Drugs / Frozen Plasma
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00302965 | Apr 2005 → Dec 2006 | blood coagulation disease | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02561026 | Jan 2016 → Aug 2018 | blood coagulation disease | Ottawa Hospital Research Institute | Unknown | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT04114643 Comparator | Sep 2019 → Jul 2020 | — | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 4 | NCT04534751 Comparator | Apr 2021 → Dec 2023 | blood coagulation disease | University Health Network, Toronto | Unknown | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
Patients in the 4F-PCC group (N = 54) had a 44% (P < 0.001) lower exposure to allogeneic blood components than the FP group (N = 47), primarily due to a significantly lower requirement of additional FP transfusions (94% lower, P < 0.001) |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-04-07 | Octapharma | Study suggests that 4F-PCC can be used as a substitute for frozen plasma for the treatment of bleeding during cardiac surgery octapharma.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Frozen Plasma | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00302965 ↗ |
| Action | Restore | “coagulation factor replacement” NCT04114643 ↗ |