An interventional study of Early neurosurgical hematoma evacuation and Conservative treatment (best medical management) in Intracranial Hemorrhages and Surgery, sponsored by Leiden University Medical Center. Withdrawn at 1 site in Netherlands. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Treatment
Rationale: The rapidly increasing number of elderly (≥ 65 years old) with traumatic brain injury (TBI) is accompanied by substantial medical and economic consequences. An intracranial hematoma, specifically an acute subdural hematoma (ASDH), is the most common injury in elderly with TBI. The surgical versus conservative treatment of this patient group remains an important clinical and moral dilemma, since it is in most cases unclear which treatment leads to a better outcome for the patient. Current guidelines are not based on high-quality evidence and compliance is low, allowing for large treatment variation in both Belgium and the Netherlands for patients with a traumatic ASDH. In addition, elderly are underrepresented in scientific TBI literature and are therefore not included in current guidelines or prognostic models, leading to major uncertainty in (neurosurgical) decision-making for this group. As participants in two large TBI research projects (CENTER-TBI, Net-QuRe), the investigators observe that the uncertainty regarding treatment of elderly with a traumatic ASDH will not be solved by the current ongoing studies. Therefore, they recognize the necessity of undertaking a prospective, randomized, multicenter trial on the (cost-)effectiveness of early surgical hematoma evacuation versus a conservative treatment in elderly with a traumatic ASDH.
Objective: To compare the (cost-)effectiveness of early surgical hematoma evacuation versus a conservative treatment in elderly patients with a traumatic ASDH.
Study design: A prospective, pragmatic, multicenter, randomized controlled trial (RCT).
Study population: Patients ≥ 65 years with at first presentation a GCS ≥ 9 and a traumatic ASDH >10 mm or a traumatic ASDH \<10 mm and a midline shift >5 mm, or a GCS \< 9 with a traumatic ASDH \<10 mm and a midline shift \<5 mm without extracranial explanations for the comatose state, for whom clinical equipoise exists regarding the preferred treatment.
Intervention: Patients are randomized to either early surgical hematoma evacuation (A) or conservative management on the ICU or the ward (B). In case of neurological deterioration during conservative management, delayed surgery can be performed. The exact neurosurgical technique will be left to the discretion of the surgeons.
Main study parameters/endpoints: Functional outcome after 1 year, expressed by the rating on the Extended Glasgow Outcome Scale (GOS-E) Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both treatment strategies are already used in current clinical practice as standard medical care. Therefore, there are no extra risks for patients participating in the study compared to patients outside the study. Study participation adds a minimal burden of three follow-up evaluations by visit in the first year (at 3, 6 and 12 months) and subsequent yearly evaluations by phone or postal until five years after the injury. Future elderly patients with a traumatic ASDH will benefit mostly from this study's results.
211 studies on the registry are indexed under Intracranial Hemorrhages; 62 are open to participants now.
Browse Intracranial Hemorrhages studies →Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.
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The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Early neurosurgical hematoma evacuation
Other: Conservative treatment (best medical management)
Early neurosurgical hematoma evacuation (preferably within 2 hours)
Conservative treatment (best medical management) on the ICU or ward
Glasgow Outcome Scale Extended (GOS-E)
scale of functional outcome ranging from 1-8 in which a higher score reflects a better recovery
Time frame: 1 year
Plan to share: Undecided
This study is withdrawn, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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