Clinical trials: Fibrinogen
Congenital Heart Disease
Fibrinogen Concentrate vs Cryoprecipitate
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and…
- Trial name
- NCT03014700
- Testing
- Fibrinogen Concentrate, Cryoprecipitate
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Stanford University
Surgical Bleeding
Topical Raplixa for Surgical Bleeding in Children
The purpose of the study is to determine if Raplixa plus Gelfoam is better than Gelfoam alone in stopping mild to moderate bleeding in children having surgery.
- Trial name
- NCT02117349
- Testing
- Raplixa, Gelfoam, Rescue treatment
- Where
- 13 sites in United States
- Volunteers
- 55 people
- Sponsor
- Mallinckrodt
Pediatric HD, Bleeding
Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients
The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass (CPB)-associated bleeding in…
- Trial name
- NCT04376762
- Testing
- Fibrinogen, Cryoprecipitate
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Virginia
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, 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
Hemostasis
In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass to develop effective and safe strategies for…
- Trial name
- NCT03932240
- Testing
- Fibrinogen Concentrate (FC), Cryoprecipitate
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Emory University
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
Burn
Use of Rotational Thromboelastometry (ROTEM) to Characterize Coagulation Abnormalities in Burn Patients
This is an interventional pilot study of 40 burn inpatients. Specific aims of the proposed pilot study are to use bedside blood analysis with rotational thromboelastometry (ROTEM) in severe burn patients to provide preliminary…
- Trial name
- NCT02388776
- Testing
- ROTEM
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Weill Medical College of Cornell University
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
IUGR, Fetal Growth Retardation
Cardiac Displacement From Third Trimester to Early Childhood
The aim is to increase awareness of the relationship between (IUGR) and cardiac function in the foetus, the development of cardiac function over time after delivery and what significance a possible early disturbed myocardial…
- Conditions
- IUGR, Fetal Growth Retardation, Intrauterine Growth Restriction
- Trial name
- CADETTE (NCT02583763)
- Testing
- Echocardiography, Blood sample
- Where
- 2 sites in Sweden
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- University Hospital, Linkoeping
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
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
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
Insulin-like Growth Factor-1 Deficiency
rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency
IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in response to another hormone called growth hormone. Growth Hormone is produced by a small gland at the base of the brain (the pituitary).
- Trial name
- NCT00572156
- Testing
- NutropinAq® (Somatropin [rDNA origin]), Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Ipsen