Contributions
Abstract: P13
Type: Poster presentation
Presentation during EHA Scientific Conference on Bleeding Disorders:
On Friday, September 16, 2016 from 14:00 - 15:30
Location: Cristal + Coral
Background
The use of prothombin complex concentrate (PCC) is indicated for patients for the emergency reversal of warfarin in life threatening major haemorrhage and/or emergency bleeding/surgery. Reversal of the anticoagulant effect of Warfarin is achieved immediately and completely with Octaplex. The use of PCC is complicated by risk inducing anaphylaxis and pro-thrombotic complication. This is also considered a high cost drug. The British Committee for the Standard in Haematology (BCSH) has provided extensive recommendation for PCC use.
Aims
To audit how closely BCSH guidelines on the use of PCC are being followed in Croydon University Hospital. Post implements intervention and re-audit was implemented to assess any change.
Method
All cases of Octaplex prescribed within the Trust from January 2015 to June 2016 were identified. The data was gathered from 30 cases during the first 12 months and cut off to 10 cases in the last 18 months using a proforma to select key information including identification of clinical indication, dose given, delay in treatment, warfarin reversal, source of bleeding, use of blood products, and administration of vitamin K and INR results.
Result
Octaplex was given appropriately in 85% of the cases initially audited. Vitamin K was used appropriately in 78% initially and there was no significant difference in the statistical analysis performed (p < 0.01).
Summary/Conclusion
Octaplex has been used for the right indication by the Trust under BCSH guidelines (98%). Intracranial Haemarraghes (ICH) and relation with INR results and potential complication was statistically significant STD [.6465] p 0.01. Despite this the INR was corrected (≤1.5) the average delay in getting INR results was 1 hour – 1 hour and 30 minutes and delay between releasing the PCC from blood bank to infusion.
Octaplex is effective in reversing the majority of patients' anticoagulation. Delay in initiating treatment for the reversal of VKA and adherence to protocols remained as a challenge. In re-audit assessment performed six months later the time frame for adequate administration was reduced to 45 minutes.
References
1. Kiraly, Lyden A, Periyanayagam U, Chan J, Pang P, Management of hemorrhage complicated by novel oral anticoagulants in the emergency department: case report from the northwestern emergency medicine residency, Am. J. Ther. 20 (2013) 300–306.
2. Evans G, Luddington R, Baglin T: Beriplex P/N reverses severe warfarin-induced overanticoagulation immediately and completely in patients presenting with major bleeding. Br J Haematol 2001, 115: 998-1001.
3. Franchini M, Lippi G, Prothrombin complex concentrates: an update, Blood Transfus. 8 (2010) 149–154.
4. Eerenberg E, Kamphuisen P, Sijpkens M, Meijers J, Buller H, Levi M, Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects, Circulation 124 (2011) 1573–1579.
5. Bershad E, Suarez J, Prothrombin complex concentrates for oral anticoagulant therapy-related intracranial hemorrhage: a review of the literature, Neurocrit. Care. 12 (2010) 403–413.
a. Godier, A. Miclot, B. Le Bonniec, M. Durand, A.M. Fischer, J. Emmerich, et al., Evaluation of prothrombin complex concentrate and recombinant activated factor VII to reverse rivaroxaban in a rabbit model, Anesthesiology 116 (2012) 94–102.
6. Ostermann H, Haertel S, Knaub S, Kalina U, Jung K, Pabinger I,Pharmacokinetics of Beriplex P/N prothrombin complex concentrate in healthy volunteers, Thromb. Haemost. 98 (2007) 790–797
7. Palareti G, Leali N, Coccheri S, Poggi M, Manotti C, D'Angelo A, Pengo V, Erba N, Moia M, Ciavarella N, Devoto G, Berrettini M, Musolesi S: Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT). Italian Study on Complications of Oral Anticoagulant Therapy. Lancet 1996, 348: 423-428.
8. Pabinger I, Brenner B, Kalina U, Knaub S, Nagy A, Ostermann H: Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost 2008, 6: 622-631.
9. Kalina U. , Bickhard H., Schulte S., Biochemical comparison of seven commercially available prothrombin complex concentrates, Int. J. Clin. Pract. 62 (2008) 1614–1622.
10. Sjoblom L, Hardemark HG, Lindgren A, Norrving B, Fahlen M, Samuelsson M, Stigendal L, Stockelberg D, Taghavi A, Wallrup L, Wallvik J: Management and prognostic features of intracerebral hemorrhage during anticoagulant therapy: a Swedish multicenter study. Stroke 2001, 32: 2567-2574.
11. Leissinger CA, Blatt PM, Hoots WK, Ewenstein B: Role of prothrombin complex concentrates in reversing warfarin anticoagulation: A review of the literature. Am J Hematol 2008, 83: 137-143.
12. Lubetsky, R. Hoffman, R. Zimlichman, A. Eldor, J. Zvi, V. Kostenko, et al., Efficacy and safety of a prothrombin complex concentrate (Octaplex) for rapid reversal of oral anticoagulation, Thromb. Res. 113 (2004) 371–378.
13. Hylek EM, Evans-Molina C, Shea C, Henault LE, Regan S: Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 2007, 115: 2689-2696.
14. Levy JH, Kenichi KA, Dietrich W: Perioperative hemostatic management of patients treated with vitamin K antagonists. Anesthesiology 2008, 109: 918-926.
15. Lankiewicz MW, Hays J, Friedman KD, Tinkoff G, Blatt PM: Urgent reversal of warfarin with prothrombin complex concentrate. J Thromb Haemost 2006, 4: 967-970.
Abstract: P13
Type: Poster presentation
Presentation during EHA Scientific Conference on Bleeding Disorders:
On Friday, September 16, 2016 from 14:00 - 15:30
Location: Cristal + Coral
Background
The use of prothombin complex concentrate (PCC) is indicated for patients for the emergency reversal of warfarin in life threatening major haemorrhage and/or emergency bleeding/surgery. Reversal of the anticoagulant effect of Warfarin is achieved immediately and completely with Octaplex. The use of PCC is complicated by risk inducing anaphylaxis and pro-thrombotic complication. This is also considered a high cost drug. The British Committee for the Standard in Haematology (BCSH) has provided extensive recommendation for PCC use.
Aims
To audit how closely BCSH guidelines on the use of PCC are being followed in Croydon University Hospital. Post implements intervention and re-audit was implemented to assess any change.
Method
All cases of Octaplex prescribed within the Trust from January 2015 to June 2016 were identified. The data was gathered from 30 cases during the first 12 months and cut off to 10 cases in the last 18 months using a proforma to select key information including identification of clinical indication, dose given, delay in treatment, warfarin reversal, source of bleeding, use of blood products, and administration of vitamin K and INR results.
Result
Octaplex was given appropriately in 85% of the cases initially audited. Vitamin K was used appropriately in 78% initially and there was no significant difference in the statistical analysis performed (p < 0.01).
Summary/Conclusion
Octaplex has been used for the right indication by the Trust under BCSH guidelines (98%). Intracranial Haemarraghes (ICH) and relation with INR results and potential complication was statistically significant STD [.6465] p 0.01. Despite this the INR was corrected (≤1.5) the average delay in getting INR results was 1 hour – 1 hour and 30 minutes and delay between releasing the PCC from blood bank to infusion.
Octaplex is effective in reversing the majority of patients' anticoagulation. Delay in initiating treatment for the reversal of VKA and adherence to protocols remained as a challenge. In re-audit assessment performed six months later the time frame for adequate administration was reduced to 45 minutes.
References
1. Kiraly, Lyden A, Periyanayagam U, Chan J, Pang P, Management of hemorrhage complicated by novel oral anticoagulants in the emergency department: case report from the northwestern emergency medicine residency, Am. J. Ther. 20 (2013) 300–306.
2. Evans G, Luddington R, Baglin T: Beriplex P/N reverses severe warfarin-induced overanticoagulation immediately and completely in patients presenting with major bleeding. Br J Haematol 2001, 115: 998-1001.
3. Franchini M, Lippi G, Prothrombin complex concentrates: an update, Blood Transfus. 8 (2010) 149–154.
4. Eerenberg E, Kamphuisen P, Sijpkens M, Meijers J, Buller H, Levi M, Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects, Circulation 124 (2011) 1573–1579.
5. Bershad E, Suarez J, Prothrombin complex concentrates for oral anticoagulant therapy-related intracranial hemorrhage: a review of the literature, Neurocrit. Care. 12 (2010) 403–413.
a. Godier, A. Miclot, B. Le Bonniec, M. Durand, A.M. Fischer, J. Emmerich, et al., Evaluation of prothrombin complex concentrate and recombinant activated factor VII to reverse rivaroxaban in a rabbit model, Anesthesiology 116 (2012) 94–102.
6. Ostermann H, Haertel S, Knaub S, Kalina U, Jung K, Pabinger I,Pharmacokinetics of Beriplex P/N prothrombin complex concentrate in healthy volunteers, Thromb. Haemost. 98 (2007) 790–797
7. Palareti G, Leali N, Coccheri S, Poggi M, Manotti C, D'Angelo A, Pengo V, Erba N, Moia M, Ciavarella N, Devoto G, Berrettini M, Musolesi S: Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT). Italian Study on Complications of Oral Anticoagulant Therapy. Lancet 1996, 348: 423-428.
8. Pabinger I, Brenner B, Kalina U, Knaub S, Nagy A, Ostermann H: Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost 2008, 6: 622-631.
9. Kalina U. , Bickhard H., Schulte S., Biochemical comparison of seven commercially available prothrombin complex concentrates, Int. J. Clin. Pract. 62 (2008) 1614–1622.
10. Sjoblom L, Hardemark HG, Lindgren A, Norrving B, Fahlen M, Samuelsson M, Stigendal L, Stockelberg D, Taghavi A, Wallrup L, Wallvik J: Management and prognostic features of intracerebral hemorrhage during anticoagulant therapy: a Swedish multicenter study. Stroke 2001, 32: 2567-2574.
11. Leissinger CA, Blatt PM, Hoots WK, Ewenstein B: Role of prothrombin complex concentrates in reversing warfarin anticoagulation: A review of the literature. Am J Hematol 2008, 83: 137-143.
12. Lubetsky, R. Hoffman, R. Zimlichman, A. Eldor, J. Zvi, V. Kostenko, et al., Efficacy and safety of a prothrombin complex concentrate (Octaplex) for rapid reversal of oral anticoagulation, Thromb. Res. 113 (2004) 371–378.
13. Hylek EM, Evans-Molina C, Shea C, Henault LE, Regan S: Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 2007, 115: 2689-2696.
14. Levy JH, Kenichi KA, Dietrich W: Perioperative hemostatic management of patients treated with vitamin K antagonists. Anesthesiology 2008, 109: 918-926.
15. Lankiewicz MW, Hays J, Friedman KD, Tinkoff G, Blatt PM: Urgent reversal of warfarin with prothrombin complex concentrate. J Thromb Haemost 2006, 4: 967-970.