From the Guidelines
Fresh Frozen Plasma (FFP) does not have a significant role in managing bleeding induced by Rivaroxaban (Xarelto, direct oral anticoagulant).
Rationale
- The British Society of Gastroenterology guidelines state that FFP does not reverse the anticoagulant effect of Direct Oral Anticoagulants (DOACs) to any appreciable degree and no clinical benefit has been demonstrated 1.
- Another study published in Gut in 2019 also mentions that Vitamin K, FFP or protamine sulfate are ineffective in managing severe GI bleeding with DOACs 1.
- The same study suggests that prothrombin complex concentrate reverses the anticoagulant effect of rivaroxaban, but not dabigatran, in healthy volunteers, and specific antidotes like idarucizumab and andexanet are available for managing life-threatening haemorrhage on direct oral anticoagulants 1.
- Key points to consider in managing bleeding induced by Rivaroxaban include:
- Withholding the drug and waiting for the anticoagulant effects to dissipate
- Using specific antidotes like idarucizumab or andexanet for life-threatening haemorrhage
- Considering treatment with prothrombin complex concentrate
- Restarting DOAC treatment at a maximum of 7 days after haemorrhage, depending on the patient's risk of thrombosis and rebleeding.
From the FDA Drug Label
Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.
The FDA drug label suggests that plasma products may be used to partially reverse laboratory anticoagulation parameters in the event of bleeding induced by Rivaroxaban. However, it does not specifically state that Fresh Frozen Plasma (FFP) is recommended for this purpose. Since the label does mention plasma products, and FFP is a type of plasma product, it can be inferred that FFP may have a role in managing bleeding induced by Rivaroxaban, but this is not explicitly stated. Therefore, based on the available information, it can be concluded that FFP may have a role in managing bleeding induced by Rivaroxaban, but this should be done with caution and under close monitoring, as the evidence is not definitive 2.
From the Research
Role of Fresh Frozen Plasma in Managing Bleeding Induced by Rivaroxaban
- The use of Fresh Frozen Plasma (FFP) in managing bleeding induced by Rivaroxaban, a direct oral anticoagulant, is not widely recommended 3, 4.
- A study published in 2013 suggests that FFP may not be effective in reversing bleeding related to novel oral anticoagulants, including Rivaroxaban 3.
- Another study published in 2012 notes that strategies for management of bleeding and reversal of anticoagulant effects from warfarin include vitamin K, fresh frozen plasma, and prothrombin complex concentrates, but does not specifically recommend FFP for Rivaroxaban-related bleeding 4.
- A retrospective cohort analysis published in 2023 found that FFP was used in only 1% of patients with Rivaroxaban-related major bleeding, suggesting that it is not a commonly used treatment for this condition 5.
- An in vitro study published in 2018 found that FFP did not significantly alter the hypocoagulant state induced by Rivaroxaban, and that combined use of plasma and prothrombin complex concentrate may be a more effective resuscitation approach 6.
- A study published in 2014 found that transfusion of FFP was significantly less in patients treated with Rivaroxaban compared to those treated with warfarin, suggesting that FFP may not be as necessary for managing bleeding in patients taking Rivaroxaban 7.
Alternative Treatments for Rivaroxaban-Related Bleeding
- Prothrombin complex concentrate (PCC) is often recommended as a treatment for Rivaroxaban-related bleeding 3, 5, 6.
- Tranexamic acid (TXA) may also be used to manage Rivaroxaban-related bleeding 5, 6.
- Support and observation are likely to be effective for the majority of patients with Rivaroxaban-related bleeding, due to the short half-life of the drug 4.