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Thrombolytic Agent

Tissue Plasminogen Activator for Chronic Subdural Hematoma

Phase 4

Recruiting

Led By Dr. Kesava Reddy

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic patients requiring surgical drainage by twist drill craniostomy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 months

Awards & highlights

Study Summary

This trial will test whether tPA can help clear CSDH during surgery.

Who is the study for?

This trial is for adults over 18 who are admitted to the neurosurgery wing of a hospital and need surgery for chronic subdural hematomas. It's not for those who've had repeat surgeries, are on blood thinners without proper pause before surgery, have an infection in the hematoma, or if their drain was removed too soon.Check my eligibility

What is being tested?

The study tests whether tissue plasminogen activator (tPA), given through a catheter during surgery, can help clear out blood clots more effectively than a placebo during twist drill craniostomy procedures.See study design

What are the potential side effects?

Potential side effects of tPA may include bleeding complications, allergic reactions to the drug components, and possibly increased risk of infections at the surgical site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need surgery to relieve pressure in my skull.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Study Feasibility

Secondary outcome measures

Length of hospital stay

Rate of adverse events

Reoperation rate

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention - tPA administeredExperimental Treatment1 Intervention

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

Group II: Placebo ControlPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tissue Plasminogen Activator

1993

Completed Phase 2

~470

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,961 Total Patients Enrolled

Dr. Kesava ReddyPrincipal InvestigatorHamilton Health Sciences Corporation

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will the trial accept participants who are younger than 75 years old?

"This clinical trial admits participants aged between 18 and 100 years old. Additionally, there are 58 studies geared towards individuals under the age of 18, while 342 trials target people over 65."

Answered by AI

What potential risks could arise from administering Tissue Plasminogen Activator?

"The safety of Tissue Plasminogen Activator was deemed highly satisfactory, earning a score of 3 on our scale. This is because the drug has been approved following Phase 4 trials."

Answered by AI

To whom does this clinical trial extend an invitation?

"This clinical trial seeks 40 participants with hematoma, subdural aged between 18 and 100. Criteria for selection includes being an adult (18 years or more), admittance to the neurosurgery wing of a hospital, and displaying symptoms which demand surgical drainage by twist drill craniostomy."

Answered by AI

Are participants being enrolled in this experiment currently?

"Clinicaltrials.gov points to this trial not presently accepting new patients, with its initial posting on the 1st of September 2022 and last update occurring 4th August 2022. However, there are 417 other clinical trials that are in need of volunteers at present."

Answered by AI

Recent research and studies

CureusJournal

Intracatheter Tissue Plasminogen Activator for Chronic Subdural Hematomas After Failed Bedside Twist Drill Craniostomy: A Retrospective Review

Brazdzionis, James, Tye Patchana, James G Wiginton, Margaret Rose Wacker, Rosalinda Menoni, and Dan E Miulli. 2019. “Intracatheter Tissue Plasminogen Activator for Chronic Subdural Hematomas After Failed Bedside Twist Drill Craniostomy: A Retrospective Review”. Cureus. Cureus, Inc.. doi:10.7759/cureus.6472.

World NeurosurgeryJournal

Fibrinolytic-facilitated Chronic Subdural Hematoma Drainage—a Systematic Review

O, Yip Mang, Shek Long Tsang, and Gilberto Ka-Kit Leung. 2021. “Fibrinolytic-facilitated Chronic Subdural Hematoma Drainage—a Systematic Review”. World Neurosurgery. Elsevier BV. doi:10.1016/j.wneu.2021.03.029.

World NeurosurgeryJournal

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

Neils, David M., Pradeep S. Singanallur, Huaping Wang, Patrick Tracy, Jeffrey Klopfenstein, Dzung Dinh, Patrick W. Elwood, et al.. 2012. “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 Neurosurgery. Elsevier BV. doi:10.1016/j.wneu.2011.08.032.

clinicaltrials.govStudy