ We present eight clinical cases of patients with hypo- or dysfibrinogenemia that were effectively treated with a pooled, plasma-derived fibrinogen concentrate (FIBRYGA) either prophylactically for elective or urgent surgery, or post-traumatic injury. For the majority (86%) of our patients described here with CH and CD, FIBRYGA was well tolerated and effective in preventing post procedural or post traumatic bleeding complications. The post procedural bleeding noted in one patient may have been due to inadequate fibrinogen concentration or other comorbid conditions. Further clinical studies are needed to determine the role of FIBRGYA and other HFC in the treatment of patients with CFD."

Clinical • Cardiovascular • Diabetes • Hematological Disorders • Hypertension • Immunology • Metabolic Disorders • Pain • Peripheral Arterial Disease • Type 2 Diabetes Mellitus

EDIPORE: Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: IRCCS Policlinico S. Donato | Recruiting ➔ Completed

Trial completion • Heart Failure

PRETIC: Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. (clinicaltrials.gov) - P1/2 | N=79 | Completed | Sponsor: Banc de Sang i Teixits | Active, not recruiting ➔ Completed | N=60 ➔ 79

Enrollment change • Trial completion • Hematological Disorders • Mood Disorders

EDIPORE: Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: IRCCS Policlinico S. Donato

Trial completion date • Trial primary completion date • Heart Failure

Prophylaxis and Treatment of Bleeding or Thrombosis with Fibrinogen Concentrate (Fibryga) in Patients with Congenital Hypofibrinogenemia or Dysfibrinogenemia (ASH 2023) - "The post procedural bleeding noted in one patient may have been due to inadequate fibrinogen concentration or other comorbid conditions. Further clinical studies are needed to determine the role of FIBRGYA and other HFC in the treatment of patients with CFD, especially those with CD."

Clinical • Cardiovascular • Diabetes • Hematological Disorders • Hypertension • Immunology • Metabolic Disorders • Pain • Peripheral Arterial Disease • Thrombosis • Type 2 Diabetes Mellitus

PRETIC: Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. (clinicaltrials.gov) - P1/2 | N=60 | Active, not recruiting | Sponsor: Banc de Sang i Teixits | Trial completion date: Mar 2023 ➔ Oct 2023

Trial completion date • Hematological Disorders • Mood Disorders

EDIPORE: Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: IRCCS Policlinico S. Donato | Not yet recruiting ➔ Recruiting

Enrollment open • Heart Failure

Long-term safety of a fibrinogen concentrate (RiaSTAP®/Haemocomplettan® P): analysis of more than 35 years of pharmacovigilance data (ISICEM 2023) - "Pharmacovigilance data and clinical studies revealed that treatment with fibrinogen concentrate is associated with few ADRs and a low TEE rate across indications. Overall, fibrinogen concentrate showed a favorable safety profile."

Adverse events • Clinical • Cardiovascular • Immunology

EDIPORE: Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: IRCCS Policlinico S. Donato

New P2 trial • Heart Failure

Influence of Fibrinogen Concentrate on Neonatal Clot Structure When Administered Ex Vivo After Cardiopulmonary Bypass. (PubMed, Anesth Analg) - "Our results show that clots formed ex vivo with clinically relevant doses of FC (0.9 mg/mL) display similar structural and degradation characteristics compared to the in vivo transfusion of cryoprecipitate. These findings suggest that FC is effective in restoring structural fibrin clot properties after CPB. Future studies after the administration of FC in vivo are needed to validate this hypothesis."

Journal • Preclinical • Cardiovascular

PRETIC: Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. (clinicaltrials.gov) - P1/2 | N=60 | Active, not recruiting | Sponsor: Banc de Sang i Teixits | Trial completion date: Nov 2022 ➔ Mar 2023 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Hematological Disorders • Mood Disorders

Cryoprecipitate: Waste Not, Want Not (AABB 2022) - "Herein, we report our experience with introducing (PR) cryoprecipitate (INTERCEPT Fibrinogen Concentrate (IFC)) to our transfusion service, including the effect on waste and financial impact to the transfusion service... The introduction of IFC effectively decreased our wastage rate. However, PR cryoprecipitate may not be a cost saving measure based on product waste reduction alone. The increase in expenditure on IFC accounts for 6% of our total blood cost."

Hematological Disorders • Hemophilia

Comparison of fibrinogen concentrates to cryoprecipitate in restoring clot integrity and stability against fibrinolytic degradation (ISTH 2022) - "Supplementation with all fibrinogen sources (≥1 mg/ml) increased maximum absorbance in FDP clot lysis with cryoprecipitate and FibCLOT giving similar A405. Clots formed with RiaSTAP consisted of stunted fibres whereas cryoprecipitate and FibCLOT produced fibres closely representing those formed with normal plasma. Maximum clot firmness (MCF) showed a concentration dependent increase with both fibrinogen concentrates being superior to cryoprecipitate."

Hematological Disorders • Mood Disorders • Thrombosis

PRETIC: Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. (clinicaltrials.gov) - P1/2 | N=60 | Active, not recruiting | Sponsor: Banc de Sang i Teixits | Trial primary completion date: May 2022 ➔ Sep 2022

Trial primary completion date • Hematological Disorders • Mood Disorders

PRETIC: Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. (clinicaltrials.gov) - P1/2 | N=60 | Active, not recruiting | Sponsor: Banc de Sang i Teixits | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2021 ➔ Sep 2022 | Trial primary completion date: Aug 2021 ➔ May 2022

Enrollment closed • Trial completion date • Trial primary completion date • Hematological Disorders • Mood Disorders