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Completed

NCT Number: NCT00029315

Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage

This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to dissolve blood, and may allow intraventricular catheters to be more effective for a longer period of time.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

About this study

IVH occurs in about 40 percent of intracerebral hemorrhage cases and 15 percent of aneurysmal subarachnoid hemorrhage cases. Evidence supports a strong contribution of IVH to morbidity and mortality after cerebral hemorrhage. External ventricular drainage (EVD) is required clinical management; however, EVD via intraventricular catheter alone fails to prevent much of the morbidity and mortality of IVH. This study seeks to demonstrate the safety and efficacy of intraventricular thrombolysis, using rt-PA, as a method of removing this blood and altering morbidity and mortality. Patients will receive intraventricular injections of rt-PA or placebo every 12 hours. They will be followed prospectively with daily head CT scans during the acute-treatment phase and again between Days 28 and 32.

Completion date provided represents the completion date of the grant per OOPD records

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Intraventricular hemorrhage (IVH) confirmed by CT scan
  • More than 12 hours post bleed
  • Hematoma size stable by CT scan
  • Post-IVH catheter CT scan
  • Able to begin study within 24 hours of bleed

Exclusion criteria

  • Infratentorial bleed
  • Supratentorial bleed greater than 30 cc
  • Unclipped aneurysm suspected
  • Arteriovenous malformation suspected
  • Any severe, complicating illness (e.g., AIDS or DNR)
  • Cardiovascular parameters that could confound study (e.g., myocardial infarction, pulmonary emboli, systemic fibrinolysis)
  • Active internal bleeding
  • Requirement for heparin doses greater than 10,000 U/day
  • Concurrent coumadin
  • Known allergy to rt-PA
  • Pregnancy

Treatment and study plan

Recombinant Tissue Plasminogen Activator (rt-PA)

Drug

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study

Important dates

Study start
2001
Study completion
2004
First posted
Jan 11, 2002
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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