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
Not provided at time of registration
Contact information
Dr Daniel Hanley
Scientific
Scientific
600 N. Wolfe Street
Jefferson 1-109
Baltimore, Maryland
21287
United States of America
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | CLEAR IVH: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH) |
| Study 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(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | 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 study start date | 01/02/2004 |
| Overall study end date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | Stage 1 complete (n = 16); Stage 2 open (n = 36-48) |
| 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 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
Study participating centre
Johns Hopkins University
Baltimore, Maryland
21287
United States of America
21287
United States of America
Sponsor information
Johns Hopkins University (USA)
University/education
University/education
600 N. Wolfe Street
Jefferson 1-109
Baltimore, Maryland
21287
United States of America
| Website | http://www.neuro.jhmi.edu/ivh |
|---|---|
"ROR" |
https://ror.org/00za53h95 |
Funders
Funder type
Industry
FDA Office of Orphan Products Development
No information available
Genentech
Private sector organisation / For-profit companies (industry)
Private sector 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
