THERAPY DOSSIER · th-04f2e8c93670

Human four-factor prothrombin complex concentrate (Kcentra)

Biologic

Evidence & regulatory context

Mechanism: Not recorded
Target: Not recorded
Injury models: Haemorrhage/shock
Reported indication: Not recorded
First approval: Not recorded
Development stage: Not recorded
ChEMBL record: Not recorded
ChEMBL max phase: Not recorded
Synonyms: Not recorded
Note: Not recorded

Clinical trials 2

2 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT02557672 ↗Injury indicationPHASE4completed

Prothrombin Complex Concentrate vs Fresh Frozen Plasma for Post-CPB Coagulopathy

Blood Loss, Surgical

Enrolment: 106 · Results not recorded

NCT04867837 ↗Injury indicationPHASE3terminated

Four-factor PCC (OCTAPLEX) in Acute Major Bleeding on DOAC (Factor Xa Inhibitor)

Acute Major Bleeding

Enrolment: 100 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 32697449 ↗2020No effect reported

The effects of human prothrombin complex concentrate on hemorrhagic shock-induced lung injury in rats: Implications for testing human blood products in rodents.

RatHaemorrhage/shockControlledSprague-Dawleymale20 IU/kg or 50 IU/kg added to Lactated Ringer's solutionAt resuscitation, after 60 minutes of controlled haemorrhage

Model: Splenic injury with controlled haemorrhage for 60 minutes followed by resuscitation

Prothrombin complex concentrate at 20 or 50 IU/kg did not reduce haemorrhagic shock-induced pulmonary vascular permeability in rats, although it modestly increased clotting potential; only rat fresh frozen plasma reduced pulmonary leak, suggesting a xenogenic species effect.

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.75. Machine-extracted fields require source verification.

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