Key result
In 299 patients with severe bleeding, the rFVIIa and 3-factor PCC combination produced the greatest INR decrease in warfarin patients but increased clotting complications compared to other agents.
Why the study?
Does rFVIIa, 4-factor PCC, or a combination of rFVIIa and 3-factor PCC improve bleeding outcomes in warfarin and non-warfarin patients with severe bleeding?
Observational (n=299)
No
Does rFVIIa, 4-factor PCC, or a combination of rFVIIa and 3-factor PCC improve bleeding outcomes in warfarin and non-warfarin patients with severe bleeding?
4-factor PCC may be the most prudent for warfarin patients with severe bleeding, while rFVIIa warrants further study in non-warfarin patients.
Combination reversal may optimize INR correction yet heighten thrombotic risk in warfarin bleeding; leaves open preferred strategy pending prospective trials.
In case of severe bleeding, the physician must rapidly and effectively halt bleeding without the risk of thromboembolic complications. Despite widespread use, no study has directly compared recombinant activated factor VII (rFVIIa), the rFVIIa and 3-factor prothrombin complex concentrate (PCC) combination ("combination"), and 4-factor PCC on their effectiveness in improving patient outcomes. This study examined the medical records of 299 patients, 65.2% on warfarin prior to admission, who received these hemostatic agents and were admitted to an ICU or through the emergency department at Oregon Health & Science University. Mortality, length of stay, change in international normalized ratio (INR), plasma use, and number of thromboembolic complications were used to assess effectiveness. In patients receiving warfarin, the combination group had the greatest decrease in INR as well as lowest overall INR, but experienced a higher number of clotting complications, while the rFVIIa group used the most plasma. Non-warfarin patients in the combination group had the shortest length of stay among survivors, but the rFVIIa group had the lowest mortality. Based on this data, it may be prudent to further study the use of rFVIIa in treating extreme bleeding in the non-warfarin patient, while this study supports other data that 4-factor PCC may be the most prudent for the warfarin patient. Am. J. Hematol. 91:705-708, 2016.
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DeLoughery et al. (2016) conducted an observational in Severe bleeding (n=299). rFVIIa, 4-factor PCC, and rFVIIa + 3-factor PCC combination vs. Compared against each other was evaluated on Mortality, length of stay, change in INR, plasma use, and number of thromboembolic complications. In 299 patients with severe bleeding, the rFVIIa and 3-factor PCC combination produced the greatest INR decrease in warfarin patients but increased clotting complications compared to other agents.
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