Cerebral Hemorrhage, Intraventricular Hemorrhage
Conditions
Keywords
Hemorrhage, Cerebral Hemorrhage, Intraventricular Hemorrhage
Brief summary
Study evaluating if active irrigation by IRRAflow® with infusion of tPA will reduce the time needed for clearance of intracerebral and intraventricular hemorrhage compared with passive drainage.
Detailed description
The ARCH study is an international prospective, controlled, randomized, multicenter study to evaluate the hypothesis that active irrigation with IRRAflow® will reduce the time needed for clearance of intraventricular and intracerebral blood from intraventricular and intracerebral space compared with passive drainage and administration of tPA. This might affect the patient neurological outcome assessed by GCS and mRankin scale.
Interventions
DEVICEIRRAflow
IRRAflow consists of a control unit and disposables (dual-lumen catheter and tube set) to offer an integrated and synchronized active fluid exchange system. Active fluid exchange is the combination of traditional gravity-driven drainage with periodic, controlled irrigation of the catheter probe to exchange any pathological fluid collection with neutral physiological fluids.
DEVICEEVD
An external ventricular drain (EVD), also known as a ventriculostomy or extraventricular drain, is a device used in neurosurgery to treat hydrocephalus and relieve elevated intracranial pressure when the normal flow of cerebrospinal fluid inside the brain is obstructed.
Sponsors
University of Helsinki
Northwestern University
West Virginia University
Klinikum Bergmannstrost
Stony Brook University Hospital
Icahn School of Medicine at Mount Sinai
Buffalo General Medical Center
IRRAS
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years of age 2. Need of EVD 3. Active treatment 4. Signed informed consent obtained a. Based on institutional and country laws 5. Spontaneous ICH with maximum 30 square cm's 6. If needed, normal coagulation profile (PT, PTT, platelet count) 7. Treatment within 72 hours of ictus 8. Ability to administer 2.0 mg of tPA per day for 3 days
Exclusion criteria
1. Age \< 18 years 2. No need of EVD 3. Patient has fixed and dilated pupils 4. Coagulopathy uncorrectable 5. Vascular pathology (e.g. Aneurysm involvement, AVM involvement) 6. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and safety of evacuation of intraventricular hematoma by Active External Ventricular Drainage (IRRAflow) with tPA administration compared to Passive External Ventricular Drainage (EVD) with tPA administration. | Intra-procedure | Efficacy is defined as the efficiency of each arm to remove the hematoma (70% cm3). Safety is measured as the frequency of bacterial central nervous system (measures as positive bacterial growth in cerebrospinal fluid), symptomatic brain bleeds (clinical symptoms drop in modified Rankin scale), and mortality (death). |
| Radiographic evaluation of ventricular blood removal as measured by head CT scan | Intra-procedure | Change in blood volume (cm3) measured between stability scan and end of treatment scan. |
| Comparison of patient outcome between groups at as measured by the Glasgow Coma Scale, extended Glasgow Outcome Scale, modified Rankin Scale. | 0-30 days post discharge from hospital | Defined as the comparison of patients outcomes between the three groups as measured by Glasgow Coma Scale, extended Glasgow Outcome Scale, and modified Rankin Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Bleeding events | Intra-Procedural | Comparison of new bleeding events on routine neuroimaging |
| Procedural Success | Intra-Procedural | Less than or equal to 30% residual clot burden in the ventricular system |
| Technical Success | Intra-Procedural | Percentage of patients in which correct placement of IRRAflow and EVD catheter occurred |
| Safety - Catheter misplacement | Intra-Procedural | Measurement of if the catheter needs to be re-inserted or re-positioned. |
| Safety - Infection | Intra-Procedural | Comparison of rate of infection as measured by routine cerebrospinal fluid (CSF) analysis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of EVD and IRRAflow catheter in place | Intra-Procedural | Number of days between catheter insertion and with drawl of the catheter |
| Rate of clot removal as assessed by CT | Intra-Procedural | Change in blood volume measured between stability scan and end of treatment scan |
| Duration of catheter drainage | Intra-Procedural | Number of days catheter was utilized for drainage |
| Catheter occlusion rate | Intra-Procedural | Percentage of time in which the catheter is unable to drain |
| Revision rate of the EVD and IRRAflow catheter | Intra-Procedural | Percentage of time that the physician must replace or manipulate the EVD or IRRAflow catheter |
| Repeat hemorrhagic events | Intra-Procedural | Number of repeated symptomatic hemorrhagic events |
| Catheter occlusion | Intra-Procedural | Number of flushes required to clear a catheter occlusion |
| Functional Status | Intra-Procedural | modified Rankin Score (mRS) |
| Total cost of procedure | Intra-Procedural | Measured as total cost involved in treating patient during treatment with IRRAflow and EVD |
| Rate of mortality during treatment | Intra-Procedural | Percentage of patients having a mortality event during active treatment |
| Length of ICU stay (days) | Intra-Procedural | Time (days) the patient is admitted to the ICU till the patient is discharged from the ICU |
| Length of overall length (days) of hospital stay | Intra-Procedural | Time (days) the patient is admitted to the hospital till the patient is discharged from the hospital |
| Rate of shunt dependency | 30 days | Percentage of patients that require a shunt after treatment |
| Radiological evaluation of ventricles as measured by CT scan of head | Intra-Procedural | Radiologic evaluation of the ventricles by the neurosurgeon or radiologist |
Countries
Finland
Contacts
Primary ContactJohn Unser, MBA
Outcome results
None listed