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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.
A chronic subdural hematoma (CSDH) is a collection of blood overlying the brain that can be seen, usually in the elderly with even minimal head trauma. These are usually treated by removing the collection of blood. This can be done through a small drill hole in the skull or by larger holes (one or two) the size of a nickel. Sometimes a larger piece of skull is removed to be able to remove the CSDH. The standard practice at our center is to do these procedures under local anesthesia with a twist drill craniostomy (small drill hole through the skull). In some cases, all the CSDH can not be removed the first time, requiring a second procedure or a larger procedure. This study plans to use a type of medication that breaks down the solid blood clot, enabling more of it to drain. This medication (tpa) is already used in other surgeries and is safe to use in humans. Our preliminary experience and that of others suggests very low risk at the dosages being used. We hope that using this new drug will decrease the chance of the CSDH collecting again and reduce the overall length of your stay in the hospital and reduce the need for further surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - tPA administered | Experimental | This group will receive 2mL of intra-catheter tPA during twist drill craniostomy procedure |
|
| Placebo Control | Placebo Comparator | This group will receive 2mL of intra-catheter saline solution during twist drill craniostomy procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tissue Plasminogen Activator | Drug | Dosage of 1mg/mL mixed in 0.9% saline solution, intra-catheter administration, sterile |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study Feasibility | Patient recruitment rate, eligibility of patients, protocol adherence, unexpected events | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation rate | Reoperation rate or reintervention in the first 6 weeks post drainage | 8 months |
| Volume of chronic subdural hematoma | Volume, as measured in 3 intervals: pre-procedure, post-procedure at 24hrs and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Kesava Reddy | Hamilton Health Sciences Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22120294 | 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. | |
| 32025399 |
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Patient data will be de-identified and the data will be analyzed as a whole before becoming available to other researchers.
De-identified IPD may be shared with other researchers if necessary based on occurrence of adverse events occurrence, circumstantial findings, etc.
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| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Placebo | Drug | 0.9% saline solution, intra-catheter administration, sterile |
|
| 8 months |
| Rate of adverse events | Rate of adverse events in the first 6 weeks post procedure, including CNS infection, seizure, post-op hemorrhage | 8 months |
| Length of hospital stay | length of hospital stay in days | 8 months |
| 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. |
| 33722722 | 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. |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006406 | Hematoma |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |