Drugs / Fresh Frozen Plasma
last change 11 days ago re-read 9 days ago

Fresh Frozen Plasma

also known as FFP · Blood plasma · Human Plasma

Protein / enzyme biologic

Developed for
B-cell chronic lymphocytic leukemia · blood coagulation disease · intracerebral hemorrhage · chronic liver failure · chronic lymphocytic leukemia/small lymphocytic lymphoma · cirrhosis of liver · COVID-19 · dengue shock syndrome
+10 more · hemorrhagic disease · idiopathic nephrotic syndrome · infectious disease with sepsis · liver disorder · progressive supranuclear palsy · traumatic brain injury · brain injury · cardiac valvular defect · coagulation protein disease · thoracic aortic aneurysm
Investigated by
Beijing Chao Yang Hospital · Beth Israel Deaconess Medical Center · Children's Hospital and Institute of Child Health, Multan · Duke University · Enos Bernasconi · GlaxoSmithKline
+28 more · Heidelberg University · HemCon Medical Technologies, Inc · Institute of Liver and Biliary Sciences, India · Johns Hopkins University · Joseph Tuscano · Mayo Clinic · Medical College of Wisconsin · Montefiore Medical Center · National Cancer Institute, Egypt · National Heart, Lung, and Blood Institute (NHLBI) · Northwestern University · Oregon Health and Science University · Qamar Shafiq · Rutgers, The State University of New Jersey · Sheikh Hasina National Institute of Burn and Plastic Surgery · The First Affiliated Hospital with Nanjing Medical University · University Of Perugia · University of Alabama at Birmingham · University of California, Davis · University of California, San Francisco · University of Colorado Health · University of Colorado, Denver · University of Pittsburgh · University of Southern California · University of Texas Southwestern Medical Center · University of Washington · Vanderbilt University Medical Center · Wolfson Medical Center

Trials 20

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT02460731 May 2015 → Dec 2017 progressive supranuclear palsy University of California, San Francisco Completed No outcome recorded
Phase 1 NCT00968487 Jun 2010 → Dec 2011 — HemCon Medical Technologies, Inc Completed No outcome recorded
Phase 24 trials
Phase 2 NCT07160426 Jul 2026 → Jun 2028 expected infectious disease with sepsis Beth Israel Deaconess Medical Center Not yet recruiting No outcome recorded
Phase 2 NCT01716208 Jan 2013 → Oct 2019 B-cell chronic lymphocytic leukemia Joseph Tuscano Completed No outcome recorded
Phase 2 NCT00892827 Apr → Jul 2009 B-cell chronic lymphocytic leukemia Wolfson Medical Center Unknown No outcome recorded
Phase 2 NCT00222625 Sep 2005 → Sep 2006 intracerebral hemorrhage University Of Perugia Unknown No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06062888 Feb 2026 → Aug 2028 expected traumatic brain injury Northwestern University Recruiting No outcome recorded
Phase 33 trials
Phase 3 NCT02637427 Feb 2016 → Jun 2019 blood coagulation disease, hemorrhagic disease Rutgers, The State University of New Jersey Completed No outcome recorded
Phase 3 NCT01670812 Jan 2012 → Jun 2013 chronic lymphocytic leukemia/small lymphocytic lymphoma The First Affiliated Hospital with Nanjing Medical University Unknown No outcome recorded
Phase 3 NCT00953901 Jul 2006 → Dec 2007 blood coagulation disease Mayo Clinic Completed No outcome recorded
Phase 43 trials
Phase 4 NCT03202524 Dec 2017 → Jul 2018 cirrhosis of liver Montefiore Medical Center Withdrawn No outcome recorded
Phase 4 NCT02366845 Jun 2012 → Jun 2015 liver disorder University of Colorado, Denver Completed No outcome recorded
Phase 4 NCT00928915 Jul 2009 → Jan 2015 intracerebral hemorrhage Heidelberg University Completed No outcome recorded
Phase not applicable7 trials · 1 missed
— NCT07685093 Jul → Oct 2026 expected idiopathic nephrotic syndrome Qamar Shafiq Not yet recruiting No outcome recorded
— NCT06642493 May → Dec 2024 overdue dengue shock syndrome Sheikh Hasina National Institute of Burn and Plastic Surgery Active not recruiting No outcome recorded
— NCT04107883 Oct 2023 → Dec 2024 chronic liver failure Beijing Chao Yang Hospital Unknown No outcome recorded
— NCT04683614 Oct 2020 → May 2022 — National Cancer Institute, Egypt Completed No outcome recorded
— NCT04365439 Jul → Dec 2020 COVID-19 Enos Bernasconi Unknown No outcome recorded
— NCT02689232 Feb 2016 → Mar 2018 — Institute of Liver and Biliary Sciences, India Completed No outcome recorded
— NCT01903863 Jul 2013 → Feb 2016 — Duke University Completed Missed primary
Comparator or background therapy24 trials
Phase 1 NCT02930226 Comparator Feb 2017 → Aug 2018 — U.S. Army Medical Research and Development Command Completed No outcome recorded
Phase 1 NCT00770718 Comparator Apr 2008 → Apr 2010 intracerebral hemorrhage University of Utah Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT04794348 Comparator May 2021 → Mar 2022 — Teleflex Withdrawn No outcome recorded
Phase 2 NCT04374539 Background Apr 2020 → Jun 2021 COVID-19 Fundacion Clinic per a la Recerca Biomédica Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT04434001 Comparator Feb 2020 → May 2021 acquired coagulation factor deficiency, acute lung injury, congenital heart disease, hemorrhagic disease IRCCS Policlinico S. Donato Terminated No outcome recorded Stop: Enrollment

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2023-02-02 Octapharma Regulatory European authorities approve lyophilised S/D treated plasma octaplasLG® for pre-hospital transfusion octapharma.com ↗
Octapharma AG today announced that European medical authorities have approved the lyophilised presentation of the well-established octaplasLG® - pharmaceutically-licensed S/D treated plasma for transfusion.
2021-04-07 Octapharma Results Study suggests that 4F-PCC can be used as a substitute for frozen plasma for the treatment of bleeding during cardiac surgery octapharma.com ↗
Octapharma announced today the results from a study, investigating whether four-factor prothrombin complex concentrate (4F-PCC) can be used as a substitute for frozen plasma (FP) for the treatment of bleeding during cardiac surgery.
2021-03-03 ADMA Biologics, Inc. Regulatory ADMA Biologics Expands Global Regulatory Approval Presence and Announces FDA Approval to Commence Hepatitis B Plasma Collections admabiologics.com ↗
In conjunction with the South Korean approval, ADMA additionally announced the Kennesaw plasma collection center received FDA approval to implement a Hepatitis B immunization program, enabling ADMA to collect source plasma from donors immunized with an FDA-licensed Hepatitis B vaccine.

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 46 sources stand behind the page.

FieldValueCited text
Known as fresh frozen plasma “two RCTs of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) (47 participants)” PMID 37870112 ↗ Oct 2023
42

“Plasma exchanges with 5% human albumin and fresh frozen plasma” NCT04374539 ↗

“regimen including Fresh frozen plasma 400ml IV day0” NCT01670812 ↗

“Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)” NCT03444324 ↗

“BE1116 compared with fresh frozen plasma (FFP)” NCT07094087 ↗

“Fresh Frozen Plasma (FFP)” NCT02750150 ↗

“Fresh Frozen Plasma” NCT00968487 ↗

NCT00803101 ↗

NCT02726620 ↗

NCT00618098 ↗

NCT06144112 ↗

Show 32 more sources

Known as Blood plasma ClinicalTrials.gov intervention name — accepted as the source's own label NCT04365439 ↗
Known as FFP “Fresh Frozen Plasma (FFP) is a viable, cost-effective alternative to intravenous albumin for managing diuretic resistant edema in children with idiopathic nephrotic syndrome...” NCT07685093 ↗
12

“Patients in the intervention group will receive fresh frozen plasma (FFP) transfusion at a dose of 10-15 mL/kg body weight.” NCT06642493 ↗

“according to the Thromboelastography (TEG) test, CK r-time prolongation, fresh frozen plasma transfusion (FFP) is performed” NCT06144099 ↗

“Patients randomised to the comparator arm will receive Fresh Frozen Plasma (FFP)” NCT03715348 ↗

“Fresh Frozen Plasma (FFP) in Patients Under Vitamin K Antagonist Therapy” NCT00618098 ↗

“Rituximab (Mabthera) , FFP (Fresh Frozen Plasma)” NCT00892827 ↗

“Fresh Frozen Plasma (FFP)” NCT04794348 ↗

“Fresh Frozen Plasma (FFP)” NCT03202524 ↗

“Fresh frozen plasma (FFP)” NCT00928915 ↗

“Fresh Frozen Plasma (FFP)” NCT02750150 ↗

“Fresh Frozen Plasma (FFP)” NCT06062888 ↗

Show 2 more sources

Known as Human Plasma ClinicalTrials.gov intervention name — accepted as the source's own label NCT01221389 ↗
Action Restore “Plasma is commonly used for vitamin K antagonist (VKA) reversal” PMID 26135740 ↗ Jul 2015
Modality Protein / enzyme biologic “fresh frozen plasma (FFP)” PMID 37870112 ↗ Oct 2023
Route Intravenous “fresh frozen plasma infusions intravenously” NCT00618098 ↗