Maximum Clot Firmness

RiaSTAP improves maximum clot firmness (MCF)*, a surrogate laboratory measure of hemostatic efficacy

MCF (mm), intent-to-treat population
Time Point n Mean ± SD Median (range)
Pre-infusion 13 0 ± 0 0 (0 - 0)
1 hour post-infusion 13 10.3 ± 2.7 10.0 (6.5 - 16.5)
Mean change (primary analysis)a 15b 8.9 ± 4.4 9.5 (0 - 16.5)
  • Clot firmness is a functional parameter that depends on activation of coagulation, fibrinogen content of the sample, and polymerization/crosslinking of the fibrin network
  • RiaSTAP was found to be effective in increasing clot firmness in patients with congenital fibrinogen deficiency (afibrinogenemia) as measured by thromboelastometry
  • Results demonstrated significantly higher MCF values after administration of RiaSTAP than at baseline (P < 0.0001)

*NOTE: RiaSTAP was approved using maximum clot firmness (MCF) as a surrogate marker likely to predict clinical benefit. Thus, the hemostatic efficacy of RiaSTAP in acute bleeding episodes has not been established.

  1. p-value < 0.0001
  2. The mean change was set to 0 for 2 subjects with missing MCF data

Important Safety Information

RiaSTAP®, Fibrinogen Concentrate (Human), is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products.

Monitor patients for early signs of anaphylaxis or hypersensitivity reactions and if necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving RiaSTAP; weigh the benefits of administration versus the risks of thrombosis.

RiaSTAP is made from human blood. 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.

The most serious adverse reactions observed are thrombotic episodes (pulmonary embolism, myocardial infarction, deep vein thrombosis) and anaphylactic reactions. The most common adverse reactions observed in clinical studies (frequency >1%) were fever and headache.

Indications

RIASTAP is indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Please see full prescribing information for RiaSTAP.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.