Clinical trials: Fibrinogen
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
Coagulopathic Bleeding
Open Label Use Of RiaStap During Aortic Reconstruction
The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product…
- Trial name
- NCT01300286
- Testing
- RiaSTAP
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Duke 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
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
Dry Eye, Graft-versus-host-disease
Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease
The purpose of this Phase 1/2 study is to compare the safety and tolerability of four times a day (QID) dosing of a non-preserved topical ocular drop formulation of 10 vol/vol % and 30 vol/vol % of FD hPL to vehicle control eye…
- Conditions
- Dry Eye, Graft-versus-host-disease, Ocular Discomfort
- Trial name
- NCT03414645
- Testing
- CAM-101 10%, Vehicle Control, CAM-101 30%
- Where
- 6 sites in United States
- Volunteers
- 64 people
- Sponsor
- Cambium Bio Limited
Adenocarcinoma of the Pancreas, Metastatic Pancreatic Cancer
QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer
This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer.
- Conditions
- Adenocarcinoma of the Pancreas, Metastatic Pancreatic Cancer, Pancreatic Cancer
- Trial name
- NCT00630552
- Testing
- AMG 479, AMG 655
- Where
- 44 sites in United States
- Volunteers
- 138 people
- Sponsor
- NantCell, Inc.
Heart Valve Disease, Coronary Artery Disease
RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery
Heart surgery involving valve replacement often involves the use of the heart-lung machine for over 90 minutes, and bleeding tendency is frequently seen.
- Trial name
- RiaCT (NCT01283321)
- Testing
- Human fibrinogen concentrate, apheresis platelets
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Emory University
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
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
Acromegaly
Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly
The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment. The objective of this study was to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization…
- Trial name
- NCT00600886
- Testing
- Pasireotide, Octreotide
- Where
- 95 sites in United States, Argentina and 25 more
- Volunteers
- 358 people
- Sponsor
- Novartis Pharmaceuticals
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
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
HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma
Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-IV Breast Cancer
This phase II trial studies capecitabine and lapatinib ditosylate to see how well they work compared with capecitabine, lapatinib ditosylate, and cixutumumab in treating patients with previously treated HER2-positive stage…
- Conditions
- HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7
- Trial name
- NCT00684983
- Testing
- Capecitabine, Cixutumumab, Lapatinib Ditosylate
- Where
- 390 sites in United States
- Volunteers
- 64 people
- Sponsor
- National Cancer Institute (NCI)
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