|Mechanism of Action||Factor Xa Inhibitor||Factor Xa Inhibitor||Inhibitor of Vitamin K dependent clotting factors (II, IX, VII, and X)||Direct|
|Renal (36% unchanged|
|Renal, primarily as|
|Renal (80% unchanged|
Prothrombin Complex Concentrate Products and What’s in Them?
- Profilnine SD and Bebulin
- Unactivte PCC, 3-Factor
- Cogulation Factors
- II, IX, X
- Unactivated PCC, 4-Factor
- Coagulation Factors
- II, VII, IX, X
- Activated PCC, 4-Factors
- Coagulation factors
- II, VII, IX, X
- Activated factor VIIa
- Coagulation Factors
- Recombinant VIIa
|Title||Berger K, et al. A Low-Dose 4F-PCC Protocol for DOAC-Associated Intracranial Hemorrhage. J Intensive Care Med. 2019 Apr 14. [Epub ahead of print]|
|Aim/Clinical ?||The objective of this study was to evaluate the effectiveness and safety of a low-dose 4F-PCC protocol in DOAC-associated ICH, through assessment of hemostatic effectiveness and thromboembolic events.|
|Design||This was a retrospective study|
|Population||19 ICH patients who were 18 years of age or older and received at least one dose of 4F-PCC for DOAC associated ICH|
|Inclusion/Exclusion||Patients who received 4F-PCC at an outside hospital were excluded|
|Intervention||25 units/kg 4F-PCC per the hospital reversal guideline|
|Comparison||No comparator group|
|Baseline Characteristic||Included 68.2% of patients taking rivaroxaban and 22.7% taking apixaban. 50% were male and the median age was 79.5 yrs. Mean dose of PCC 2000 units|
|Outcomes||– Hemostatic effectiveness was 94.7% overall (18/19 patients). |
– Hemostatic effectiveness was 92.9% for rivaroxaban, 100% for apixaban, and 100% for dabigatran reversals.
(9.1%) developed thromboembolic events after 4F-PCC administration.
– One patient developed an ischemic stroke 0.5 days after 4F-PCC; the second patient developed a left lower extremity DVT 7.3 days after 4F-PCC.
-Hospital mortality was 18.2% (4/22 patients)
|Conclusion||This study observed a high hemostatic effectiveness rate with a lower dose of 4F-PCC compared to current guideline recommendations. Two patients developed thromboembolic events within 14 days of 4FPCC administration, including one patient who received a repeat dose.|
|Thoughts||36.8% (7/19 patients) of our evaluable patients had a SAH which carries a lower likelihood for hematoma expansion. Follow-up duration of 14 days to assess for thromboembolic events, While several studies have used a longer assessment period. The hemostatic effectiveness definition was based solely on the documented interpretation of CT head imaging, which was not independently reviewed by a neurosurgeon or neurologist. Many of the patients received platelet transfusions, as this study dates included patients treated prior to publication of the PATCH trial.|
|Title||Dager WE, et al. Effect of low and moderate dose FEIBA to reverse major bleeding in patients on direct oral anticoagulants. Thromb Res. 2019 Jan;173:71-76.|
|Aim/Clinical?||To evaluate the outcomes of our dosing approach in patients prescribed a DOAC and experiencing a bleeding event.|
|Design||Single-center, retrospective analysis|
|Population||64 patients who received FEIBA to treat a bleeding event or mitigate potential bleeding during a high-risk procedure|
|Inclusion/Exclusion||Patients were excluded if they were not receiving a DOAC, had any form of hemophilia, were pregnant, a prisoner, or<18 years of age|
|Intervention||Low dose FEIBA < 20 units/kg vs Moderate dose FEIBA (24.3 units/kg)|
|Comparison||No placebo group|
|Baseline Characteristic||Mean age 74 yr old, 80% on anticoagulation for Afib, 29% had ICH, 16 % had GI bleeding. 25% on dabigatran, 31% on apixaban, 44% on rivaroxaban|
|Outcomes||Of the 64 patients in the analysis, an additional dose was requested in 6 patients. (90.62% hemostasis)|
– 30 day event rates included 5 thromboembolic events (8%) and 9 (14%) patients expired.
Follow-up CT-imaging for ICH, endoscopy/colonoscopy, or interventional radiology exams did not reveal any clinically concerning active bleeding or hematoma expansion except in 2 ICH patients with slight expansion between imaging sessions.
Reduction of apixaban specific Anti-Xa by 76% and rivaroxaban by 56% at 3.3 hours post aPCC
|Conclusion||25 units/kg FEIBA or lower appears to be safe and have the potential to expedite hemostasis in critical bleeding settings.|
|Thoughts||This was a single-center, non-randomized retrospective analysis with no comparator. Only a low and moderate FEIBA dosing cohort was evaluated, limiting any comparison to higher doses that have been explored.|
- Dabi A, et al. Crit Care Res Pract 2018;4907164.
- Smith S, et al. J Thromb Thrombolysis. 2019 Apr 2.
- Berger K, et al. J Intensive Care Med. 2019 Apr 14.
- Dager WE, et al. Thromb Res. 2019 Jan;173:71-76.
- Schulman S, et al. Thromb Haemost 2018;118:842 51.
- Santibanez M, et al. J Crit Care 2018;48:183 90
- Allison TA, et al. J Intensive Care Med 2018 Epub ahead of print].
- Tao J, et al. J Intensive Care 2018;6:34.
- Majeed A, et al. Blood 2017;130:1706 12.
Podcast: Play in new window | Download
Subscribe: Apple Podcasts | Google Podcasts | Stitcher | RSS | http://pharmsohard.com/