Tissue Plasminogen Activator for Intracerebral Hemorrhage

JR
Overseen ByJennifer R Isaacs, MS, MS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: David Dornbos
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using Tissue Plasminogen Activator (tPA) for individuals with intracerebral hemorrhage. Researchers aim to determine if a continuous flow of tPA into the brain clears blood and improves recovery more effectively than administering tPA every 8 hours or using a standard fluid. Individuals with this type of brain bleed who require an external ventricular drain (EVD) might be suitable candidates for the trial. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that a medication called Tissue Plasminogen Activator (tPA) can sometimes cause bleeding in the brain. In studies with stroke patients, about 8% experienced some type of brain bleeding, and around 3% had fatal bleeding. However, these studies also indicate that most people do not experience serious side effects from tPA. It is important to note that the FDA has already approved tPA for treating strokes, which means it is generally considered safe when used correctly. Always discuss the risks and benefits with a doctor before joining a clinical trial.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for intracerebral hemorrhage, which typically focus on managing symptoms and preventing complications, the use of Tissue Plasminogen Activator (tPA) aims to directly dissolve the blood clot in the brain. This approach is exciting because tPA, already known for its clot-busting capabilities in stroke patients, is now being evaluated for its ability to actively reduce the size of brain hemorrhages, potentially improving patient outcomes. Additionally, combining tPA with isotonic solution irrigation could enhance its effectiveness, providing a new avenue for treatment that addresses the underlying hemorrhage more directly than current therapies. Researchers are eager to explore whether this combination can lead to faster recovery and improved neurological function compared to standard care.

What evidence suggests that this trial's treatments could be effective for intracerebral hemorrhage?

This trial will compare Tissue Plasminogen Activator (tPA) with isotonic solution irrigation for intracerebral hemorrhage. Research has shown that tPA can improve recovery in stroke patients, with studies finding a 7.2% higher chance of excellent recovery after 90 days compared to those who do not receive it. However, tPA can also increase the risk of brain bleeding. Despite this risk, many patients find the benefits of tPA for strokes outweigh the risks. This treatment is already used for other types of strokes, and this study aims to determine its effectiveness for brain bleeds. Participants in this trial may receive isotonic solution irrigation alone or combined with tPA infusion.14678

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older who have bleeding into the brain's ventricles (intraventricular hemorrhage) that requires a drainage tube. Participants must have had little or no disability before the bleed and be able to give consent.

Inclusion Criteria

Consenting requirements met as outlined below
I am 18 years old or older.
I have had a brain bleed that required a drain to be placed.
See 1 more

Exclusion Criteria

Inability to initiate treatment within 24 hours of presentation
Incarcerated individuals, pregnant individuals, or other conditions as deemed by the investigator to potentially confound study data
I have bleeding in my brain caused by an injury.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either isotonic solution irrigation or isotonic solution irrigation with continuous TPA infusion

10 days
Daily monitoring with head CT scans

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of functional outcomes and other clinical measures

90 days
Regular follow-up visits as per clinical protocol

What Are the Treatments Tested in This Trial?

Interventions

  • Isotonic Solution
  • Tissue Plasminogen Activator (tPA)

Trial Overview

The study compares two ways of clearing blood from the brain: continuous tPA medication delivered through a drain versus continuous irrigation with a saltwater solution. The goal is to see which method works better for recovery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Isotonic solution irrigation + TPA InfusionExperimental Treatment1 Intervention
Group II: Isotonic solution irrigationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

David Dornbos

Lead Sponsor

Citations

Intracranial hemorrhage after recombinant tissue ...

Of the 241 patients with acute ischemic stroke who received rt-PA, the outcome of asICH occurred in 8.3 % of cases, which is more frequent than the occurrence ...

Intracerebral Hemorrhage After Intravenous t-PA Therapy ...

Results Overall, t-PA–treated patients had an increase in the absolute risk of symptomatic intracerebral hemorrhage of 6% and a decrease in the absolute risk of ...

Efficacy and safety of tissue plasminogen activator 3 to 4.5 ...

Compared to placebo treated patients, tPA treated patients experienced a 7.2% absolute increase in the rate of excellent recovery at 90-day follow-up (p=0.04).

Tissue Plasminogen Activator (tPA) For Acute Ischemic ...

The authors report a 3.2% improvement in good neurologic outcome, a 5.4% increase in symptomatic intracranial hemorrhage, and a 2.5% increase in mortality.

Different Doses of Intravenous Tissue-Type Plasminogen ...

This study aims to assess the efficacy and safety of different doses of intravenous tissue-type plasminogen activator (tPA) for acute ischemic stroke (AIS)

Intracranial Hemorrhage After Reperfusion Therapies in Acute ...

Fatal ICH occurred in 2.3% of patients receiving IV tPA beyond 4.5 h (32) and 2.6% receiving IV tPA from 0 to 4.5 h (39). Despite indirect comparisons between ...

Risk of Intracranial Hemorrhage Following Intravenous tPA ...

Regardless of prior assumption, there is at least a 98% chance that the risk is <15% and at least a 93% chance that the risk is <10%. These ...

Safety Outcomes of Thrombolysis for Acute Ischemic Stroke ...

In a large sample of patients admitted with AIS who received IV-tPA, history of ICH was independently associated with significantly increased mortality.