Stroke, Acute Clinical Trial
Official title:
Dynamic Decompressive Craniotomy
NCT number | NCT05051488 |
Other study ID # | 1 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 30, 2022 |
Est. completion date | December 30, 2023 |
Verified date | April 2022 |
Source | NeuroVention, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective observational study on patients undergoing decompressive craniotomy
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from a malignant stroke - Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from traumatic brain injury - Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from brain tumors. Exclusion Criteria: - Patients with blown pupil (cerebral herniation), - Massive brain swelling - Dismal outcome not expected to survive more than 1-2 weeks. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rohit Khanna, MD | Halifax Health |
Khanna R, Ferrara L, Khanna S. Biomechanics of a novel reversibly expandable dynamic craniotomy bone flap fixation plate. J Neurosurg. 2019 Jan 4;132(2):560-567. doi: 10.3171/2018.8.JNS172614. — View Citation
Khanna R, Ferrara L. Dynamic telescopic craniotomy: a cadaveric study of a novel device and technique. J Neurosurg. 2016 Sep;125(3):674-82. doi: 10.3171/2015.6.JNS15706. Epub 2015 Dec 11. — View Citation
Khanna R. Dynamic Decompressive Craniotomy with a Novel Reversibly Expandable Plate. J Neurol Surg A Cent Eur Neurosurg. 2017 Jul;78(4):386-389. doi: 10.1055/s-0036-1594013. Epub 2016 Nov 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical outcome | Modified Rankin Scale and Glasgow Outcome Score | 6 months | |
Primary | Craniotomy bone flap healing | CT scan to assess rate of normal bone flap position | 3 months |
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