Fibrinogen Concentrate Human
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | TachoSil | — | 2004-06-08 | europa.eu ↗ |
Trials 86 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04664738 | Mar 2021 → Aug 2023 | — | Rion Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT02584153 | Jan → Dec 2019 | — | Hobart Harris | Withdrawn | No outcome recorded |
| Phase 1 | NCT00155402 | Apr 2005 → Mar 2008 | corneal ulcer, pterygium | National Taiwan University Hospital | Withdrawn | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT02528708 | Jan → Dec 2021 | — | Yale University | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03780894 | Nov 2018 → Jan 2021 | — | Blood and Tissue Bank of Catalonia | Completed | No outcome recorded |
| Phase 1/2 | NCT03304899 | Oct 2018 → Dec 2019 | hemorrhagic disease, traumatic brain injury | Leila Dehghani | Unknown | No outcome recorded |
| Phase 1/2 | NCT02281500 | Jul 2016 → Nov 2019 | congenital afibrinogenemia | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT00161759 | Mar 2002 → Jan 2004 | — | Baxter Healthcare Corporation | Completed | No outcome recorded |
| Phase 215 trials | ||||||
| Phase 2 | NCT05091684 | Feb 2022 → May 2023 | blood platelet disease, hemorrhagic disease | University Hospital of Saint-Etienne | Terminated | No outcome recorded |
| Phase 2 | NCT04434001 | Feb 2020 → May 2021 | acquired coagulation factor deficiency, acute lung injury, congenital heart disease, hemorrhagic disease | IRCCS Policlinico S. Donato | Terminated | No outcome recorded |
| Phase 2 | NCT03508141 | Jul 2018 → Jun 2021 | blood coagulation disease, hemorrhagic disease | Gold Coast Hospital and Health Service | Unknown | No outcome recorded |
| Phase 2 | NCT04807621 | Mar 2018 → Jan 2022 | congenital heart disease | Sahlgrenska University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02745041 | Dec 2016 → Jan 2018 | blood coagulation disease, hemorrhagic disease | Gold Coast Hospital and Health Service | Completed | No outcome recorded |
| Phase 2 | NCT02117349 | Dec 2014 → Nov 2017 | — | Mallinckrodt | Terminated | No outcome recorded |
| Phase 2 | NCT02542306 | Jul 2013 → Aug 2016 | aortic disorder | Hongjia Zhang | Unknown | No outcome recorded |
| Phase 2 | NCT01575756 | Jun 2013 → Jan 2015 | congenital afibrinogenemia | Octapharma | Completed | No outcome recorded |
| Phase 2 | NCT01589822 | Jun 2012 → Jan 2014 | digestive system disorder | Ethicon, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01283321 | Jan 2011 → May 2013 | coronary artery disorder, heart valve disorder | Emory University | Terminated | No outcome recorded |
| Phase 2 | NCT01256190 | Dec 2010 → Sep 2011 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 2 | NCT01244425 | Nov 2010 → Jul 2011 | — | Baxter Healthcare Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00968045 | Apr 2009 → Feb 2012 | coronary artery disorder, hemorrhagic disease | Sahlgrenska University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00658723 | Mar 2008 → Apr 2009 | vascular hemostatic disease | Ethicon, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00496262 | Jul 2007 → May 2008 | congenital fibrinogen deficiency | CSL Behring | Completed | No outcome recorded |
| Phase 2/36 trials | ||||||
| Phase 2/3 | NCT05358977 | May 2022 → May 2023 | eyelid disorder, ptosis | University of Calgary | Unknown | No outcome recorded |
| Phase 2/3 | NCT04621799 | Jun 2018 → Dec 2020 | lumbar disk degenerative disorder, lumbar disk disease, radiculopathy | Pauza, Kevin, MD | Unknown | No outcome recorded |
| Phase 2/3 | NCT02094430 | Jan 2014 → Dec 2015 | congenital afibrinogenemia | LFB | Completed | No outcome recorded |
| Phase 2/3 | NCT01359878 | May 2011 → May 2013 | — | Copenhagen University Hospital at Herlev | Completed | No outcome recorded |
| Phase 2/3 | NCT01124981 | Feb 2011 → Dec 2014 | coagulation protein disease | Isala | Completed | No outcome recorded |
| Phase 2/3 | NCT01174992 | Jul 2010 → Sep 2011 | craniofacial and skeletal defects | Ethicon, Inc. | Completed | No outcome recorded |
| Phase 325 trials | ||||||
| Phase 3 | NCT04636268 | Dec 2023 → Mar 2025 | congenital afibrinogenemia | Grifols, S.A. | Withdrawn | No outcome recorded |
| Phase 3 | NCT05449834 | Nov 2022 → Jun 2026 overdue | blood coagulation disease | Australian and New Zealand Intensive Care Research Centre | Recruiting | No outcome recorded |
| Phase 3 | NCT05300672 | Feb 2022 → Dec 2024 | intracerebral hemorrhage, ischemic stroke | Azienda Usl di Bologna | Completed | No outcome recorded |
| Phase 3 | NCT03932240 | Aug 2019 → Apr 2021 | vascular hemostatic disease | Emory University | Completed | No outcome recorded |
| Phase 3 | NCT04111822 | Oct 2018 → Oct 2020 | infectious disease with sepsis | Cristina Martinez | Completed | No outcome recorded |
| Phase 3 | NCT03444324 | Apr 2018 → Sep 2023 | coagulation protein disease | Biotest | Completed | No outcome recorded |
| Phase 3 | NCT02457546 | Jul 2015 → Sep 2017 | cerebrospinal fluid leak | Ethicon, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02284256 | Nov 2014 → Aug 2015 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 3 | NCT02309645 | Oct 2014 → Aug 2021 | cerebrospinal fluid leak | Ethicon, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02227706 | Aug 2014 → Apr 2019 | hemorrhagic disease | Ethicon, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01613664 | Feb 2014 → May 2018 | morbid obesity | Centre Hospitalier Universitaire, Amiens | Completed | No outcome recorded |
| Phase 3 | NCT02065882 | Mar 2013 → May 2020 | congenital afibrinogenemia | Biotest | Completed | No outcome recorded |
| Phase 3 | NCT02153593 | Mar 2013 → Mar 2015 | bone neoplasm | Sant Pau Research Institute | Terminated | No outcome recorded |
| Phase 3 | NCT02150720 | Feb 2013 → Apr 2015 | — | Sant Pau Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT01662856 | Aug 2012 → Dec 2015 | vascular hemostatic disease | Grifols, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT01539057 | Jul 2012 → Sep 2013 | esophageal varices with bleeding | Hospital Universitari de Bellvitge | Unknown | No outcome recorded |
| Phase 3 | NCT01527357 | May 2012 → Apr 2013 | — | Mallinckrodt | Completed | No outcome recorded |
| Phase 3 | NCT01475669 | Jan 2012 → Jul 2014 | — | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT01306370 | Jun 2010 → Oct 2011 | arthropathy | Sant Pau Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT01011816 | Mar 2010 → Dec 2012 | chronic pain syndrome, lumbar disk degenerative disorder | Spinal Restoration, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00916656 | Oct 2009 → Mar 2014 | congenital afibrinogenemia | CSL Behring | Withdrawn | No outcome recorded |
| Phase 3 | NCT00365248 | Oct 2005 → May 2008 | liver disorder | Nycomed | Completed | No outcome recorded |
| Phase 3 | NCT00154141 | Jun 2005 → Mar 2006 | peripheral vascular disease | Ethicon, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00028951 | Jan 2003 → Dec 2005 | lymphedema, vulva cancer | Gynecologic Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00161915 | Dec 2000 → Jan 2004 | esophageal varices | Baxter Healthcare Corporation | Completed | No outcome recorded |
| Phase 419 trials | ||||||
| Phase 4 | NCT07455591 | Jan → Aug 2024 | osteoarthritis, knee | Singapore General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05391412 | Jun 2022 → Jul 2023 | disseminated intravascular coagulation, hemorrhagic disease, scoliosis | Brno University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04376762 | Oct 2021 → Mar 2023 | hemorrhagic disease, juvenile Huntington disease | University of Virginia | Completed | No outcome recorded |
| Phase 4 | NCT02953145 | Sep 2019 → Sep 2020 | cleft palate | University of Alberta | Withdrawn | No outcome recorded |
| Phase 4 | NCT04405518 | Jun 2019 → Nov 2021 | fibrinolytic defect | Antoni Sabaté Pes | Unknown | No outcome recorded |
| Phase 4 | NCT03920306 | Apr 2019 → Sep 2024 | gastrocutaneous syndrome | University of British Columbia | Completed | No outcome recorded |
| Phase 4 | NCT03183479 | Jun 2017 → Aug 2019 | adolescent idiopathic scoliosis, hemorrhagic disease | Peking Union Medical College Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02864875 | Dec 2015 → Jan 2017 | acquired coagulation factor deficiency | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02299947 | Aug 2014 → Apr 2018 | hemorrhagic disease, thoracic aortic aneurysm | St. Antonius Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT02155725 | Apr 2014 → Aug 2018 | — | LFB | Completed | No outcome recorded |
| Phase 4 | NCT01910675 | Jul 2013 → Oct 2018 | — | Helsinki University Central Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT01955811 | Dec 2012 → Aug 2014 | — | Medical University Innsbruck | Completed | No outcome recorded |
| Phase 4 | NCT01538927 | Apr → Dec 2012 | periodontitis | Chhattisgarh Dental College and Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT01487837 | Jan 2012 → Oct 2014 | blood coagulation disease, hemorrhagic disease | University Children's Hospital, Zurich | Completed | No outcome recorded |
| Phase 4 | NCT01300286 | Dec 2010 → Dec 2012 | hemorrhagic disease | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT00994045 | Jun 2010 → Aug 2013 | — | University of Edinburgh | Completed | No outcome recorded |
| Phase 4 | NCT00775034 | Jan 2010 → Oct 2014 | — | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT00290836 | May 2004 → Aug 2007 | — | Nycomed | Completed | No outcome recorded |
| Phase 4 | NCT00324272 | Jan 2003 → Dec 2006 | melanoma, squamous cell carcinoma | Oxford University Hospitals NHS Trust | Completed | No outcome recorded |
| Phase not applicable13 trials | ||||||
| — | NCT06582420 | Jan → Aug 2025 overdue | — | Unidade Local de Saude do Arco Ribeirinho | Not yet recruiting | No outcome recorded |
| — | NCT05490940 | Mar 2023 → Dec 2025 | peripheral nerve lesion | Insel Gruppe AG, University Hospital Bern | Unknown | No outcome recorded |
| — | NCT04602689 | Oct 2020 → Jul 2022 | gastric adenoma, gastric carcinoma | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT03784794 | Nov 2018 → Nov 2020 | acquired coagulation factor deficiency, hemorrhagic disease | Angel Augusto Perez Calatayud | Completed | No outcome recorded |
| — | NCT03801135 | Oct 2018 → Sep 2019 | Guillain-Barre syndrome, Miller Fisher syndrome, anti-glomerular basement membrane disease, chronic inflammatory demyelinating polyradiculoneuropathy +2 | University Medical Centre Ljubljana | Unknown | No outcome recorded |
| — | NCT01816282 | Mar 2011 → Apr 2012 | osteoarthritis, knee | University of Milan | Completed | No outcome recorded |
| — | NCT01649505 | Jan 2011 → Jan 2012 | breast cancer | OHSU Knight Cancer Institute | Terminated | No outcome recorded |
| — | NCT01226914 | Jun 2010 → Jul 2014 | goiter, thyroid tumor | Medical University of South Carolina | Completed | No outcome recorded |
| — | NCT00440921 | Dec 2008 → Dec 2009 | osteoarthritis, knee | Sanquin Research & Blood Bank Divisions | Withdrawn | No outcome recorded |
| — | NCT00713596 | Jul 2008 → Jan 2010 | — | Mayo Clinic | Terminated | No outcome recorded |
| — | NCT00506311 | Feb 2003 → Dec 2007 | melanoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| — | NCT00504582 | May 2002 → Apr 2020 | melanoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| — | NCT00181974 | Mar 2000 → Feb 2007 | — | Massachusetts General Hospital | Completed | No outcome recorded |
Also used as a comparator or background therapy in 39 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05553132 Background | Aug 2023 → Dec 2026 expected | cartilage development disorder | Daniel B. F. Saris | Active not recruiting | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06793748 Comparator | Jun → Nov 2025 overdue | chronic ulcer of skin | Rion Inc. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT02203968 Comparator | Oct 2014 → Dec 2015 | blood coagulation disease, hemorrhagic disease | Sunnybrook Health Sciences Centre | Completed | No outcome recorded |
| Phase 1/2 | NCT01475344 Comparator | Sep 2011 → Oct 2015 | — | Medical University Innsbruck | Completed | No outcome recorded |
| Phase 1/2 | NCT00493272 Comparator | Jun 2007 → Apr 2008 | blood coagulation disease | Christian Fenger-Eriksen | Completed | No outcome recorded |
| Phase 213 trials | ||||||
| Phase 2 | NCT06319287 Comparator | Feb 2024 → Apr 2025 | ulcer of lower limbs | Rion Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05780125 Comparator | Mar 2023 → Feb 2024 | coagulation protein disease, heart disorder, hemorrhagic disease | IRCCS Policlinico S. Donato | Completed | No outcome recorded |
| Phase 2 | NCT05264922 Background | Jan → Jul 2022 | rotator cuff syndrome | AdventHealth | Withdrawn | No outcome recorded |
| Phase 2 | NCT06840561 Background | Nov 2021 → Dec 2024 | esophageal cancer | Sun Yat-sen University Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03449082 Background | Mar 2018 → Jul 2019 | epicondylitis | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03276975 Comparator | Dec 2017 → Mar 2020 | cerebrospinal fluid leak | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT02343263 Comparator | Mar 2015 → May 2017 | neuropathy, painful | Indiana University | Terminated | No outcome recorded |
| Phase 2 | NCT02344069 Comparator | Feb 2015 → Mar 2017 | hemorrhagic disease | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 2 | NCT02298023 Comparator | Sep 2014 → Jul 2016 | rotator cuff syndrome | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01681030 Comparator | Aug 2012 → Aug 2013 | cardiovascular disorder | Ethicon, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01187225 Comparator | Aug 2010 → Jan 2011 | blood coagulation disease | University of Sao Paulo | Completed | No outcome recorded |
| Phase 2 | NCT02545153 Comparator | Jan 2009 → Jan 2016 | choledocholithiasis, infectious disease | Enköping Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT00701142 Comparator | Jun 2008 → Mar 2010 | aortic aneurysm | CSL Behring | Completed | No outcome recorded |
| Phase 311 trials | ||||||
| Phase 3 | NCT04612465 Comparator | Jan 2020 → Apr 2025 overdue | intestinal fistula | Anterogen Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03461406 Comparator | Jan 2019 → Apr 2022 | — | Grifols, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT04149171 Comparator | Sep 2018 → Dec 2020 | — | Cristina Martinez | Completed | No outcome recorded |
| Phase 3 | NCT02553122 Comparator | Oct 2015 → Oct 2016 | osteoarthritis, knee | Montefiore Medical Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT01623531 Comparator | Feb 2014 → Mar 2019 | cardiac valvular defect | Nova Scotia Health Authority | Completed | No outcome recorded |
| Phase 3 | NCT02040428 Comparator | Jan 2014 → Jul 2015 | cardiovascular disorder | Ethicon, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01803347 Comparator | Feb 2013 → Oct 2017 | anal fistula | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Completed | No outcome recorded |
| Phase 3 | NCT01545635 Comparator | Mar 2012 → Feb 2016 | brain injury | Medical University Innsbruck | Terminated | No outcome recorded |
| Phase 3 | NCT01471730 Comparator | Nov 2011 → Dec 2014 | heart disorder | IRCCS Policlinico S. Donato | Completed | No outcome recorded |
| Phase 3 | NCT01631448 Comparator | May 2010 → Jan 2014 | lymphocele, urinary tract obstruction, vascular insufficiency disorder | Alejandro Gonzalez-Ojeda | Completed | No outcome recorded |
| Phase 3 | NCT01126060 Comparator | Feb 2010 → Jan 2011 | thyroid gland carcinoma | Samsung Medical Center | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT03733639 Comparator | Jul 2020 → Jul 2021 | gastric cancer, intestinal perforation | Germans Trias i Pujol Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03884725 Comparator | Mar → Jun 2019 | coagulation protein disease | Filomena R B G Galas | Unknown | No outcome recorded |
| Phase 4 | NCT03310060 Comparator | Nov 2017 → Aug 2018 | — | Chang Gung Memorial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02822599 Comparator | Jun 2017 → Aug 2019 | coagulation protein disease, hemorrhagic disease | Nicklaus Children's Hospital f/k/a Miami Children's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03014700 Comparator | Mar 2016 → Apr 2018 | congenital heart disease | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT01235715 Comparator | Sep 2010 → Mar 2012 | osteoarthritis | Hospital for Special Surgery, New York | Completed | No outcome recorded |
| Phase 4 | NCT01472913 Comparator | Aug 2010 → Aug 2013 | — | Hvidovre University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01306851 Comparator | Jun 2007 → Mar 2013 | intestinal perforation | Hospital General Universitario Gregorio Marañon | Unknown | No outcome recorded |
| Phase 4 | NCT00440401 Comparator | Feb → Aug 2007 | vascular hemostatic disease | Nycomed | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02540434 Comparator | Oct 2015 → Jul 2016 | blood coagulation disease | Weill Medical College of Cornell University | Terminated | No outcome recorded |
Press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-02-01 | Takeda | Takeda Completes Sale of TachoSil ® to Corza Health takeda.com ↗ |
| 2020-09-16 | Takeda | Takeda to Divest TachoSil ® to Corza Health for €350 Million takeda.com ↗ |
| 2016-04-27 | Takeda | European Commission Approves Surgical Patch TachoSil ® (human thrombin/human fibrogen) for Use in Neurological Surgery takeda.com ↗ |
| 2014-09-16 | CSL Behring | CSL Behring Announces Last Patient Treated in Phase III Study of Fibrinogen Concentrate to Control Bleeding During Aortic Aneurysm Surgery csl.com ↗ |
| 2012-12-19 | CSL Behring | Phase II Study Indicates that Fibrinogen Concentrate Given as a First-Line Therapy Safely Reduces Need for Transfusion after Aortic Surgery csl.com ↗ |
| 2012-03-15 | CSL Behring | CSL Behring Announces First Patient Treated in Phase III Study of Fibrinogen Concentrate (Human)(FCH) to Control Bleeding During Aortic Aneurysm Surgery csl.com ↗ |
| 2009-03-11 | CSL Behring | CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP csl.com ↗ |
| 2009-01-16 | CSL Behring | CSL Behring Receives FDA Approval of RiaSTAP, First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency csl.com ↗ |
Evidence & citations 35 cited values
Every value below carries the sentence it was read from. 127 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fibrinogen Concentrate (Human) | “OBJECTIVES: To assess the pharmacokinetic (PK) profile, clot integrity and safety of fibrinogen concentrate (human) (FCH) in patients with afibrinogenemia.” PMID 19804533 ↗ Oct 20098“RiaSTAP, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes.” NCT03304899 ↗ |
| Known as | BIOSTAT BIOLOGX | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01011816 ↗ |
| Known as | BT524 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02065882 ↗ |
| Known as | EVARREST | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01681030 ↗ |
| Known as | EVARREST Fibrin Sealant Patch | “EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components...” NCT01681030 ↗ |
| Known as | EVICEL | “This study evaluated the safety and haemostatic effectiveness of a fibrin sealant (EVICEL(™) Fibrin Sealant (Human)) during vascular surgery.” PMID 20730858 ↗ Aug 2010 |
| Known as | EVICEL Fibrin Sealant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01589822 ↗ |
| Known as | FCH | “OBJECTIVES: To assess the pharmacokinetic (PK) profile, clot integrity and safety of fibrinogen concentrate (human) (FCH) in patients with afibrinogenemia.” PMID 19804533 ↗ Oct 20092“Single-dose human fibrinogen concentrate (FCH) was associated with the transfusion of increased allogeneic blood products (ABPs) versus placebo.” PMID 30462259 ↗ Apr 2019 “Fibrinogen Concentrate, Human (FCH)” NCT00916656 ↗ |
| Known as | FGTW | “Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency” NCT02094430 ↗1“Fibrinogen (FGTW)” NCT01955811 ↗ |
| Known as | FIB Grifols | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04636268 ↗ |
| Known as | Fibrin adhesive | “•Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive” NCT01803347 ↗ |
| Known as | Fibrin glue | “2. A topical adhesive of either 2-Octylcyanoacrylate glue (Dermabond), or Fibrin glue, or Histoacryl glue (Tissue Seal), will be applied over the fistula's aperture.” NCT03920306 ↗ |
| Known as | Fibrin Sealant | “Fibrin Sealant (Tisseel) used in the Experimental Arm.” NCT00324272 ↗ |
| Known as | fibrinogen | “Combination of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).” NCT01662856 ↗15“single dose fibrinogen concentrate immediately after CTC leads to a decrease in the number of allogenic blood transfusions” NCT02299947 ↗ |
| Known as | Fibrinogen concentrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02155725 ↗ |
| Known as | Fibrinogen human | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00365248 ↗ |
| Known as | Fibrocaps | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01527357 ↗ |
| Known as | Haemocomplettan P | “Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with...” NCT01187225 ↗4“Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump.” NCT03884725 ↗ |
| Known as | Human Fibrinogen | “Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen...” NCT00658723 ↗4“These samples will be spiked with Human Fibrinogen and clotting tests will be performed.” NCT01955811 ↗ “Equine collagen with Human Fibrinogen and Human Thrombin” NCT01681030 ↗ “Equine collagen with Human Fibrinogen and Human Thrombin” NCT02040428 ↗ |
| Known as | Human Fibrinogen concentrate | “Drug: Human Fibrinogen concentrate” NCT02155725 ↗5“Drug: Human Fibrinogen Concentrate” NCT01475344 ↗ |
| Known as | Porcine fibrin sealant kit | “The operator checked the wound to make sure there was no bleeding or perforation after the TA injection, then sprayed 5-10ml fibrin glue (Porcine fibrin sealant kit, China) on...” NCT06840561 ↗ |
| Known as | PRO-0601 | “Other Names: * Raplixa * PRO-0601 * Fibrin sealant” NCT02284256 ↗ |
| Known as | Raplixa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02117349 ↗ |
| Known as | Riastap | “The drug used in this study is Riastap, 1g (Fibrinogen).” NCT04405518 ↗7“Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]” NCT03780894 ↗ |
| Known as | RiaSTAPTM | “Commercially available Haemocomplettan® P or RiaSTAPTM (same product with different names in different markets) were supplied as powders for reconstitution with water for injection.” NCT01575756 ↗ |
| Known as | TachoSil | “Fibrinogen human (TachoSil)” NCT00365248 ↗ |
| Known as | Tisseel | “In the arm "Tisseel®" surgeon dispenses the product all over the anastomosis.” NCT03733639 ↗17“TISSEEL® fibrin sealant (Baxter Biosurgery, Deerfield, IL)” NCT02584153 ↗ “Tisseel applied externally to the dissected axillary area.” NCT00504582 ↗ |
| Known as | Tisseel Injectable Product | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05264922 ↗ |
| Known as | TISSEEL VH | “A Phase III Clinical Trial Use of TISSEEL VH Fibrin Sealant to Reduce Lymphedema Incidence After Inguinal Lymph Node Dissection Performed in the Management of Vulvar Malignancies” NCT00028951 ↗ |
| Known as | TISSEEL VH SD Kit | “Fibrin Sealant (TISSEEL® VH SD Kit)” NCT06793748 ↗ |
| Known as | tissue fibrin glue | “tissue fibrin glue application (Tisseel)” NCT00155402 ↗ |
| Known as | VeraSeal | “This study is conducted as a pilot trial to assess the added benefit of the VeraSeal fibrin sealant to TXA on postoperative outcomes following TKR.” NCT07455591 ↗ |
| Action | Restore | “Together with the clot integrity and safety data and published data on efficacy, the results support the idea that FCH substitution can restore hemostasis with a good safety profile.” PMID 19804533 ↗ Oct 2009 |
| Modality | Protein / enzyme biologic | “Fibrin sealant is produced from human fibrinogen and human thrombin from pooled plasma” NCT00181974 ↗ |
| Route | Other | “VH fibrin sealant sprayed into the groin followed by sutured closure (FS).” PMID 18482765 ↗ May 2008 |