ACTIVE Study - Use of ACTIVE Fluid Exchange to Treat Intraventricular Hemorrhage

NCT05204849 | Unknown DMC

• 1 other identifier: 47723569
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Randomised controlled trial evaluating active irrigation using IRRAflow device in patients with intraventricular hemorrhages (IVH). Patients will be randomized in a 1:1 fashion to IRRAflow active irrigation and aspiration compared to standard passive external ventricular drainage. The investigators hypothesize that active irrigation using the IRRAflow system will reduce the occlusion rates of the ventricular drain. Further, reduce the rate of catheter related infection and reduce time needed for clearance of blood from the intraventricular space compared with passive drainage alone. Further more, reduce treatment time, patient length of stay, and overall treatment cost when compared with passive drainage.

Conditions

Intraventricular Hemorrhage

Keywords

Intraventricular Hemorrhage; Ventriculostomy; Catheter occlusions; Catheter-Related Infections; Clearance of blood; Active irrigation and aspiration; IRRAflow

Outcome Measures

Primary Outcomes (1)

• Drain survival time

  Time to first observed occlusion of the catheter

  Time with ventricular catheter from placement to fist observed occlusion, an average of 11 days

Secondary Outcomes (6)

• Catheter related infections

  Time with ventricular catheter from placement to fist observed occlusion, an average of 11 days

• Rate of shunt dependency

  During the first 90 days after intervention

• Time to clearance of blood

  At day 0, 2, 4, 6, 8

• Length of stay at the ICU

  Expected between 1 and 30 days

• Functional outcomes - eGOS and mRS

  At inclusion, at discharge (an average of 30 days) and 90 days

Study Arms (2)

Active irrigation and aspiration

ACTIVE COMPARATOR

Patients randomized to IRRAflow will receive a ventricular catheter with active irrigation and aspiration.

Device: IRRAflow

Standard passive external ventricular drainage

ACTIVE COMPARATOR

Patients randomized to passive external ventricular drainage will receive a standard EVD.

Procedure: Standard ventriculostomy

Interventions

IRRAflow DEVICE

Ventriculostomy using IRRAflow with active irrigation and aspiration

Active irrigation and aspiration

Standard ventriculostomy PROCEDURE

Standard passive external ventricular drainage

Standard passive external ventricular drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years of age
• Intraventricular hemorrhage documented on head CT or MRI scan, no older than 24 hrs.
• Intraventricular hemorrhage Graeb Score ≥3 points
• Urgent need of cerebrospinal fluid drainage (\<24 hours)
• Indication for active treatment evaluated by the treating physicians
• Use of validated anti-conception in fertile female participants in concordance with guidelines provided by the Danish Health and Medicines Authority or a negative urine human chorion gonadotropin (HCG) test.

You may not qualify if:

• Patient has fixed and dilated pupils
• Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• IRRAS: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Related Publications (2)

• Haldrup M, Rasmussen M, Mohamad N, Dyrskog S, Thorup L, Mikic N, Wismann J, Gronhoj M, Poulsen FR, Nazari M, Rehman NU, Simonsen CZ, Korshoj AR. Intraventricular Lavage vs External Ventricular Drainage for Intraventricular Hemorrhage: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2335247. doi: 10.1001/jamanetworkopen.2023.35247.

  PMID: 37815832 DERIVED

• Haldrup M, Mohamad N, Rasmussen M, Thorup L, Dyrskog S, Simonsen CZ, Miscov R, Bjarkam CR, Gronhoj M, Poulsen FR, Korshoj AR. Study protocol for ACTIVE study: safety and feasibility evaluation of external ventricular drainage with ACTIVE fluid exchange in intraventricular hemorrhage-a phase 2, multi-center, randomized controlled trial. Trials. 2022 Dec 29;23(1):1062. doi: 10.1186/s13063-022-07043-9.

  PMID: 36581996 DERIVED

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Anders Korshøj, MD, PhD

  Dept. of Neurosurgery, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette Haldrup, MD

CONTACT

22715657; methalje@rm.dk

Anders Korshøj, MD, PhD

CONTACT

40956927; Andekors@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial, 1:1 fashion

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 24, 2022
• Study Start: January 13, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Protocol will be published primo 2022.

Locations

DK (1)