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| ID | Type | Description | Link |
|---|---|---|---|
| p-2024-17691 | Other Identifier | Privacy, Capital Region of Denmark |
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This observational study involving patients with acute brain injury undergoing treatment with an external ventricular drain consists of three subprojects, aiming to:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sampling of blood and cerebrospinal fluid | Other | As soon as possible after placement of the external drain, and then in intervals of 1-3 days;
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| Measure | Description | Time Frame |
|---|---|---|
| Concentration of cerebrospinal fluid lactate | in patients with compared to patients without positive CSF culture, and for b. patients with both a positive CSF culture and a distinct drop in the level of consciousness compared to patients with negative CSF culture and a stable level of consciousness. | Throughout the external ventricular drain duration (1-60 days) |
| Measure | Description | Time Frame |
|---|---|---|
| CSF lactate concentration change in patients developing ventriculostomy associated infection | Concentration of CSF lactate and other CSF markers a. before, during and after detection of organisms in patients with a positive CSF culture, and b. if no organisms are detected, during the first, second and third tertile of EVD treatment. | Throughout the external ventricular drain duration (1-60 days) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute brain injury, that are treated with an external ventricular drain
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pernille Nielsen, Medical doctor | Contact | +45 22220775 | pernille.nielsen.05@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
IPD will only be shared with a data sharing agreement
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| Functional outcome at six months | Functional outcome evaluated six months after the initial brain injury using: 1) modified Rankin Scale (mRS) as favourable (0-2) or unfavourable (3-6) | 6 months after the initial brain injury |
| Functional outcome at six months | Functional outcome evaluated six months after the initial brain injury using: 2) Glascow Outcome Score-Extended (GOS-E) as favorable (5-8) or unfavorable (0-4) | 6 months after the initial brain injury |
| Comparison of concentration of cerebrospinal fluid markers drawn from the proximal and distal port of the EVD | Mean difference, limits of agreement, intraclass correlation, mean of absolute difference and consistency between measurements of CSF markers drawn from the proximal and distal port of the EVD. | Throughout the external ventricular drain duration (1-60 days) |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |