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AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis

ConditionsIntraventricular HemorrhageSubarachnoid HemorrhageSubdural HematomaVentriculitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University

About this trial

The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD).

Subjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years of age

Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis

Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis

Signed informed consent obtained by subject or Legally Authorized Representative

Disqualifiers

Subject has fixed and dilated pupils

Pregnant women

Presence of Moyamoya

History or presence of clotting disorder.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IRRAflow with Active Fluid Exchange System

    Device

    IRRAflow® Active Fluid Exchange System is an intracranial drainage system intended for use by professional medical hospital personnel, trained and experienced in neurosurgical medical care. The intracranial pressure is kept at a safe level by draining excessive intracranial fluid. The system incorporates an irrigation support mechanism, used to irrigate the system in a controlled, programmed manner to minimize catheter occlusion. Additionally, a manual bolus can be given to facilitate keeping the catheter clear of occlusion or to clear the catheter of occlusion if one is present. This mechanism works by producing a bolus pulse using short periods of high flow (i.e. flow pulses).

  • External Ventricular Drain

    Device

    The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: IRRAflow with Active Fluid Exchange System (IRRAflow)Experimental treatment 1 intervention
Group B: External Ventricular Drainage (EVD)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of revision procedures for the IRRAflow and EVD/Drainage catheters

Time frame
Immediately post-procedure

Secondary outcomes

1

Time to clearance of blood or bacterial mass as measured by head CT scan

Time frame
Immediately post-procedure
2

Rate of catheter-related infection

Time frame
Immediately post-procedure
3

Length of ICU stay

Time frame
Baseline
4

Rate of shunt dependency

Time frame
Immediately post-procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

IRRAS

Collaborator

Source ClinicalTrials.gov
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