Last reviewed 2026-04-22 · How we verify

Prothrombin Complex Concentrate, Human

Prothrombin Complex Concentrate replaces deficient vitamin K-dependent clotting factors (II, VII, IX, X) to restore coagulation cascade function and reverse anticoagulation.

Prothrombin Complex Concentrate replaces deficient vitamin K-dependent clotting factors (II, VII, IX, X) to restore coagulation cascade function and reverse anticoagulation. Used for Reversal of warfarin-induced anticoagulation in acute bleeding, Correction of vitamin K-dependent factor deficiency in liver disease, Management of disseminated intravascular coagulation (DIC).

At a glance

Mechanism of action

PCC is a pooled plasma-derived product containing the vitamin K-dependent factors II, VII, IX, and X (4-factor PCC) or factors II, VII, IX, X plus proteins C and S (enhanced formulations). It rapidly restores these factors in patients with deficiency due to warfarin overdose, liver disease, or disseminated intravascular coagulation, thereby correcting the prolonged prothrombin time and restoring hemostatic capacity.

Approved indications

• Reversal of warfarin-induced anticoagulation in acute bleeding
• Correction of vitamin K-dependent factor deficiency in liver disease
• Management of disseminated intravascular coagulation (DIC)

Common side effects

• Thromboembolism (venous thromboembolism, myocardial infarction, stroke)
• Allergic reactions / hypersensitivity
• Fever
• Headache
• Nausea

Key clinical trials

• HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients (PHASE3)
• Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B (PHASE2)
• Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study ) (PHASE3)
• Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery (PHASE4)
• Treatment of Hemophilia A Patients With FVIII Inhibitors
• Study of AAV5-hFIX in Severe or Moderately Severe Haemophilia B
• Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery (PHASE3)
• A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants (PHASE1)

Primary sources

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