Clinical trials: Afibrinogenemia
Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital
Pregnancy and Fibrinogen Disorders
The aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as…
- Conditions
- Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital, Dysfibrinogenemia, Congenital
- Trial name
- FIBRINOGEST (NCT03920332)
- Where
- 3 sites in France, Slovakia and 1 more
- Volunteers
- 149 people
- Sponsor
- University Hospital, Geneva
Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital
Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency
The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.
- Trial name
- NCT02094430
- Testing
- biological: human fibrinogen concentrate
- Where
- 4 sites in France, Lebanon and 2 more
- Volunteers
- 16 people
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Hypofibrinogenemia
A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery
This study compares the results of the existing fibrinogen concentration monitoring technology to the Electrochemical-based device, a point-of-care and rapid method,using a small amount of extra blood obtained in Type A Aortic…
- Trial name
- NCT06434389
- Testing
- the Electrochemical-based device
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Trauma Induced Coagulopathy, Trauma Coagulopathy
Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department
Background: Why This Study Matters When someone suffers a severe injury (like from a car crash), they can bleed heavily. One complication doctors often face is something called Trauma-Induced Coagulopathy (TIC).
- Conditions
- Trauma Induced Coagulopathy, Trauma Coagulopathy, Fibrinogen Deficiency, Fibrinogen; Deficiency, Acquired
- Trial name
- POCFIB (NCT07097337)
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Erasmus Medical Center
Acquired Fibrinogen Deficiency
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
This study is a phase 3, prospective, single center, randomized, open label, controlled, parallel arm, interventional study to investigate the efficacy and safety of CSL511, in participants undergoing cytoreductive surgery (CRS)…
- Trial name
- NCT06617897
- Testing
- CSL511 Fibrinogen concentrate (human), Cryoprecipitate
- Where
- United Kingdom
- Volunteers
- 90 people
- Sponsor
- CSL Behring
Fibrinogen Deficiency
Human Fibrinogen - Pharmacokinetics
This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness [MCF]) in subjects with congenital fibrinogen deficiency.
- Trial name
- NCT00496262
- Testing
- Human Fibrinogen Concentrate
- Where
- 15 sites in United States, Italy
- Volunteers
- 15 people
- Sponsor
- CSL Behring
Congenital Afibrinogenemia, Hypofibrinogenemia
FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis
This is a phase 3, multi-center, prospective, open-label, single-arm, clinical trial to be carried out in subjects with congenital fibrinogen deficiency manifested as afibrinogenemia or severe hypofibrinogenemia.
- Trial name
- NCT04636268
- Testing
- FIB Grifols
- Sponsor
- Instituto Grifols, S.A.
Congenital Afibrinogenemia, Congenital Hypofibrinogenemia
Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency
This was a prospective, open-label, multicenter, phase I/III study investigating the 14-day single-dose pharmacokinetic and pharmacodynamic properties, efficacy and safety of BT524 following intravenous administration in the…
- Trial name
- NCT02065882
- Testing
- BT524 (Part I), BT524 (Part II)
- Where
- 6 sites in Bulgaria, Egypt and 3 more
- Volunteers
- 67 people
- Sponsor
- Biotest
Severe Trauma
Predictors of Hypofibrinogenemia in Severe Trauma
In this retrospective and prospective study, the aim is to determine a score for predicting a fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of fibrinogen concentrates)
- Trial name
- NCT03020849
- Where
- 2 sites in France
- Volunteers
- 1,038 people
- Sponsor
- Hospices Civils de Lyon
Hypofibrinogenemia, Surgical Blood Loss
Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness
Fibrinogen concentrate is produced by different manufacturers using different purification technologies. The products available in Italy are three: RiaSTAP (CSL Behring), FIBRYGA (Octapharma), and FibCLOT (LFB).
- Conditions
- Hypofibrinogenemia, Surgical Blood Loss, Bleeding, Cardiac Disease
- Trial name
- EDIPORE (NCT05780125)
- Testing
- FibCLOT, RiaSTAP
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- IRCCS Policlinico S. Donato
Afibrinogenemia, Hypofibrinogenemia
Fibrinogen Concentrate (Human) - Efficacy and Safety Study
This is a multinational, multicenter, prospective, open-label historically controlled Phase IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate (Human).
- Conditions
- Afibrinogenemia, Hypofibrinogenemia, Fibrinogen Deficiency
- Trial name
- NCT00916656
- Testing
- Fibrinogen Concentrate, Human (FCH), Cryoprecipitate
- Sponsor
- CSL Behring
C.Surgical Procedure; Cardiac, Blood Coagulation Disorders
Fibrinogen Concentrate In Children Cardiac Surgery 2
The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.
- Conditions
- C.Surgical Procedure; Cardiac, Blood Coagulation Disorders, Hypofibrinogenemia
- Trial name
- FiCCS2 (NCT03884725)
- Testing
- Fibrinogen Concentrate, control
- Where
- Brazil
- Volunteers
- 42 people
- Sponsor
- Filomena R B G Galas
First Trimester Abortion, Surgical Abortion
New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT
The objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment for first-trimester…
- Conditions
- First Trimester Abortion, Surgical Abortion, Miscarriage With Afibrinogenemia
- Trial name
- NCT05360186
- Testing
- MateRegen® gel (BioRegen)
- Where
- Hong Kong
- Volunteers
- 150 people
- Sponsor
- Chinese University of Hong Kong
Trauma, Injury
Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST)
Trauma is the leading cause of death in people 44 years of age or younger. After major trauma, such as following high-speed motor vehicle collision, bleeding coupled with clotting defects is responsible for most of deaths in the…
- Conditions
- Trauma, Injury, Bleeding, Haemorrhage
- Trial name
- FiiRST (NCT02203968)
- Testing
- Fibrinogen concentrate
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Sunnybrook Health Sciences Centre
Bleeding, Cardiac Defect
ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery
In pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac surgery with extracorporeal circulation postoperative bleeding represents a known complication with a significant impact on outcome.
- Conditions
- Bleeding, Cardiac Defect, Surgery--Complications, Fibrinogenopenia; Acquired
- Trial name
- ZEPLAST-PED (NCT04434001)
- Testing
- Fibrinogen Concentrate Human, Prothrombin Complex Concentrate, Fresh Frozen Plasma
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- IRCCS Policlinico S. Donato
Anemia, Thrombocytopenia
Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence
Determine whether clinical decision support (best practice advisory) improves provider adherence to transfusion guidelines for all four major blood components (red blood cells, plasma, platelets, and cryoprecipitate) using a…
- Conditions
- Anemia, Thrombocytopenia, Coagulopathy, Mild, Hypofibrinogenemia
- Trial name
- NCT05634005
- Testing
- Clinical Decision Support
- Where
- United States
- Volunteers
- 1,543 people
- Sponsor
- University of Utah
Coagulopathy
Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions
The study aligns with the strategic plan of New York-Presbyterian Hospital (NYPH) to reduce allogeneic blood product use and decrease unnecessary laboratory costs.
- Trial name
- TOP-CLOT (NCT02540434)
- Testing
- ROTEM, Cryoprecipitate, RiaSTAP
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Weill Medical College of Cornell University
Hypofibrinogenemia, Afibrinogenemia
Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.
- Conditions
- Hypofibrinogenemia, Afibrinogenemia, Bleeding Disorders
- Trial name
- RiaSTAP (NCT02822599)
- Testing
- RiaStAP, Saline
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Trauma, Bleeding Disorder
Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized Feasibility Trial
This is a randomized feasibility trial conducted with severe trauma patients. At admission patients presented hypofibrinogenemia, hypotension and tachycardia.
- Conditions
- Trauma, Bleeding Disorder, Fibrinogen; Deficiency, Acquired
- Trial name
- NCT02864875
- Testing
- Fibrinogen concentrate
- Where
- Brazil
- Volunteers
- 32 people
- Sponsor
- University of Sao Paulo General Hospital
Congenital Afibrinogenemia
Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia
The main objective of this study was to evaluate the pharmacokinetics (PK), efficacy, and safety of human plasma-derived fibrinogen concentrate FIB Grifols after a single-dose 70 milligrams/kilogram (mg/kg) body weight…
- Trial name
- IG0902 (NCT02281500)
- Testing
- Human Plasma-Derived Fibrinogen Concentrate
- Where
- 6 sites in United States, India and 2 more
- Volunteers
- 24 people
- Sponsor
- Grifols Therapeutics LLC