Clinical trials: Hypofibrinogenemia
Insulin Growth Factor I Deficiency, IGF1 Deficiency
Effect of a HIIT Program on Quality of Life, Executive Functions, and IGF-1 Response in Sedentary Young University Women
Sedentary lifestyle, understood as an activity that requires minimal body movement (Tremblay et al., 2017), is one of the main factors responsible for chronic diseases in Young adults.
- Conditions
- Insulin Growth Factor I Deficiency, IGF1 Deficiency, Executive Function Disorder
- Trial name
- NCT05642169
- Testing
- HIIT, HIIT+PA, CON
- Where
- Spain
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- University of Seville
Fibrinogen Deficiency in Complex Cardiac Surgery
Individualized Dose of Fibrinogen Following Cardiopulmonary Bypass
Heart surgery is essential for many cardiovascular conditions, but it is a major operation with a significant mortality rate of around 4% in Europe.
- Trial name
- INDOFIB (NCT07425600)
- Testing
- Blood samples for PK
- Where
- 2 sites in France
- Volunteers
- 150 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Congenital Fibrinogen Deficiency
Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
Open-label, Uncontrolled, Multicenter Observational Study on the Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
- Trial name
- NCT03793426
- Testing
- Fibryga
- Where
- 4 sites in Czechia, Germany
- Volunteers
- 7 people
- Sponsor
- Octapharma
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
Congenital Fibrinogen Deficiency
Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency.
- Trial name
- NCT02267226
- Testing
- Octafibrin
- Where
- 12 sites in United States, Bulgaria and 7 more
- Volunteers
- 25 people
- Sponsor
- Octapharma
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
Congenital Fibrinogen Deficiency
Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency
This study will assess the efficacy of Octafibrin, a fibrinogen concentrate in in the on-demand treatment of spontaneous or traumatic bleeding episodes in paediatric patients less than 12 years of age.The planned study duration…
- Trial name
- NCT02408484
- Testing
- Octafibrin
- Where
- 4 sites in India, Iran and 1 more
- Volunteers
- 15 people
- Sponsor
- Octapharma
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
Bleeding Disorder, Hypofibrinogenemia; Acquired
Adjusted Fibrinogen Replacement Strategy
The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired…
- Trial name
- AdFIrst (NCT03444324)
- Testing
- BT524, FFP/Cryo
- Where
- 19 sites in Belgium, Czechia and 5 more
- Volunteers
- 222 people
- Sponsor
- Biotest
Hypofibrinogenemia, Hemorrhage
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex…
- Conditions
- Hypofibrinogenemia, Hemorrhage, Trauma Associated Hemorrhage, Hemorrhagic Shock
- Trial name
- CRYO-FIRST (NCT07218185)
- Testing
- Pathogen Reduced Cryoprecipitated Fibrinogen Complex
- Where
- 4 sites in United States
- Volunteers
- 320 people
- Sponsor
- Cerus Corporation
Low Fibrinogen
F-Point Validation Study
The F-Point investigation is an open label, single centre prospective observational study in 3 cohorts of patients, one with low fibrinogen concentration, one with normal fibrinogen concentration, and one with high fibrinogen…
- Trial name
- F-Point (NCT03623061)
- Testing
- F-Point
- Where
- Ireland
- Volunteers
- 150 people
- Sponsor
- Royal College of Surgeons, Ireland
Congenital Fibrinogen Deficiency, Afibrinogenemia
Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital fibrinogen deficiency
- Trial name
- NCT01575756
- Testing
- Octafibrin, Haemocomplettan® P or RiaSTAPTM
- Where
- 10 sites in United States, Bulgaria and 4 more
- Volunteers
- 22 people
- Sponsor
- Octapharma
Fibrinogen; Deficiency, Acquired, PHARMACOKINETICS
Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration
characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production.
- Trial name
- PKMF (NCT05503498)
- Testing
- DATA RECORDING
- Where
- 2 sites in Spain
- Volunteers
- 200 people
- Sponsor
- Hospital Clinic of Barcelona