NCT00029315

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2002

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

March 25, 2015

Status Verified

December 1, 2001

First QC Date

January 10, 2002

Last Update Submit

March 24, 2015

Conditions

Cerebral Hemorrhage

Keywords

Intraventricular hemorrhageSubarachnoid hemorrhageIntracerebral hemorrhagePharmacokineticsRecombinant ProteinsAnticoagulantsTissue Plasminogen ActivatorPharmacologyCatheters, IndwellingCerebral Ventricles

Interventions

Recombinant Tissue Plasminogen Activator (rt-PA)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Cerebral HemorrhageSubarachnoid Hemorrhage

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2002

First Posted

January 11, 2002

Study Start

September 1, 2001

Study Completion

September 1, 2004

Last Updated

March 25, 2015

Record last verified: 2001-12

Locations

US(1)