blood plasma
Approved
Jun 1, 1938
Fresh frozen plasma (FFP) is a blood product made from the liquid portion of whole blood. It is used to treat conditions in which there are low blood clotting factors or low levels of other blood proteins. It may also be used as the replacement fluid in plasma exchange. Using ABO compatible plasma, while not required, may be recommended. Use as a volume expander is not recommended. It is administered by slow injection into a vein. — Wikipedia
Clinical trial activity
154 trials · 186 clinical orgs · 1 marketing orgs
Earliest trial started Mar 1, 1995 (NCT01408836)
Timeline
1930s
- Jun 1, 1938
Earliest FDA Approval
1990s
- Jan 1, 1995
Earliest Phase 2 Sponsor(trial)
2010s
- Jan 17, 2013
Octapharma — First NDA Organization
- Jan 17, 2013
Octapharma — NDA Secondary Org
- Jan 17, 2013
Octapharma — NDA Organization
Indications
Approved for
Studied for
- Acute Kidney Injury · Phase 3
- Acute-On-Chronic Liver Failure · Phase 3
- Aging · Phase 1
- Alzheimer Disease · Phase 2
- Amyotrophic Lateral Sclerosis · Early Phase 1
- Aneurysm, Ruptured · Phase 4
- Angioedema · Phase 2
- Anticoagulants · Phase 3
- Anticoagulation Reversal · Phase 2
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis · Phase 3
- Aortic Aneurysm, Thoracic · Phase 4
- Ascites · Phase 2
- Bleeding Time · Phase 4
- Blood · Phase 4
- Blood Coagulation · Phase 4
- Blood Coagulation Disorders · Phase 4
- Blood Loss, Surgical · Phase 4
- Blood Transfusion · Phase 2
- Brain Injuries, Traumatic · Phase 2/Phase 3
- Bronchiectasis · Phase 4
- Burns · Phase 4
- Cardiac Surgical Procedures · Phase 4
- Cardiovascular Surgical Procedures · Phase 4
- Cerebral Hemorrhage · Phase 2
- Chemical and Drug Induced Liver Injury · Phase 2/Phase 3
- Cognitive Dysfunction · Phase 1
- Communicable Diseases · Phase 3
- Contrast Media · Phase 3
- Coronary Artery Disease · Phase 4
- Coronavirus · Phase 2/Phase 3
- Coronavirus Infections · Phase 2/Phase 3
- COVID-19 · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 1
- Endothelial Cells · Phase 4
- Fasciitis, Plantar · Phase 4
- Fibrin · Phase 3
- Frail Elderly · Early Phase 1
- Frailty · Early Phase 1
- General Surgery · Phase 4
- Glomerulonephritis · Phase 2/Phase 3
- Glomerulonephritis, IGA · Phase 2/Phase 3
- Glomerulosclerosis, Focal Segmental · Phase 1/Phase 2
- Graft Rejection · Phase 2
- Granulomatosis with Polyangiitis · Phase 2/Phase 3
- Growth and Development · Phase 1
- Healthy Volunteers · Phase 3
- Heart Defects, Congenital · Phase 2
- Heart Diseases · Phase 3
- Heart Failure · Phase 3
- Heart Valve Diseases · Phase 4
- Hemorrhage · Phase 4
- Hemorrhagic Fever, Ebola · Phase 1
- Idiopathic Pulmonary Fibrosis · Phase 1/Phase 2
- Immunity · Phase 3
- Intracranial Hemorrhages · Phase 4
- Kidney Diseases · Phase 2/Phase 3
- Kidney Transplantation · Phase 3
- Knee Injuries · Phase 4
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 3
- Liver Cirrhosis · Phase 2
- Liver Diseases · Phase 4
- Liver Transplantation · Phase 4
- Microscopic Polyangiitis · Phase 2/Phase 3
- Minimally Invasive Surgical Procedures · Phase 3
- Multiple Sclerosis · Early Phase 1
- Osteoarthritis, Hip · Phase 4
- Osteoarthritis, Knee · Phase 2
- Pancreatic Diseases · Phase 4
- Parkinson Disease · Phase 4
- Plasma · Phase 4
- Post-Acute COVID-19 Syndrome · Phase 2
- Prostatic Neoplasms · Phase 4
- Purpura · Phase 3
- Purpura, Thrombotic Thrombocytopenic · Phase 4
- Renal Insufficiency, Chronic · Phase 3
- Respiratory Distress Syndrome · Phase 2
- Respiratory Tract Infections · Phase 3
- Scoliosis · Phase 3
- Sepsis · Phase 2
- Shock, Hemorrhagic · Phase 4
- Shock, Septic · Phase 4
- Spinal Dysraphism · Phase 4
- Sports Medicine · Phase 3
- Sprains and Strains · Phase 4
- Stroke · Phase 2
- Supranuclear Palsy, Progressive · Phase 1
- Thoracic Surgery · Phase 4
- Thrombosis · Phase 4
- Transfusion Reaction · Phase 2
- Transfusion-Related Acute Lung Injury · Phase 2
- Traumatology · Phase 4
- West Nile Fever · Phase 2
- Wounds and Injuries · Phase 4
Mechanism of action
Approval history
- approvedJun 1, 1938
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaFresh frozen plasma ↗
- NCATST74K1VTI2X ↗
- WikipediaPlasma ↗
Also known as
- blood plasma
- citrated blood plasma
- ffp
- freeze dried plasma
- fresh frozen plasma
- intercept plasma
- octaplas
- plasma
- plasma
- pooled plasma (human), solvent/detergent treated
- type ab plasma
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07212998 | Phase 3 | Apr 30, 2026 | Department of Defense, University of Pittsburgh |
| NCT07160426 | Phase 2 | Nov 1, 2025 | Harvard University, University of Colorado |
| NCT07094724 | Phase 2 | Jul 30, 2025 | Tel Aviv University |
| NCT07035509 | Phase 4 | Jul 1, 2025 | Fundación Cardioinfantil Instituto de Cardiología, University of Pittsburgh |
| NCT06934278 | Phase 3 | May 2, 2025 | University of Helsinki, University of Turku |
| NCT06837961 | Phase 3 | Apr 29, 2025 | Kyowa Kirin, RDC Clinical Pty Ltd |
| NCT06827327 | Phase 3 | Mar 28, 2025 | Kyowa Kirin, RDC Clinical Pty Ltd |
| NCT06855667 | N/A | Mar 3, 2025 | Institute of Liver and Biliary Sciences, India |
| NCT06797011 | Phase 2/Phase 3 (Phase 3) | Jan 25, 2025 | Institute of Liver and Biliary Sciences, India |
| NCT06698991 | N/A | Nov 10, 2024 | Institute of Liver and Biliary Sciences, India |
| NCT06867991 | Phase 3 | Nov 8, 2024 | The First People's Hospital of Changzhou |
| NCT06562803 | N/A | Sep 6, 2024 | Sun Yat-Sen University |
| NCT06256796 | N/A | Aug 31, 2024 | Ain Shams University |
| NCT06495294 | N/A | Aug 31, 2024 | Canadian Blood Services, Hamilton Health Sciences Corporation, Health Sciences North Research Institute, Kingston Health Sciences Centre, Queen's University, Belfast, Unity Health Toronto, University of Toronto, University of Western Ontario |
| NCT06362967 | Phase 2 | May 1, 2024 | Anhui Medical University, Anhui Province Cancer Hospital |
| NCT06642493 | N/A | May 1, 2024 | Sheikh Hasina National Institute of Burn and Plastic Surgery |
| NCT06355726 | N/A | Apr 9, 2024 | Institute of Liver and Biliary Sciences, India |
| NCT06062888 | Phase 2/Phase 3 (Phase 3) | Mar 31, 2024 | Medical College of Wisconsin, Northwestern University, Oregon Health and Science University, The University of Texas, Dallas, University of Alabama, Birmingham, University of California, Davis, University of Southern California, Vanderbilt University |
| NCT06144099 | Phase 4 | Mar 1, 2024 | Konkuk University |
| NCT06144112 | Phase 4 | Mar 1, 2024 | Konkuk University |
Organizations
Research & Development (186)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences, India | Academic/Hospital | 12 | 12 | 2 | 2016 |
| Octapharma | For profit | 9 | 5 | 4 | 2007 |
| University of Pittsburgh | Academic/Hospital | 7 | 4 | 3 | 2009 |
| CSL Behring | For profit | 5 | 2 | 2 | 2008 |
| United States Army | Government | 5 | 2 | 3 | 2014 |
| University of Copenhagen | Academic/Hospital | 5 | 4 | 4 | 1995 |
| University of Colorado, Denver | Academic/Hospital | 4 | 3 | 4 | 2012 |
| University of London | Academic/Hospital | 4 | 2 | 2 | 1995 |
| Alkahest, Inc. | For profit | 3 | 2 | 2 | 2014 |
| Department of Defense | Government | 3 | 0 | 2 | 2014 |
| Harvard University | Academic/Hospital | 3 | 2 | 2 | 2009 |
| HemCon Medical Technologies, Inc | For profit | 3 | 3 | 2 | 2010 |
| Konkuk University | Academic/Hospital | 3 | 3 | 1 | 2024 |
| Mayo Clinic | Academic/Hospital | 3 | 3 | 3 | 2006 |
| Sun Yat-Sen University | Academic/Hospital | 3 | 3 | 1 | 2019 |
| University of Cincinnati | Academic/Hospital | 3 | 1 | 1 | 2010 |
| University of Helsinki | Academic/Hospital | 3 | 1 | 2 | 1995 |
| University of Ottawa | Academic/Hospital | 3 | 3 | 3 | 2005 |
| University of Texas at Houston | Academic/Hospital | 3 | 3 | 3 | 2017 |
| University of Toronto | Academic/Hospital | 3 | 2 | 3 | 2019 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Octapharma | For profit | NDA2 | Jan 17, 2013 |
| Octapharma | For profit | NDA | Jan 17, 2013 |