Recombinant factor VIIa (rFVIIa): Its potential role as a hemostatic agent

Neuroradiology

Volumn 49, Issue 10, 2007, Pages 789-793

  Hedner, Ulla ^a,b   Brun, Nikolai C ^a  

^a LUND UNIVERSITY   (Sweden)

^b NOVO NORDISK A S   (Denmark)

Author keywords

Hemostasis; Intracerebral hemorrhage; Recombinant coagulation factor VIIa; Tissue factor

Indexed keywords

HEMOSTATIC AGENT; PHOSPHOLIPID; PLACEBO; RECOMBINANT BLOOD CLOTTING FACTOR 7A; THROMBOPLASTIN;

BLOOD CLOTTING DISORDER; BRAIN HEMORRHAGE; CELL MEMBRANE; CELL SURFACE; CLINICAL TRIAL; DRUG DOSE ESCALATION; DRUG MECHANISM; HEMOPHILIA; HEMOSTASIS; HUMAN; MOLECULAR MODEL; NEUROPROTECTION; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; REVIEW; SINGLE DRUG DOSE; THROMBOCYTE; THROMBOCYTE MEMBRANE; THROMBOCYTOPENIA; TREATMENT RESPONSE;

CEREBRAL HEMORRHAGE; CLINICAL TRIALS AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; FACTOR VII DEFICIENCY; FACTOR VIIA; HEMOPHILIA A; HEMOPHILIA B; HEMOSTATICS; INFUSIONS, INTRAVENOUS; RECOMBINANT PROTEINS; THROMBOPLASTIN;

EID: 34848838263     PISSN: 00283940     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00234-007-0240-2     Document Type: Review

References (43)

1. Davie EW, Ratnoff O (1964) Waterfall sequence for intrinsic blood clotting. Science 145:1310-1312
2. MacFarlane RG (1964) An enzyme cascade in the blood clotting mechanism, and its function as a biochemical amplifier. Nature 202:498-499
3. Rapaport SI, Rao LV (1992) Initiation and regulation of tissue factor-dependent blood coagulation. Arterioscler Thromb 12:1111-1121
4. Wildgoose P, Nemerson Y, Hansen LL, Nielsen EE, Glazer S, Hedner U (1992) Measurement of basal levels of factor VIIa in hemophilia A and B patients. Blood 80:25-28
5. Hedner U, Erhardtsen E (2003) Potential role of recombinant factor VIIa as a hemostatic agent. Clin Adv Hematol Oncol 1:112-119
6. Chen VM, Ahamed J, Versteeg HH, Berndt MC, Ruf W, Hogg PJ (2006) Evidence for activation of tissue factor by an allosteric disulfide bond. Biochemistry 45:12020-12028
7. Pendurthi UR, Ghosh S, Mandal S, Rao LVM (2006) Tissue factor activation: is disulfide switching a general regulatory mechanism? Blood (ASH Annual Meeting Abstracts) 108: Abstract 1747
8. Mandal SK, Pendurthi UR, Rao LVM (2007) Tissue factor trafficking in fibroblasts: involvement of protease activated receptor-mediated cell signaling. Blood. DOI 10.1182/blood-2006-10-050476
9. Konkle B, Friedrich U, Abrams Z (2006) Secondary prophylactic treatment with rFVIIa in patients with haemophilia A or B and inhibitors with high requirements for on-demand treatment. Poster presentation at the World Fed Haemophilia, Vancouver, Canada, May 2006. Haemophilia 12: Abstract 14 PO 363
10. Hedner U (2006) Potential role of recombinant factor FVIIa in prophylaxis in severe hemophilia patients with inhibitors. J Thromb Haemost 4:2498-2500
11. Bevers EM, Comfurius P, Zwaal RF (1991) Platelet procoagulant activity: physiological significance and mechanisms of exposure. Blood Rev 5:146-154
12. Monroe DM, Roberts HR, Hoffman M (1994) Platelet procoagulant complex assembly in a tissue factor-initiated system. Br J Haematol 88:364-371
13. Monroe DM, Hoffman M, Olivier JA, Roberts HR (1997) Platelet activity of high-dose factor VIIa is independent of tissue factor. Br J Haematol 99:642-647
14. Walsh PN (2004) Platelet coagulation-protein interactions. Semin Thromb Hemost 30:461-471
15. Monroe DM, Hoffman M, Roberts HR (2002) Platelets and thrombin generation. Arterioscler Thromb Vasc Biol 22:1381-1389
16. Hedner U (2006) Mechanism of action, development and clinical experience of recombinant FVIIa. J Biotechnol 124:747-757
17. He S, Jacobsson Ekman G, Hedner U (2005) The effect of platelets on fibrin gel structure formed in the presence of recombinant factor VIIa in hemophilia plasma and in plasma from a patient with Glanzmann thrombasthenia. J Thromb Haemost 3:272-279
18. Galán AM, Tonda R, Pino M, Reverter JC, Ordinas A, Escolar G (2003) Increased local procoagulant action: a mechanism contributing to the favorable hemostatic effect of recombinant FVIIa in PLT disorders. Transfusion 43:885-891
19. Kenet G, Walden R, Eldad A, Martinowitz U (1999) Treatment of traumatic bleeding with recombinant factor VIIa. Lancet 354:1879
20. Martinowitz U, Kenet G, Lubetski A, Luboshitz J, Segal E (2002) Possible role of recombinant activated factor VII (rFVIIa) in the control of hemorrhage associated with massive trauma. Can J Anaesth 49:S15-S20
21. Martinowitz U, Michaelson M; The Israeli Multidisciplinary rFVIIa Task Force (2005) Guidelines for the use of recombinant activated factor VII (rFVIIa) in uncontrolled bleeding: a report by the Israeli Multidisciplinary rFVIIa Task Force. J Thromb Haemost 3:640-648
22. Segal S, Shemesh IY, Blumental R, Yoffe B, Laufer N, Mankuta D, Mazor M, Zohar S, Schiff E, Martinovitz U (2004) The use of recombinant factor VIIa in severe postpartum hemorrhage. Acta Obstet Gynecol Scand 83:771-772
23. Grounds M (1995) Recombinant factor VIIa (rfVIIa) and its use in severe bleeding in surgery and trauma: a review. Blood Rev 17:S11-S21
24. Eikelboom JW, Bird R, Blythe D, Coyle L, Gan E, Harvey M, Isbister J, Leahy M, McIlroy D, Rahimpanah F, Ramanthan S, Strasser S, Ward C, Watts A, Towler S, Yi Q (2003) Recombinant activated factor VII for the treatment of life-threatening haemorrhage. Blood Coagul Fibrinolysis 14:713-717
25. Ahonen J, Jokela R (2005) Recombinant factor VIIa for life-threatening post-partum haemorrhage. Br J Anaesth 94:592-595
26. Boffard KD, Riou B, Warren B, Choong PI, Rizoli S, Rossaint R, Axelsen M, Kluger Y; NovoSeven Trauma Study Group (2005) Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma 59:8-18
27. Friederich PW, Henny CP, Messelink EJ, Geerdink MG, Keller T, Kurth KH, Büller HR, Levi M (2003) Effect of recombinant activated factor VII on perioperative blood loss in patients undergoing retropubic prostatectomy: a double-blind placebo-controlled randomised trial. Lancet 361:201-205
28. Astrup T (1991) Fibrinolysis: past and present, a reflection of fifty years. Semin Thromb Hemost 17:161-174
29. Andersson L (1964) Antifibrinolytic treatment with epsilon-aminocaproic acid in connection with prostatectomy. Acta Chir Scand 127:552-564
30. Andersson L (1974) Local fibrinolysis. In: Nilsson IM (ed) Haemorrhagic and thrombotic diseases. John Wiley & Sons, London, pp 155-182
31. Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators (2005) Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 352:777-785
32. Counsell C, Boonyakarnkul S, Dennis M, et al (1955) Primary intracerebral haemorrhage in the Oxfordshire Community Stroke Project. 2. Prognosis. Cerebrovasc Dis 5:26-34
33. Steiner T, Kaste M, Forsting M, Mendelow D, Kwiecinski H, Szikora I, Juvela S, Marchel A, Chapot R, Cognard C, Unterberg A, Hacke W (2006) Recommendations for the management of intracranial haemorrhage - Part 1: Spontaneous Intracerebral Haemorrhage The European Stroke Initiative Writing Committee and the Writing Committee for the EUSI Executive Committee. Cerebrovasc Dis 22:294-316
34. Mendelow AD, Gregson BA, Fernandes HM, Murray GD, Teasdale GM, Hope DT, Karimi A, Shaw MD, Barer DH; STICH investigators (2005) Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial. Lancet 365:387-397
35. Lyden PD, Shuaib A, Lees KR, et al (2007) Final results of CHANT: a study of the safety and tolerability of NXY-059 in intracerebral hemorrhage (abstract). Stroke 38:475
36. Brott T, Broderick J, Kothari R, et al (1997) Early hemorrhage growth in patients with intracerebral hemorrhage. Stroke 28:1-5
37. Davis SM, Broderick J, Hennerici M, Brun NC, Diringer MN, Mayer SA, Begtrup K, Steiner T; Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators (2006) Hematoma growth is a determinant of mortality and poor outcome after intracerebral hemorrhage. Neurology 66(8):1175-1181
38. Broderick JP, Diringer MN, Hill MD, Brun NC, Mayer SA, Steiner T, Skolnick BE, Davis SM (2007) Determinants of intracerebral hemorrhage growth: an exploratory analysis. Stroke 38:1072-1075
39. Steiner T, Diringer MN, Schneider D, Mayer SA, Begtrup K, Broderick J, Skolnick B, Davis SM (2006) Dynamics of intraventricular hemorrhage in patients with spontaneous intracerebral hemorrhage: risk factors, clinical impact, and effect of hemostatic therapy, with recombinant activated factor VII. Neurosurgery 59(4):767-773
40. Rice KM, Savidge GF (1996) Recombinant factor VIIa (r-FVIIa) in haemophilia management. Transfus Sci 17(3):339-340
41. Arkin S, Cooper HA, Hutter JJ, Miller S, Schmidt ML, Seibel NL, Shapiro A, Warrier I (1998) Activated recombinant human coagulation factor VII therapy for intracranial hemorrhage in patients with hemophilia A or B inhibitors. Results of the NovoSeven emergency-use program. Haemostasis 28:93-98
42. Mayer SA, Brun N, Broderick J, et al (2005) Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke 36:74-79
43. Mayer SA, Brun NC, Broderick J, Davis SM, Diringer MN, Skolnick BE, Steiner T; United States NovoSeven ICH Trial Investigators (2006) Recombinant activated factor VII for acute intracerebral hemorrhage. US phase IIa trial. Neurocrit Care 4:206-214