Phase 4 N=437 Fibrinogen in Haemorrhage of Delivery
Post-Partum Hemorrhage
Primary: Failure Rate of PPH Management — 75; 80; 92; 92 Participants — p=0.9563
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 4 N=60 Fibrinogen Concentrate vs Cryoprecipitate
Congenital Heart Disease
Primary: Total Units of Intraoperative Allogenic Donor Transfusions (ADT) Administered During Procedure Through ICU Arrival. — 5; 4 ADT units
N/A N=51 Thromboelastography-derived Functional Fibrinogen Levels
Focus of Study · Coagulation Status of Cardiac Surgery Patient · Reducing Excess Blood Transfusion
Primary: Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV) — -1.1 mg/dL
Phase 2 N=15 Human Fibrinogen - Pharmacokinetics
Fibrinogen Deficiency
Primary: Maximum Clot Firmness (MCF) — 0; 8.9 millimeters — p=<0.0001
Phase 2 N=22 Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia
Congenital Afibrinogenemia
Primary: Area Under the Plasma Fibrinogen Concentration-time Curve (AUC) From Time Zero to 14 Days (AUC0-14days) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70…
Phase 3 N=222 Adjusted Fibrinogen Replacement Strategy
Bleeding Disorder · Hypofibrinogenemia; Acquired
Primary: Intra-operative Blood Loss — 1380.7; 1660.13 mL — p=<0.001
Phase 4 N=30 Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
Hypofibrinogenemia · Afibrinogenemia · Bleeding Disorders
Primary: Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL)) — 35; 33 cc/kg
Phase 3 N=62 Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery
Cardiac Complication During Procedure
Primary: Cumulative Transfusion Units — 0; 0 Transfusion Units — p=.908
N/A N=72 Clinical Trial of Factor XIII (FXIII) Concentrate
Hemophilia · Factor XIII Deficiency
Primary: Response to Treatment of Bleeding Events Requiring Additional Factor XIII Infusions — 30; 1; 0; 3 Number of bleeds
Phase 4 N=20 Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding
Hypofibrinogenemia · Bleeding
Primary: Total Number of RBCs Used Over Admission — 5.8; 6.7 RBC Units
Phase 3 N=36 In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
Hemostasis
Primary: Clot Degradation at 24 Hours Post-operatively — 0.65; 0.88; 0.78; 0.46 microns per hour
Phase 3 N=35 Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency
Congenital Afibrinogenemia · Congenital Hypofibrinogenemia
Primary: Single-dose Pharmacokinetics (PK) of BT524: Terminal Elimination Half-life (t1/2) for Fibrinogen Antigen — 67.9 hours
Phase 3 N=9 A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia
Hypoplasminogenemia · Congenital Plasminogen Deficiency
Primary: Overall Clinical Success in Number and Size of Lesions as Measured by Photographic or Other Imaging Modality Depending on the Organ System Affected or Change in Affected…
Phase 4 N=31 Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients
Pediatric HD · Bleeding
Primary: A Composite of the Number of Any Allogeneic Blood Products (RBCs, Plasma, Platelets, Cryoprecipitate) Transfused From Administration of the Study Medication Until 48…
Phase 3 N=25 Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
Congenital Fibrinogen Deficiency
Primary: Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient. — 19; 23; 5; 1 Participants
Phase 2 N=22 Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
Congenital Fibrinogen Deficiency · Afibrinogenemia
Primary: Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized — 1.196 ratio
Phase 3 N=61 An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
Factor XIII Deficiency
Primary: Adverse Events — 42; 2; 2 participants
Phase 3 N=41 A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
Factor XIII Deficiency
Primary: The Incidence of Spontaneous Bleeding Events Requiring Treatment (Treatment is Defined as Administration of a FXIII-Containing Product to Treat the Bleeding Event) — 0…
Phase 2 N=15 A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency
Factor XIII Deficiency
Primary: Peak FXIII Concentration at Steady State — 0.9 Units/mL
Phase 3 N=15 Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency
Congenital Fibrinogen Deficiency
Primary: Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in the On-demand Treatment of the First Documented Bleeding Episode of Each Patient Based on a…
Phase 4 N=40 Fibrinolysis Before Cardiopulmonary Bypass?
Pathologic Fibrinolysis
Primary: Di-Dimer Increase Before Cardiopulmonary Bypass — 317; 266; 317; 291 ng/mL
N/A N=24 Coagulation Factor Changes Associated With Postpartum Hysterectomies
Obstetric Labor Complications · Hemorrhage · Complications; Cesarean Section
Primary: Fibrinogen Level at 2 Hours After Delivery — 186; 418 mg/dL — p=<0.05
Early Phase 1 N=20 Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4
Type 2 Diabetes
Primary: Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound on Day 2 — 2; 7 percentage of change
Phase 3 N=41 Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency
Congenital Bleeding Disorder · Congenital FXIII Deficiency
Primary: Rate (Number Per Subject Year) of Bleeding Episodes Requiring Treatment With a FXIII Containing Product During the Treatment Period — 0.138 bleeding episodes per subject…
N/A N=480 Maternal Lifestyle and Neonatal Hypoglycemia
Hyperinsulinemia · Miscarriages · Pregnancy
Primary: Neonatal Hypoglycemia — 3; 15 neonates
Phase 3 N=465 Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care
COVID-19
Primary: Composite Outcome of ICU Admission, Non-invasive Positive Pressure Ventilation, Invasive Mechanical Ventilation, or All-cause Death up to 28 Days. — 37; 52 Participants
Phase 2 N=23 Rituximab to Treat Severe Hemophilia A
Hemophilia A
Primary: Proportion of Subjects With Major Response, i.e. Inhibitor Level Falls to Less Than 5 BU/mL Between Weeks 6 to 22 and Remains Below 5 BU/mL at 5-7 Days Following…
Phase 4 N=23 Open Label Use Of RiaStap During Aortic Reconstruction
Coagulopathic Bleeding
Primary: Fibrinogen Level Change — 317; 235; 331; 312 mg/dl
Phase 3 N=6 Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency
Congenital Bleeding Disorder · Congenital FXIII Deficiency
Primary: Area Under the Concentration vs. Time Curve (AUC) — 250.25 IU*h/mL
Phase 3 N=16 Prospective Biomarkers of Bone Metabolism in Hemophilia A
Hemophilia · Bone Disease
Primary: Bone Biomarker Density (BMD) — -0.74; -0.16; -0.16 Z-Score