Clinical trials: Low Fibrinogen
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
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
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
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
Hypofibrinogenemia, Bleeding
Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding
The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients.
- Trial name
- NCT05711524
- Testing
- Traditional Cryoprecipitate, Pathogen-Reduced Cryoprecipitate
- Where
- United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Growth Hormone Deficiency
Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates
Study hypothesis: Growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor (IGF)-I, can improve insulin sensitivity in adults with GH deficiency.
- Trial name
- NCT00517062
- Testing
- Growth hormone (Genotropin)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Oregon Health and Science University
Deficiency; Fibrinogen, Acquired
FIBrinogen REplenishment in Surgery
This is a pragmatic, prospective, multi-center, randomized, active-control, single-blinded, non-inferiority phase 3 trial in adult cardiac surgical patients.
- Trial name
- FIBRES (NCT03037424)
- Testing
- Octafibrin, Cryoprecipitate
- Where
- 11 sites in Canada
- Volunteers
- 827 people
- Sponsor
- University Health Network, Toronto
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
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
Trauma, Multiple
Shock Index To DEtect Low Plasma Fibrinogen In Trauma (SIDE)
Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without the need to perform other potentially time consuming investigations.
- Trial name
- SIDE (NCT02619539)
- Testing
- plasma fibrinogen measurement
- Where
- 2 sites in Czechia
- Volunteers
- 280 people
- Sponsor
- Masaryk Hospital Krajská zdravotní a.s.
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.
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
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
Hemorrhage, Coagulation Delay
Evaluation of Novel Point of Care Coagulation System in Pregnant Women
In this study the investigators will evaluate a new point of care Quantra Hemostasis Analyzer system to assess coagulation rapidly with ease.
- Trial name
- CCPW (NCT04301193)
- Testing
- Quantra Analyzer
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Myelo Dysplastic Syndrome
What is the Prognostic Value of HALP Score, Monocytopenia, Hypofibrinogenemia, and AST/ALT Ratio in Patients With Myelodysplastic Syndromes
to investigate prognostic significance of many factors in MDS including HALP score ( haemoglobin level, albumin level, lymphocyte, platelets), monocytopenia, hyperfibrinogenemia and AST/ALT ratio in patients with MDS at Assiut…
- Trial name
- NCT07210034
- Volunteers
- 100 people
- Sponsor
- Assiut University
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
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
MDS
Prognostic Value of Serum Erythropoietin Level,Ferritin Level and Fibrinogen in Adult Low Risk MDS
1. assessment of the penefit of erythropoietin administration in decreasing the frequency of blood transfusion in adult low risk MDS 2.
- Trial name
- NCT04573686
- Testing
- Erythropoietin
- Volunteers
- 50 people
- Sponsor
- Assiut University
Liver Diseases
Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery
We compared the time consumed for goal-directed management of hypofibrinogemia using two strategies during liver transplant (LT) surgery: a conventional cryoprecipitate-based strategy versus a lyophilized fibrinogen…
- Trial name
- NCT06144112
- Testing
- fresh frozen plasma, prothrombin complex concentrate
- Where
- South Korea
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Konkuk University Medical Center
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