Legal and ethic rationales of including patients unable to consent into clinical trials;Ethische und juristische aspekte beim einschluss nicht einwilligungsfä higer patienten in akuttherapie-studien: Beispiel einer arzneimittelstudie zur behandlung intrazerebraler blutungen - Das heidelberger verfahren

Deutsche Medizinische Wochenschrift

Volumn 133, Issue 15, 2008, Pages 787-792

  Steiner, Thorsten ^a,b   Walter Sack, I ^a   Taupitz, J ^a   Hacke, W ^a   Strowitzki, T ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

Author keywords

Acute clinical trials; German drug law; Institutional review board applications; Intracerebral hemorrhage; Stroke

Indexed keywords

BLOOD CLOTTING FACTOR 7A; PLACEBO; RECOMBINANT PROTEIN; RECOMBINANT FVIIA; UNCLASSIFIED DRUG;

CLINICAL PRACTICE; CLINICAL STUDY; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; MEDICOLEGAL ASPECT; PROGNOSIS; PROSPECTIVE STUDY; RANKIN SCALE; REVIEW; RISK FACTOR; THROMBOEMBOLISM; BRAIN HEMORRHAGE; CUSTODY; EMERGENCY; ETHICS; GERMANY; LEGAL ASPECT; MENTAL CAPACITY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; TIME;

CEREBRAL HEMORRHAGE; CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; EMERGENCIES; ETHICS COMMITTEES, RESEARCH; FACTOR VIIA; GERMANY; HUMANS; INFORMED CONSENT; LEGAL GUARDIANS; MENTAL COMPETENCY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOMBINANT PROTEINS; RISK ASSESSMENT; TIME FACTORS;

EID: 41949120124     PISSN: 00120472     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-2008-1075648     Document Type: Review

References (26)

1. Richtlinie 2001/20/EG des Europäischen Parlamentes und des Rates vom 4. April 2001 zur Angleichung der Rechts- und Verwaltungsvorschriften der Mitgliedstaaten über die Anwendung der guten klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Humanarzneimitteln. Amtsblatt der Europäischen Gemeinschaften ABI EG 2001; L121: 34-44
2. Anderson CS, Chakera TM, Stewart-Wynne EG et al. Spectrum of primary intracerebral haemorrhage in Perth, Western Australia, 1989-90: incidence and outcome. J Neurol Neurosurg Psychiatry 1994; 57: 936-940
3. Broderick JP, Brott T, Tomsick T et al. Intracerebral hemorrhage more than twice as common as subarachnoid hemorrhage. J Neurosurg 1993; 78: 188-191
4. Brott T, Broderick J, Kothari R et al. Early hemorrhage growth in patients with intracerebral hemorrhage. Stroke 1997; 28: 1-5
5. Brott T, Hennes H. Intracerebral hemorrhage and progression.In: Steiner T, Hacke W, Hanley D eds (Hrsg). Update in Intensive Care and Emergency Medicine: Stroke. Berlin, Heidelberg, New York: Springer-Verlag, 1998: 128-132
6. Bundesgesetzblatt. 2005; I: 3394-
7. Counsell C, Boonyakarnkul S, Dennis M et al. Primary intracerebral haemorrhage in the Oxfordshire community stroke project, 2: prognosis. Cerebrovasc Dis 1995; 5: 26-34
8. Fujii Y, Tanaka R, Takeuchi S et al. Hematoma enlargement in spontaneous intracerebral hemorrhage. J Neurosurg 1994; 80: 51-57
9. Fujitsu K, Muramoto M, Ikeda Y et al. Indications for surgical treatment of putaminal hemorrhage. Comparative study based on serial CT and time-course analysis. J Neurosurg 1990; 73: 518-525
10. Habermann E, Lasch H, Gödicke P. Therapeutische Prüfung an Nicht-Einwilligungsfähigen im Eilfall - ethisch geboten und rechtlich zulässig? NJW 2000; 46: 3389-3395
11. Hacke W, Albers G, Al-Rawi Y et al. The Desmoteplase in Acute Ischemic Stroke Trial (DIAS): a phase II MRI-based 9-hour window acute stroke thrombolysis trial with intravenous desmoteplase. Stroke 2005; 36: 66-73
12. Hacke W, Donnan G, Fieschi C et al. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet 2004; 363: 768-774
13. Hacke W, Kaste M, Fieschi C et al. Intravenous thrombolysis with recombinant tissue plasminogen activator for acute hemispheric stroke, The European Cooperative Acute Stroke Study (ECASS). JAMA 1995; 274: 1017-1025
14. Hacke W, Kaste M, Fieschi C et al. Randomized, double-blind, placebo-controlled trial of thrombolytic therapy with intravenous recombinant tissue plasminogen activator in patients with acute ischaemic stroke. Results of the second European-Australian Acute Stroke Study (ECAS II). Lancet 1998; 352: 1245-1251
15. Kazui S, Naritomi H, Yamamoto H et al. Enlargement of spontaneous intracerebral hemorrhage. Incidence and time course. Stroke 1996; 27: 1783-1787
16. Kolominsky-Rabas PL, Sarti C, Heuschmann PU et al. A prospective community-based study of stroke in Germany - the Erlangen Stroke Project (ESPro): incidence and case fatality at 1, 3, and 12 months. Stroke 1998; 29: 2501-2506
17. Mayer S, Brun N, Broderick J et al. Recombinant activated factor VII for acute intracerebral hemorrhage: U.S. phase IIA trial. Neuricrit Care 2006; 4: 206-214
18. Mayer S, Brun N, Broderick J et al. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 2005; 352: 777-785
19. Mayer S, Brun N, Broderick J et al. Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke 2005; 36: 74-79
20. Rittner C. Ein Modell für die Forschung am einwilligungsunfähigen (bewusstlosen) Notfallpatienten. MedR 2007; 25: 340-344
21. Sacco RL, Boden-Albala B, Gan R et al. Stroke incidence among white, black, and Hispanic residents of an urban community: the Northern Manhattan Stroke Study. Am J Epidemiol 1998; 147: 259-268
22. Sjöblom L, Hardemark HG, Lindgren A et al. Management and prognostic features of intracerebral hemorrhage during anticoagulant therapy: a Swedish multicenter study. Stroke 2001; 32: 2567-2574
23. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med 1995; 333: 1581-1587
24. Tuhrim S, Horowitz DR, Sacher M et al. Volume of ventricular blood is an important determinant of outcome in supratentorial intracerebral hemorrhage. Crit Care Med 1999; 27: 617-621
25. Weimar C, Weber C, Wagner M et al. Management patterns and health care use after intracerebral hemorrhage. A cost-of-illness study from a societal perspective in Germany. Cerebrovasc Dis 2003; 15: 29-36
26. Weismüller K, Corvinus U, Röhrig R. Patienteninformationen und Einwilligungserklärungen" für primär nicht einwilligungsfähige Patienten TMF-Projekt Nr. V017-03_PEW_Trauma (AG DS), Sichtungsphase - Ein Projekt für die vernetzte medizinische Forschung im Namen der TMF. 2006