Real World Data | Kcentra® (Prothrombin complex concentrate [human])

Proven in clinical trials, validated in the real world

An FDA postmarketing requirement observational study was conducted in partnership between Kaiser Permanente, CSL Behring, and board-certified physician reviews.2

As presented in the Journal of Thrombosis and Thrombolysis: “Thromboembolism after treatment with 4-factor prothrombin complex concentrate or plasma for warfarin-related bleeding”

Study design2
  • Multicenter, observational study using Kaiser Permanente databases
  • Comparison of 45-day risk of TE events in a matched real-world cohort of hospitalized adults
  • 2238 patients with no history of TE events: KCENTRA (N=1119) or plasma (N=1119)
  • Diverse patients across the spectrum of age, sex, race/ethnicity and socioeconomic status
  • Bleeding types included: 68% ICH (N=1514), 31% GI (N=689), 1% other (N=35)

Primary outcome

No significant adjusted difference in the 45-day risk of thromboembolism after receiving KCENTRA vs plasma

While this observational data demonstrated TE event safety, patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Please note the boxed warning regarding arterial and venous thromboembolic complications.

Secondary outcome

Adjusted all-cause mortality risk within 45 days post-treatment was significantly lower in those receiving KCENTRA compared with plasma (aHR: 0.59, 95% CI: 0.47-0.73)

Purple shield star


Clinical Practice Guidelines Recommend PCC Over Plasma to reverse the Effects of Warfarin

  • NCS, SCCM, and ASGE – 20163,7
  • ACEP – 20194
  • ACC – 20175
  • ACCP – 20126
  • ACS and ASH – 20188,9

Open access to the online article can be found here.

Top of Page Important Safety Information
Important Safety Information & Indications

Important Safety Information


Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving KCENTRA, and inform them of signs and symptoms of thromboembolic events. KCENTRA was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. KCENTRA might not be suitable for patients with thromboembolic events in the prior 3 months.

KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation. Because KCENTRA contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).

Hypersensitivity reactions to KCENTRA may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.

In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving KCENTRA were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

KCENTRA is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.


KCENTRA®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. KCENTRA is for intravenous use only.

Please see full prescribing information for KCENTRA.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or

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