Scientific and logistical challenges in designing the CONTROL trial: Recombinant factor VIIa in severe trauma patients with refractory bleeding

Clinical Trials

Volumn 6, Issue 5, 2009, Pages 467-479

  Dutton, Richard ^a,i   Hauser, Carl ^b   Boffard, Kenneth D ^c,o   Dimsitts, Jeannett ^d   Bernard, Gordon ^e   Holcomb, John ^f,k   Leppäniemi, Ari K ^g,p   Tortella, Bartholemew ^d   Bouillon, Bertil ^h   Croce, Martin A ^j   Vincent, Jean Louis ^l   Parr, Michael ^m,n  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^d NOVO NORDISK A S   (Denmark)

^e VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

^g Meilahti Hospital   (Finland)

^h UNIVERSITY OF WITTEN HERDECKE   (Germany)

ⁱ R ADAMS COWLEY SHOCK TRAUMA CENTER   (United States)

^j UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^k US ARMY INSTITUTE OF SURGICAL RESEARCH   (United States)

^l ERASME HOSPITAL   (Belgium)

^m Roy Liverpool Children's NHS T   (United Kingdom)

ⁿ UNIVERSITY OF NEW SOUTH WALES   (Australia)

^o UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^p UNIVERSITY OF HELSINKI   (Finland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT BLOOD CLOTTING FACTOR 7A;

ARTICLE; BLEEDING; BLUNT TRAUMA; CLINICAL RESEARCH; CLINICAL TRIAL; CONSCIOUSNESS LEVEL; CRITERION VARIABLE; DRUG EFFICACY; DRUG SAFETY; EMERGENCY TREATMENT; ERYTHROCYTE TRANSFUSION; EXPERIMENTAL DESIGN; HUMAN; INFORMED CONSENT; INTENSIVE CARE; MORTALITY; MULTICENTER STUDY; PENETRATING TRAUMA; PRACTICE GUIDELINE; PRIORITY JOURNAL; STANDARDIZATION; TRAUMATIC BLEEDING;

FACTOR VIIA; GUIDELINE ADHERENCE; HEMORRHAGE; HUMANS; INFORMED CONSENT; MULTICENTER STUDIES AS TOPIC; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT SELECTION; PRACTICE GUIDELINES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOMBINANT PROTEINS; RESEARCH DESIGN; TIME FACTORS; WOUNDS AND INJURIES;

EID: 71049192309     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774509344102     Document Type: Article

References (62)

1. Tsochatzis E., Papatheodoridis GV, Manesis EK et al. Prophylactic and therapeutic use of recombinant activated factor VII in patients with cirrhosis and coagulation impairment. Dig Liver Dis 2007; 39: 490-94.
2. Gala B., Quintela J., Aguirrezabalaga J. et al. Benefits of recombinant activated factor VII in complicated liver transplantation. Transplant Proc 2005; 37: 3919-21.
3. Poon MC, d'Oiron R. Recombinant activated factor VII (NovoSeven) treatment of platelet-related bleeding disorders. International Registry on Recombinant Factor VIIa and Congenital Platelet Disorders Group. Blood Coagul Fibrinolysis 2000; 11(Suppl1): S55-68.
4. Monroe DM, Hoffman M., Allen GA, Roberts HR The factor VII-platelet interplay: Effectiveness of recombinant factor VIIa in the treatment of bleeding in severe thrombocytopathia. Semin Thromb Hemost 2000; 26: 373-77.
5. Mayer SA Intracerebral hemorrhage: Natural history and rationale of ultra-early hemostatic therapy. Intensive Care Med 2002; 28(Suppl 2): S235-40.
6. Mohr AM, Holcomb JB, Dutton RP, Duranteau J. Recombinant activated factor VIIa and hemostasis in critical care: A focus on trauma. Crit Care 2005; 9(Suppl 5): S37-42.
7. Dutton RP, Hess JR, Scalea TM Recombinant factor VIIa for control of hemorrhage: Early experience in critically ill trauma patients. J Clin Anesth 2003; 15: 184-88.
8. Ranucci M., Isgrò G., Soro G. et al. Efficacy and safety of recombinant activated factor vii in major surgical procedures: systematic review and meta-analysis of randomized clinical trials. Arch Surg 2008; 143: 296-304, discussion 304.
9. Karkouti K., Beattie WS, Crowther MA et al. The role of recombinant factor VIIa in on-pump cardiac surgery: Proceedings of the Canadian Consensus Conference. Can J Anaesth 2007; 54: 573-82.
10. Spinella P., Perkins JG, McLaughlin DF et al. The effect of recombinant activated factor VII on mortality in combat-related casualties with severe trauma and massive transfusion. J Trauma 2008; 64: 286-93; discussion 293-94.
11. Boffard KD, Riou B., Warren B. et al. 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 2005; 59: 8-15; discussion 15-18.
12. Mayer SA, Brun NC, Begtrup K. et al. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 2005; 352: 777-85.
13. Mayer SA, Brun NC, Broderick J. et al. Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke 2005; 36: 74-79.
14. Mayer SA, Brun NC, Broderick J. et al. Recombinant activated factor VII for acute intracerebral hemorrhage: US phase IIA trial. Neurocrit Care 2006; 4: 206-14.
15. Shao YF, Yang JM, Chau GY et al. Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: A multicenter, randomized, double-blind, placebo-controlled trial. Am J Surg 2006; 191: 245-49.
16. Lodge JP, Jonas S., Jones RM et al. Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation. Liver Transpl 2005; 11: 973-79.
17. Bosch J., Thabut D., Bendtsen F. et al. Recombinant factor VIIa for upper gastrointestinal bleeding in patients with cirrhosis: A randomized, double-blind trial. Gastroenterology 2004; 127: 1123-30.
18. Mayer SA, Brun NC, Begtrup K. et al. FAST Trial Investigators. Efficacy and safety of recombinant factor VII for acute intracerebral hemorrhage. N Engl J Med 2008; 358: 2127-37.
19. Sauaia A., Moore FA, Moore EE et al. Epidemiology of trauma deaths: A reassessment. J Trauma 1995; 38: 185-93.
20. MacLeod JB, Lynn M., McKenney MG et al. Early coagulopathy predicts mortality in trauma. J Trauma 2003; 55: 39-44.
21. Spahn DR, Cerny V., Coats TJ et al. Management of bleeding following major trauma: A European guideline. Crit Care 2007; 11: R17.
22. Lynn M., Jeroukhimov I., Klein Y., Martinowitz U. Updates in the management of severe coagulopathy in trauma patients. Intensive Care Med 2002; 28(Suppl 2): S241-47.
23. Tieu BH, Holcomb JB, Schreiber MA Coagulopathy: Its pathophysiology and treatment in the injured patient. World J Surg 2007; 31: 1055-64.
24. Brohi K., Singh J., Heron M., Coats T. Acute traumatic coagulopathy. J Trauma 2003; 54: 1127-30.
25. Maegele M., Lefering R., Yucel N. et al. Early coagulopathy in multiple injury: An analysis from the German Trauma Registry on 8724 patients. Injury 2007; 38: 298-304.
26. Cosgriff N., Moore EE, Sauaia A. et al. Predicting life-threatening coagulopathy in the massively transfused trauma patient: Hypothermia and acidoses revisited. J Trauma 1997; 42: 857-61; discussion 861-62.
27. Kauvar DS, Lefering R., Wade CE Impact of hemorrhage on trauma outcome: an overview of epidemiology, clinical presentations, and therapeutic considerations. J Trauma 2006; 60(6 Suppl): S3-11.
28. Dutton RP Goals of therapy in common bleeding emergencies. Pharmacotherapy 2007; 27: 85S-92S.
29. Vincent JL, Rossaint R., Riou B. et al. Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding-a European perspective. Crit Care 2006; 10: R120.
30. Schreiber MA Damage control surgery. Crit Care Clin 2004; 20: 101-18.
31. Peden M. The Injury Chart Book: A Graphical Overview of the Global Burden of Injuries. World Health Organization, Geneva, 2002.
32. Murray CJ, Lopez AD Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study. Lancet 1997; 349: 1498-504.
33. Culica D., Aday LA Factors associated with hospital mortality in traumatic injuries: Incentive for trauma care integration. Public Health 2008; 122: 285-96.
34. Rotondo MF, Schwab CW, McGonigal MD et al. 'Damage control': An approach for improved survival in exsanguinating penetrating abdominal injury. J Trauma 1993; 35: 375-82; discussion 382-83.
35. Dutton RP, McCunn M., Hyder M. et al. Factor VIIa for correction of traumatic coagulopathy. J Trauma 2004; 57: 709-18; discussion 718-19.
36. Napolitano LM Current status of blood component therapy in surgical critical care. Curr Opin Crit Care 2004; 10: 311-17.
37. Napolitano LM Scope of the problem: Epidemiology of anemia and use of blood transfusions in critical care. Crit Care 2004; 8(Suppl 2): S1-8.
38. Napolitano LM, Corwin HL Efficacy of red blood cell transfusion in the critically ill. Crit Care Clin 2004; 20: 255-68.
39. Napolitano LM Perioperative anemia. Surg Clin North Am 2005; 85: 1215-27.
40. Napolitano L. Cumulative risks of early red blood cell transfusion. J Trauma 2006; 60(6 Suppl): S26-34.
41. Bernard GR Acute respiratory distress syndrome: A historical perspective. Am J Respir Crit Care Med 2005; 172: 798-806.
42. Van den Berghe GH Role of intravenous insulin therapy in critically ill patients. Endocr Pract 2004; 10(Suppl 2): 17-20.
43. Nathens AB, Brunet FP, Maier RV Development of trauma systems and effect on outcomes after injury. Lancet 2004; 363: 1794-801.
44. Serio JC, Tichner JB, Dilley ME State-by-State Clinical Trial Requirements Reference Guide. Barnett International Media, Waltham, MA, 2004.
45. Dutton RP, Stansbury LG, Hemlock B. et al. Impediments to obtaining informed consent for clinical research in trauma patients. J Trauma 2008; 64: 1106-12.
46. Tallon JM The 'golden hour' paradigm. Acad Emerg Med 2002; 9: 760; author reply 760.
47. Food and Drug Administration. CFR Title 21, Part 50.24 2007.
48. Dutton RP, Mackenzie CF, Scalea TM Hypotensive resuscitation during active hemorrhage: Impact on in-hospital mortality. J Trauma 2002; 52: 1141-6.
49. Food and Drug Administration. Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees. Food and Drug Administration, Rockville, MD, November 2006.
50. World Health Organization. Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards. World Health Organization, Geneva, March 2005.
51. European Medicines Agency. Guideline on Data Monitoring Committees. European Medicines Agency, London, July 2005.
52. Champion HR, Fingerhut A., Escobar MA, Weiskopf R. The role of data and safety monitoring in acute trauma research. J Am Coll Surg 2007; 204: 73-83.
53. DAMOCLES Study Group. NHS Health Technology Assessment Programme: A proposed charter for clinical trial data monitoring committees: Helping them to do their job well. Lancet 2005; 365: 711-22.
54. Grant AM, Altman DG, Babiker AB et al. Issues in data monitoring and interim analysis of trials (the DAMOCLES study). Health Technol Assess 2005; 9: 1-238.
55. Stein DM, Dutton RP, O'Connor J. et al. Determinants of futility of administration of recombinant factor VIIa in trauma. J Trauma 2005; 59: 609-15.
56. Moore FA, Nelson T., McKinley BA et al. Massive transfusion in trauma patients: Tissue hemoglobin oxygen saturation predicts poor outcome. J Trauma 2008; 64: 1010-23.
57. Klitgaard T., Tabanera y Palacios R., Boffard KD et al. Pharmacokinetics of recombinant activated factor VII in trauma patients with severe bleeding. Crit Care 2006; 10: R104.
58. Martinowitz U., Kenet G., Segal E. et al. Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma 2001; 51: 431-38; discussion 438-39.
59. Martinowitz U., Michaelson M. 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 2005; 3: 640-48.
60. Hébert PC Transfusion requirements in critical care (TRICC): A multicentre, randomized, controlled clinical study. Transfusion requirements in critical care investigators and the Canadian critical care trials group. Br J Anaesth 1998; 81(Suppl 1): 25-33.
61. Hébert PC, Fergusson DA, Stather D. et al. Revisiting transfusion practices in critically ill patients. Crit Care Med 2005; 33: 7-12.
62. Available at: www.ardsnet.org. (accessed 12 December 2008).