Condition category
Circulatory System
Date applied
16/07/2004
Date assigned
23/09/2004
Last edited
23/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.neuro.jhmi.edu/ivh

Contact information

Type

Scientific

Primary contact

Dr Daniel Hanley

ORCID ID

Contact details

600 N. Wolfe Street
Jefferson 1-109
Baltimore
Maryland
21287
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00650858

Protocol/serial number

8523-072004

Study information

Scientific title

CLEAR IVH: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)

Acronym

CLEAR IVH

Study hypothesis

The specific objective of this trial is to determine the lowest dose possible with the best pharmacokinetic and safety profile and its ability to remove blood clot from the ventricular system

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Intraventricular hemorrhage

Intervention

Stage 1: patients received intraventricular injections of either 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to eight doses
Stage 2: patients will receive 1.0 mg every 8, 6, or 4 hours depending on the dose tier open at the time of enrollment

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. 30-day mortality
2. Incidence of ventriculitis, meningitis
3. Rate of bleeding events

Secondary outcome measures

1. Rate of clot size reduction at Days 4-5 determined by CT scans (stages 1 and 2)
2. 90 & 180 day GOS, Rankin, Stroke Impact Scale (stage 2 only)

Overall trial start date

01/02/2004

Overall trial end date

30/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-75
2. Intraventricular catheter (IVC) placed as standard of care using less than or equal to two complete passes
3. Spontaneous intracerebral hemorrhage (ICH) <30 cc
4. Able to receive first dose within 48 hours of computed tomography (CT) scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours)
5. Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size + 5 cc (as determined by the (A x B x C)/2 method)
6. On stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of cerebrospinal fluid [CSF] flow on CT)
7. Systolic
blood pressure (SBP) <200 mmHg sustained for 6 hours
8. Historical Rankin of 0 or 1

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Stage 1 complete (n = 16); Stage 2 open (n = 36-48)

Participant exclusion criteria

1. Suspected or untreated aneurysm or arterio venous malformation (AVM) (unless ruled out by angiogram or magnetic resonance angiography [MRA]/magnetic resonance imaging [MRI])
2. Clotting disorders
3. Patients with platelet count <100,000, international normalized ratio (INR) >1.7, prothrombin time (PT) >15 s, or an elevated activated partial thromboplastin time (APTT)
4. Pregnancy (positive pregnancy test)
5. Infratentorial hemorrhage (i.e. parenchymal/posterior fossa hematoma; all cerebellar hematomas are excluded)
6. Subarachnoid hemorrhage (SAH). (An angiogram should be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. If the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study.)
7. ICH enlargement during the 6-hour stabilization period (6 hours after IVC placement)
8. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
9. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g. venous cutdowns, arterial punctures) or site of recent surgical intervention
10. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis
11. Prior enrollment in the study
12. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
13. Participation in another simultaneous medical investigation or trial

Recruitment start date

01/02/2004

Recruitment end date

30/04/2007

Locations

Countries of recruitment

United States of America

Trial participating centre

Johns Hopkins University
Baltimore, Maryland
21287
United States of America

Sponsor information

Organisation

Johns Hopkins University (USA)

Sponsor details

600 N. Wolfe Street
Jefferson 1-109
Baltimore
Maryland
21287
United States of America

Sponsor type

University/education

Website

http://www.neuro.jhmi.edu/ivh

Funders

Funder type

Industry

Funder name

FDA Office of Orphan Products Development

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Genentech

Alternative name(s)

Genentech, Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00650858

Publication summary

Publication citations

Additional files

Editorial Notes