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

Subarachnoid Hemorrhage Clinical Trial

— AFFECT  

Official title:

Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649904
• Other study ID #: 2022H0197
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: January 2026

Study information

• Verified date: April 2023
• Source: Ohio State University
• Contact: Victoria Adams
• Phone: 6146854484
• Email: victoria.adams[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years of age

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

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

4. Signed informed consent obtained by subject or Legally Authorized Representative

Exclusion Criteria:

1. Subject has fixed and dilated pupils

2. Pregnant women

3. Presence of Moyamoya

4. History or presence of clotting disorder.

5. Platelet count less than 100,000, INR greater than 1.4

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hematoma
• Hemorrhage
• Intraventricular Hemorrhage
• Subarachnoid Hemorrhage
• Subdural Hematoma
• Ventriculitis

Intervention

Device:
• IRRAflow with Active Fluid Exchange System
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
The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	IRRAS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of revision procedures for the IRRAflow and EVD/Drainage catheters		Immediately post-procedure
Secondary	Time to clearance of blood or bacterial mass as measured by head CT scan		Immediately post-procedure
Secondary	Rate of catheter-related infection		Immediately post-procedure
Secondary	Length of ICU stay		Baseline
Secondary	Rate of shunt dependency		Immediately post-procedure
Secondary	Indwell time of EVD/Drainage and IRRAflow Catheter		Immediately post-procedure
Secondary	Functional Status - at inclusion and 30 days	The Modified Rankin Scale will be used to assess functional status. The Modified Rankin Scale ranges from 0 (no disability) to 6 (death).	30 days post subject discharge
Secondary	Mortality rates - intraprocedural and at 30 days		30 days post subject discharge
Secondary	Functional Status - at inclusion and 30 days	The Extended Glasgow Coma Scale will be used to assess functional status. Results range from 1 (death) to 8 (upper good recovery).	30 days post subject discharge
Secondary	Functional Status - at inclusion and 30 days	The Barthel Index will be used to assess functional status. Scores for this assessment tool range from 0 - 100, with a higher number indicating a better functional status.	30 days post subject discharge
Secondary	Functional Status - at inclusion and 30 days	The Stroke Impact Scale will be used to assess functional status. Scores for this scale range from 0 - 100, with a higher number indicating a better functional status.	30 days post subject discharge
Secondary	Functional Status - at inclusion and 30 days	The EQ-VAS will be used to assess functional status. Participants rate their health from 0 (worst imaginable health) to 100 (best imaginable health).	30 days post subject discharge