Original Article

Preliminary Experience with the Use of Recombinant Factor VIIa to Treat Coagulation Disturbances in Pediatric Patients

Authors: Joseph D. Tobias, MD, Kelly Groeper, MD, John W. Berkenbosch, MD

Abstract

Objective: This study evaluates the efficacy of recombinant factor VII (rVIIa) in the treatment of coagulation dysfunction in pediatric patients.


Methods: We retrospectively reviewed the records of pediatric patients who received rVIIa in the intensive care unit or operating room for treatment of coagulopathy. Case series in the literature were also reviewed.


Results: Ten patients, ranging in age from 3 months to 19 years, received 22 doses of rVIIa. Seven of the 10 patients had received fresh frozen plasma and cryoprecipitate before the administration of rVIIa without effect. All 10 patients had a fibrinogen level above 100 mg/dl and platelet count above 100,000/mm3 at the time of rVIIa administration. After rVIIa administration, there were significant decreases in prothrombin time, international normalized ratio, and partial thromboplastin time. No adverse effects were noted.


Conclusion: Recombinant factor VIIa can be used to effectively reverse coagulation disturbances in the pediatric patient even when treatment with fresh frozen plasma has failed. Given its therapeutic potential, prospective, randomized trials are warranted.

This content is limited to qualifying members.

Existing members, please login first

If you have an existing account please login now to access this article or view purchase options.

Purchase only this article ($25)

Create a free account, then purchase this article to download or access it online for 24 hours.

Purchase an SMJ online subscription ($75)

Create a free account, then purchase a subscription to get complete access to all articles for a full year.

Purchase a membership plan (fees vary)

Premium members can access all articles plus recieve many more benefits. View all membership plans and benefit packages.

References

1. Cote CJ, Drop LJ, Hoaglin DC, Daniels AL, Young ET. Ionized hypocalcemia after fresh frozen plasma administration to thermally injured children: Effects of infusion rate, duration, and treatment with calcium chloride. Anesth Analg 1988; 67: 152–160.
 
2. Hedner U, Glazer S, Pingel K, et al. Successful use of recombinant factor VIIa in patient with severe haemophilia A during synovectomy. Lancet 1988; 2: 1193(letter).
 
3. Hedner U. Recombinant coagulation factor VIIa: From the concept to clinical application in hemophilia treatment in 2000. Semin Thromb Hemost 2000; 26: 363–366.
 
4. Chuansumrit A, Chantarojanasiri T, Isarangkura P, et al. Recombinant activated factor VII in children with acute bleeding resulting from liver failure and disseminated intravascular coagulation. Blood Coagul Fibrinolysis 2000; 11 (Suppl 1): S101–S105.
 
5. Schulman S, Bech Jensen M, Varon D, et al. Feasibility of using recombinant factor VIIa in continuous infusion. Thromb Haemost 1996; 75: 432–436.
 
6. Chuansumrit A, Treepongkaruna S, Phuapradit P. Combined fresh frozen plasma with recombinant factor VIIa in restoring hemostasis for invasive procedures in children with liver diseases. Thromb Haemost 2001; 85: 748–749(letter).
 
7. Kalicinski P, Kaminski A, Drewniak T, et al. Quick correction of hemostasis in two patients with fulminant liver failure undergoing liver transplantation by recombinant activated factor VII. Transplant Proc 1999; 31: 378–379.
 
8. Al Douri M, Shafi T, Al Khudairi D, et al. Effect of the administration of recombinant activated factor VII (rFVIIa; NovoSeven) in the management of severe uncontrolled bleeding in patients undergoing heart valve replacement surgery. Blood Coagul Fibrinolysis 2000; 11 (Suppl 1): S121–S127.
 
9. Kenet G. rFVIIa for profuse bleeding in surgical patients. Bloodline Rev 2001;1:12–13. Available at: http://www.privatelectureseries.com/stories/storyReader$45. Accessed: November 19, 2002.
 
10. Tobias JD. Synthetic factor VIIa to treat dilutional coagulopathy during posterior spinal fusion in two children. Anesthesiology 2002; 96: 1522–1525.
 
11. Tobias JD, Berkenbosch JW, Muruve NA, Schmaltz RA. Correction of a coagulopathy using recombinant factor VII before removal of an intra-aortic balloon pump. J Cardiothorac Vasc Anesth 2002; 16: 612–614.
 
12. Tobias JD, Berkenbosch JW, Russo P. Recombinant factor VIIa to treat bleeding following cardiac surgery in an infant. Pediatr Crit Care Med 2003; 4: 49–51.
 
13. Cote CJ, Drop LJ, Hoaglin DC, Daniels AL, Young ET. Ionized hypocalcemia after fresh frozen plasma administration to thermally injured children. Anesth Analg 1988; 67: 152–160.
 
14. Hashim SW, Kay HR, Hammond GL, Kopf GS, Geha AS. Noncardiogenic pulmonary edema after cardiopulmonary bypass: An anaphylactoid reaction to fresh frozen plasma. Am J Surg 1984; 147: 560–564.
 
15. Bernstein DE, Jeffers L, Erhardtsen E, et al. Recombinant factor VIIa corrects prothrombin time in cirrhotic patients: A preliminary study. Gastroenterology 1997; 113: 1930–1937.
 
16. Poon MC, Demers C, Jobin F, Wu JWY. Recombinant factor VIIa is effective for bleeding and surgery in patients with Glanzmann thrombasthenia. Blood 1999; 94: 3951–3953.
 
17. Kristensen J, Killander A, Hippe E, et al. Clinical experience with recombinant factor VIIa in patients with thrombocytopenia. Haemostasis 1996; 26 (Suppl 1): 159–164.