Prospective studies in patients with intraventricular haemorrhage without the capacity to give consent in Germany--a legal dilemma.

Objective: The prognosis of intracranial haemorrhage with ventricular participation is poor. The acute onset of hydrocephalus has to be treated with an external ventricular drainage. However, intraventricular blood clots often obstruct the drainage catheter; the reinsertion is usually associated with an increased risk of complications. Therefore, intraventricular thrombolysis using recombinant tissue plasminogen activator (rt-PA), urokinase or streptokinase has been performed in several cases. In Germany, rt-PA does not have approval for intraventricular applications, and the risks and benefits of this treatment are as yet unclear. Several authors recommend its use only in the frame of prospective studies, meaning that intraventricular administration of thrombolytic agents within an individual therapy trial could be viewed as medical malpractice.

Methods: We designed a national prospective randomised and controlled study in patients with intraventricular haemorrhage to investigate the risks and effects of intraventricular rt-PA treatment. The local ethics committee and lawyers did not accept the study protocol due to a non-acceptable risk of complications. In two further conferences, the risk of undertreatment in the control group was a major reason not to accept the protocol. We discuss the conflicts of law in related studies.

Conclusions: There is a need for a solution to the legal conflicts of medical malpractice, unclear risk-benefit ratio and unfeasibility due to risk of complications or undertreatment in studies with patients without the capacity to give informed consent.