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

ISRCTN	ISRCTN47341677
DOI	https://doi.org/10.1186/ISRCTN47341677
ClinicalTrials.gov (NCT)	NCT00650858
Protocol serial number	8523-072004
Sponsor	Johns Hopkins University (USA)
Funders	FDA Office of Orphan Products Development, Genentech

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

Contact information

Dr Daniel Hanley
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	CLEAR IVH: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)
Study acronym	CLEAR IVH
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. 30-day mortality 2. Incidence of ventriculitis, meningitis 3. Rate of bleeding events
Key secondary outcome measure(s)	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)
Completion date	30/04/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	64
Key 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
Key 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
Date of first enrolment	01/02/2004
Date of final enrolment	30/04/2007

Locations

Countries of recruitment

United States of America

Study participating centre

Johns Hopkins University

Baltimore, Maryland
21287
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Basic results				No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/04/2019: Publication reference added.