Neurocritical Care

, Volume 7, Issue 2, pp 136–139 | Cite as

Utilization of recombinant activated factor VII for intracranial hematoma evacuation in coagulopathic nonhemophilic neurosurgical patients with normal international normalized ratios

  • Shearwood McClellandIII
  • Eun Kyung Won
  • Cornelius H. Lam
Original Paper



Recombinant activated Factor VII (rFVIIa) has recently gained popularity for rapid reversal of coagulopathy during operative neurosurgery. Patients undergoing chronic subdural hematoma (CSDH) or epidural hematoma (EDH) evacuation often have their coagulation status judged by preoperative international normalized ratio (INR). We present our experience in two patients with significant clinical coagulopathy who were successfully reversed with rFVIIa in the setting of normal INR.


Patient one was a 79-year-old man with history of prostate cancer and three previous operative left CSDH evacuations, each complicated by coagulopathic bleeding, who presented with new-onset left EDH. Patient two was a 27-year-old woman with relapsed acute myelogenous leukemia with bilateral CSDH and mass effect on MRI. Neither patient had hemophilia, and preoperative INR was 1.2 in each case. Both patients underwent evacuation in the operating room, preceded by rFVIIa administration.


Patient one underwent removal of his previous craniotomy flap followed by EDH evacuation. In patient two, coagulopathic bleeding upon surgical approach necessitated an additional dose of rFVIIa. Burrhole evacuation was well-tolerated with visible brain re-expansion following irrigation. Each case occurred with minimal blood loss and relatively easy hemostasis, with postoperative CT and clinical course revealing adequate evacuation. Neither patient experienced thromboembolic complications or required re-operation.


These two patients are the first to be examined for the use of rFVIIa for reversal of clinical coagulopathy in the setting of normal INR. Our experience suggests that normal INR should not be a deterrent for patients to receive rFVIIa in the setting of strong neurosurgical suspicion for underlying clinical coagulopathy.


Recombinant activated factor VII International normalized ratio Chronic subdural hematoma Epidural hematoma Nonhemophilic 


  1. 1.
    Fewel ME, Park P. The emerging role of recombinant-activated factor VII in neurocritical care. Neurocrit Care 2004;1:19–29PubMedCrossRefGoogle Scholar
  2. 2.
    Hartmann M, Sucker C, Messing M. Recombinant activated factor VII in the treatment of near-fatal bleeding during pediatric brain tumor surgery. Report of two cases and review of the literature. J Neurosurg 2006;104(1 Suppl):55–8 PubMedGoogle Scholar
  3. 3.
    Karadimov D, Binev K, Nachkov Y, Platikanov V. Use of activated recombinant Factor VII (NovoSeven) during neurosurgery. J Neurosurg Anesthesiol 2003;15:330–2PubMedCrossRefGoogle Scholar
  4. 4.
    Lin J, Hanigan WC, Tarantino M, Wang J. The use of recombinant activated factor VII to reverse warfarin-induced anticoagulation in patients with hemorrhages in the central nervous system: preliminary findings. J Neurosurg 2003;98:737–40PubMedCrossRefGoogle Scholar
  5. 5.
    Park P, Fewel ME, Garton HJ, Thompson BG, Hoff JT. Recombinant activated factor VII for the rapid correction of coagulopathy in nonhemophilic neurosurgical patients. Neurosurgery. 2003;53:34–9PubMedCrossRefGoogle Scholar
  6. 6.
    Roitberg B, Emechebe-Kennedy O, Amin-Hanjani S, Mucksavage J, Tesoro E. Human recombinant factor VII for emergency reversal of coagulopathy in neurosurgical patients: a retrospective comparative study. Neurosurgery 2005;57:832–6PubMedCrossRefGoogle Scholar
  7. 7.
    Powner DJ, Hartwell EA, Hoots WK. Counteracting the effects of anticoagulants and antiplatelet agents during neurosurgical emergencies. Neurosurgery 2005;57:823–31PubMedCrossRefGoogle Scholar
  8. 8.
    Enomoto TM, Thorborg P. Emerging off-label uses for recombinant activated factor VII: grading the evidence. Crit Care Clin 2005;21:611–32PubMedCrossRefGoogle Scholar
  9. 9.
    Brody DL, Aiyagari V, Shackleford AM, Diringer MN. Use of recombinant factor VIIa in patients with warfarin-associated intracranial hemorrhage. Neurocrit Care 2005;2:263–7PubMedCrossRefGoogle Scholar
  10. 10.
    Dunkley SM, Mackie F. Recombinant factor VIIa used to control massive haemorrhage during renal transplantation surgery; vascular graft remained patent. Hematology 2003;8:263–4PubMedCrossRefGoogle Scholar
  11. 11.
    Huang WY, Kruskall MS, Bauer KA, Uhl L, Shaz BH. The use of recombinant activated factor VII in three patients with central nervous system hemorrhages associated with factor VII deficiency. Transfusion 2004;44:1562–6PubMedCrossRefGoogle Scholar
  12. 12.
    Johansson PI, Eriksen K, Alsbjorn B. Rescue treatment with recombinant factor VIIa is effective in patients with life-threatening bleedings secondary to major wound excision: a report of four cases. J Trauma 2006;61:1016–8PubMedGoogle Scholar
  13. 13.
    Lucey MA, Myburgh JA. Recombinant activated factor VII for exsanguinating haemorrhage post bilateral lung transplantation for extra-corporeal lung support-dependent respiratory failure. Anaesth Intensive Care 2003;31:465–9PubMedGoogle Scholar
  14. 14.
    Mindikoglu AL, Anantharaju A, George M, Leone N, Bejna J, Van Thiel DH. Splenic embolization in a Jehovah’s Witness: role of recombinant human factor VIIa. Hepatogastroenterology 2003;50:1697–9PubMedGoogle Scholar
  15. 15.
    Pychynska-Pokorska M, Moll JJ, Krajewski W, Jarosik P. The use of recombinant coagulation factor VIIa in uncontrolled postoperative bleeding in children undergoing cardiac surgery with cardiopulmonary bypass. Pediatr Crit Care Med 2004;5:246–50PubMedCrossRefGoogle Scholar
  16. 16.
    Segal S, Shemesh IY, Blumenthal R, Yoffe B, Laufer N, Ezra Y, Levy I, Mazor M, Martinowitz U. Treatment of obstetric hemorrhage with recombinant activated factor VII (rFVIIa). Arch Gynecol Obstet 2003;268:266–7PubMedCrossRefGoogle Scholar
  17. 17.
    Tawfick WA, Tawfik S, Hynes N, Mahendran B, Sultan S. Critical bleeding in vascular surgery: expanding the indication of recombinant activated factor VII. Vascular 2006;14:32–7PubMedCrossRefGoogle Scholar
  18. 18.
    Mayer SA, Brun NC, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T. Europe/AustralAsia NovoSeven ICH Trial Investigators. Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke 2005;36:74–9PubMedCrossRefGoogle Scholar
  19. 19.
    Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T. Recombinant activated factor VII intracerebral hemorrhage trial investigators. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 2005;352:777–85PubMedCrossRefGoogle Scholar
  20. 20.
    Putnam KG, Bohn RL, Ewenstein BM, Winkelmayer WC, Avorn J. A cost minimization model for the treatment of minor bleeding episodes in patients with haemophilia A and high-titre inhibitors. Haemophilia 2005;11:261–9PubMedCrossRefGoogle Scholar
  21. 21.
    O’Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA 2006;295:293–8PubMedCrossRefGoogle Scholar

Copyright information

© Humana Press Inc. 2007

Authors and Affiliations

  • Shearwood McClellandIII
    • 1
  • Eun Kyung Won
    • 1
  • Cornelius H. Lam
    • 1
  1. 1.Department of NeurosurgeryUniversity of MinnesotaMinneapolisUSA

Personalised recommendations