---
title: AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
nct_id: NCT05649904
overall_status: RECRUITING
phase: NA
sponsor: Ohio State University
study_type: INTERVENTIONAL
primary_condition: Intraventricular Hemorrhage
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05649904.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05649904"
ct_last_update_post_date: 2025-04-01
last_seen_at: "2026-05-12T07:28:44.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis

**Official Title:** Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection

**NCT ID:** [NCT05649904](https://clinicaltrials.gov/study/NCT05649904)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 240
- **Lead Sponsor:** Ohio State University
- **Collaborators:** IRRAS
- **Conditions:** Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, Ventriculitis
- **Start Date:** 2023-02-07
- **Completion Date:** 2026-01
- **CT.gov Last Update:** 2025-04-01

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **IRRAflow with Active Fluid Exchange System (IRRAflow)** (EXPERIMENTAL) — Subjects may be randomized to receive the IRRAflow with Active Fluid Exchange System (intervention) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure.
- **External Ventricular Drainage (EVD)** (ACTIVE_COMPARATOR) — Subjects may be randomized to receive an External Ventricular Drain (control) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure.

## Interventions

- **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.

## Primary Outcomes

- **Rate of revision procedures for the IRRAflow and EVD/Drainage catheters** _(time frame: Immediately post-procedure)_

## Secondary Outcomes

- **Time to clearance of blood or bacterial mass as measured by head CT scan** _(time frame: Immediately post-procedure)_
- **Rate of catheter-related infection** _(time frame: Immediately post-procedure)_
- **Length of ICU stay** _(time frame: Baseline)_
- **Rate of shunt dependency** _(time frame: Immediately post-procedure)_
- **Indwell time of EVD/Drainage and IRRAflow Catheter** _(time frame: Immediately post-procedure)_
- **Functional Status - at inclusion and 30 days** _(time frame: 30 days post subject discharge)_
- **Mortality rates - intraprocedural and at 30 days** _(time frame: 30 days post subject discharge)_
- **Functional Status - at inclusion and 30 days** _(time frame: 30 days post subject discharge)_
- **Functional Status - at inclusion and 30 days** _(time frame: 30 days post subject discharge)_
- **Functional Status - at inclusion and 30 days** _(time frame: 30 days post subject discharge)_
- **Functional Status - at inclusion and 30 days** _(time frame: 30 days post subject discharge)_

## Locations (1)

- The Ohio State University Wexner Medical Center, Columbus, Ohio, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the ohio state university wexner medical center|columbus|ohio|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05649904.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05649904*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*