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

ISRCTN ISRCTN47341677
DOI https://doi.org/10.1186/ISRCTN47341677
ClinicalTrials.gov number NCT00650858
Secondary identifying numbers 8523-072004
Submission date
16/07/2004
Registration date
23/09/2004
Last edited
11/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Daniel Hanley
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleCLEAR IVH: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)
Study acronymCLEAR IVH
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedIntraventricular hemorrhage
InterventionStage 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 typeOther
Primary outcome measure1. 30-day mortality
2. Incidence of ventriculitis, meningitis
3. Rate of bleeding events
Secondary outcome measures1. 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 study start date01/02/2004
Completion date30/04/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexAll
Target number of participantsStage 1 complete (n = 16); Stage 2 open (n = 36-48)
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/02/2004
Date of final enrolment30/04/2007

Locations

Countries of recruitment

  • United States of America

Study participating centre

Johns Hopkins University
Baltimore, Maryland
21287
United States of America

Sponsor information

Funders

Funder type

Industry

FDA Office of Orphan Products Development

No information available

Genentech
Government organisation / For-profit companies (industry)
Alternative name(s)
Genentech, Inc., Genentech USA, Inc., Genentech USA
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results No No
Results article results 01/05/2012 11/04/2019 Yes No
Results article results 01/06/2012 11/04/2019 Yes No
Results article results 01/06/2013 11/04/2019 Yes No
Results article results 01/09/2015 11/04/2019 Yes No
Results article results 01/03/2013 11/04/2019 Yes No
Results article results 01/12/2011 11/04/2019 Yes No

Editorial Notes

11/04/2019: Publication reference added.

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