30 closest matches · ranked by relevance
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…
Congenital Afibrinogenemia · Congenital Hypofibrinogenemia
Primary: Single-dose Pharmacokinetics (PK) of BT524: Terminal Elimination Half-life (t1/2) for Fibrinogen Antigen — 67.9 hours
Hemophilia · Factor XIII Deficiency
Primary: Response to Treatment of Bleeding Events Requiring Additional Factor XIII Infusions — 30; 1; 0; 3 Number of bleeds
Fibrinogen Deficiency
Primary: Maximum Clot Firmness (MCF) — 0; 8.9 millimeters — p=<0.0001
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…
Factor XIII Deficiency
Primary: Adverse Events — 42; 2; 2 participants
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
Congenital Heart Disease
Primary: Total Units of Intraoperative Allogenic Donor Transfusions (ADT) Administered During Procedure Through ICU Arrival. — 5; 4 ADT units
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
Post-Partum Hemorrhage
Primary: Failure Rate of PPH Management — 75; 80; 92; 92 Participants — p=0.9563
Hemostasis
Primary: Clot Degradation at 24 Hours Post-operatively — 0.65; 0.88; 0.78; 0.46 microns per hour
Factor XIII Deficiency
Primary: Peak FXIII Concentration at Steady State — 0.9 Units/mL
Hypofibrinogenemia · Afibrinogenemia · Bleeding Disorders
Primary: Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL)) — 35; 33 cc/kg
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…
Congenital Bleeding Disorder · Congenital FXIII Deficiency
Primary: Area Under the Concentration vs. Time Curve (AUC) — 250.25 IU*h/mL
Hemophilia A
Primary: Percentage of Participants Who Developed Clinically Significant Factor VIII (FVIII) Inhibitors During the Course of the Study — 21.74 Percentage of participants
Bleeding Disorder · Hypofibrinogenemia; Acquired
Primary: Intra-operative Blood Loss — 1380.7; 1660.13 mL — p=<0.001
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…
Antithrombin III Deficiency
Primary: Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT) — 0 Participants
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…
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…
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
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…
Hemophilia A
Primary: Factor VIII Inhibitor Development — 29.1 percentage
Congenital Bleeding Disorder · Congenital FXIII Deficiency
Primary: Number of Treatment Emergent (Serious and Non-serious) Adverse Events — 100; 2; 98 number of events
Hemophilia A
Primary: Percentage of Participants Who Developed Factor VIII (FVIII) Inhibitors — 0 percentage of participants
ATIII Deficiency
Primary: Difference in the Mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Time 5 (on Arrival in…
Hemophilia A
Primary: Maximum Plasma FVIII Activity (Cmax) — 1.147 IU/milliliter (mL)
Acquired Hemophilia A
Primary: Percentage of Serious Bleeding Episodes Responsive to OBI-1 — 100 percentage of serious bleeding episodes — p=<0.001
Hypofibrinogenemia · Bleeding
Primary: Total Number of RBCs Used Over Admission — 5.8; 6.7 RBC Units