drugset / Trial / NCT05491356
Use of Tissue Plasminogen Activator in the Clearance of Chronic Subdural Hematomas
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To determine the utility of tissue plasminogen activator (tPA) in the clearance of chronic subdural hematomas (CSDH). Intra-catheter tPA will be administered during surgical procedure and allowed to break down blood clot to assist with removal/drainage during twist drill craniostomy procedure.
Timeline
- Start
- 2023-05-11
- Primary completion
- 2024-03-30
- Completion
- 2024-05-30
Publications
- Background Neils DM, Singanallur PS, Wang H, Tracy P, Klopfenstein J, Dinh D, Elwood PW, Fassett D, McCall T, Lin J, Tsung A. Recurrence-free chronic subdural hematomas: a retrospective analysis of the instillation of tissue plasminogen activator in addition to twist drill or burr hole drainage in the treatment of chronic subdural hematomas. World Neurosurg. 2012 Jul;78(1-2):145-9. doi: 10.1016/j.wneu.2011.08.032. Epub 2011 Nov 7.
- Background Brazdzionis J, Patchana T, Wiginton JG 4th, Wacker MR, Menoni R, Miulli DE. Intracatheter Tissue Plasminogen Activator for Chronic Subdural Hematomas after Failed Bedside Twist Drill Craniostomy: A Retrospective Review. Cureus. 2019 Dec 26;11(12):e6472. doi: 10.7759/cureus.6472.
- Background O YM, Tsang SL, Leung GK. Fibrinolytic-Facilitated Chronic Subdural Hematoma Drainage-A Systematic Review. World Neurosurg. 2021 Jun;150:e408-e419. doi: 10.1016/j.wneu.2021.03.029. Epub 2021 Mar 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alteplase | Protein / enzyme biologic | 1 mg/ml | Other |