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Biomedical subjects

E J Kompanje

Publications and source records attributed to E J Kompanje.

5 recordsLinked to original sources

['The rumbling of shaking brains'; the treatment of traumatic skull and brain injury in the Netherlands in the 17th century: 7 case reports from Observationes medicae by Nicolaes Tulp].

In the 17th century, several collections of medical case reports were published in the Netherlands, mostly by surgeons. The often detailed descriptions provide a good impression of medical practice in those days. One of the best-known authors of such a collection of case reports is doctor Nicolaes Tulp (1593-1674). In the latest edition of his Observationes medicae (1739), 229 cases are described, seven of which pertain to traumatic skull and brain injury. These cases provide a clear picture of the treatment of traumatic brain injury in Amsterdam in the 17th century. The cases were caused by falling objects, a fall due to drunkenness, a gunshot wound and a fall on a slippery bridge. The frequency of surgical intervention in traumatic brain injury as reported by Tulp is remarkable; he describes frequent trepanation and craniectomy for epidural and acute subdural haematoma, coagulation of bleeding vessels on the dura, removal of contused brain tissue and the operative treatment of depressed skull fractures. It may be further concluded from the descriptions that Tulp adhered to a large extent to the medical views concerning the blood circulation as described by Galenus (129-199 AD).

Brain Injuries↗

[Clinical trials on medical products for human use in the case of acutely incapacitated patients within the fields of neurology and neurosurgery; implications of the new European legislation].

To comply with the European directive on clinical trials on medical products for human use, an amendment to the Dutch Medical Research Involving Human Beings Act was formally submitted in the Netherlands on the 27th February 2003. The objective is harmonisation of legislation and the protection of patients participating in clinical trials within the European Union. An important element of the directive is additional protection for incapacitated patients. In the fields of neurology and neurosurgery much research, mainly phase III, is conducted into the safety and efficacy of pharmaceutical products in emergency situations such as traumatic skull-brain injury or an acute cerebral infarct. Future emergency research in patients with acute cerebral disorders will be hindered by the (shortly legal) requirement that prior proxy consent is mandatory and the fact that individual patients must directly benefit as a result of their participation. This unintended negative effect may be considered contrary to the ethical principals for conducting good scientific research to improve treatment results. Also, it may lead to a scientific backlog compared to countries outside of the European Union. In the case of emergency phase-III research among acutely incapacitated patients we recommend that the Central Committee on Research Involving Human Subjects [Dutch acronym: CCMO] tests the research, that trials have an independent committee to monitor the data and safety, that an independent physician may grant consent for the patient to participate and that the consent of the patient's representative(s) is obtained within 24 hours of the patient being included in the trial.

Clinical Trials, Phase III as Topic↗