Use of Tissue Plasminogen Activator in the Clearance of Chronic Subdural Hematomas

NCT05491356 | Completed Phase 4

• 1 other identifier: 14724
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibrinolytic; Hemorrhage; Hematoma, Subdural

Outcome Measures

Primary Outcomes (1)

• Study Feasibility

  Patient recruitment rate, eligibility of patients, protocol adherence, unexpected events

  8 months

Secondary Outcomes (4)

• Reoperation rate

  8 months

• Volume of chronic subdural hematoma

  8 months

• Rate of adverse events

  8 months

• Length of hospital stay

  8 months

Study Arms (2)

Intervention - tPA administered

EXPERIMENTAL

This group will receive 2mL of intra-catheter tPA during twist drill craniostomy procedure

Drug: Tissue Plasminogen Activator

Placebo Control

PLACEBO COMPARATOR

This group will receive 2mL of intra-catheter saline solution during twist drill craniostomy procedure

Drug: Placebo

Interventions

Placebo DRUG

0.9% saline solution, intra-catheter administration, sterile

Placebo Control

Tissue Plasminogen Activator DRUG

Dosage of 1mg/mL mixed in 0.9% saline solution, intra-catheter administration, sterile

Intervention - tPA administered

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 yrs or older)
• Admitted to neurosurgery wing at the hospital
• Symptomatic patients requiring surgical drainage by twist drill craniostomy

You may not qualify if:

• Patients at increased risk of bleeding such as patients taking anticoagulation medication that required reversal at time of intervention، or those with coagulopathic disorder.
• Patients on antiplatelets or anticoagulation medications (DOACs or warfarin) with appropriate holding period prior to drainage, those who are eventually minimized to a regular bleeding risk compared to the normal population, will be included in the study.
• Patients with subdural empyema.
• Redo twist drill craniostomy for residual cSDH within the same admission.
• Drain accidentally removed during nursing care or patient transport before 24 hr interval scan.
• Patients who are not expected to live more than three months.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (3)

• 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.

  PMID: 22120294 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.

  PMID: 32025399 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.

  PMID: 33722722 BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural; Hemorrhage

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Hematoma; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Dr. Kesava Reddy

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: May 11, 2023
• Primary Completion: March 30, 2024
• Study Completion: May 30, 2024
• Last Updated: March 12, 2026

Record last verified: 2024-03

Locations

CA (1)