NCT05204849

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

Status unknown NA Last updated 10 February 2022

What this trial tests

NA trial testing IRRAflow in Intraventricular Hemorrhage in 58 participants. Status unknown.

Timeline

13 January 2022

Primary endpoint
1 February 2025

1 February 2025

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	13 January 2022
Primary completion	1 February 2025
Estimated completion	1 February 2025
Sites	1 location across Denmark

Drugs / interventions tested

• IRRAflow
• Standard ventriculostomy

Conditions studied

• Intraventricular Hemorrhage — all drugs for Intraventricular Hemorrhage →

Sponsor

University of Aarhus

Who can join

18 and older, any sex, with Intraventricular Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intraventricular Lavage vs External Ventricular Drainage for Intraventricular Hemorrhage: A Randomized Clinical Trial.
   Haldrup M, Rasmussen M, Mohamad N, Dyrskog S, et al · · 2023 · cited 11× · PMID 37815832 · DOI 10.1001/jamanetworkopen.2023.35247
2. 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.
   Haldrup M, Mohamad N, Rasmussen M, Thorup L, et al · · 2022 · cited 6× · PMID 36581996 · DOI 10.1186/s13063-022-07043-9
3. Reliability and performance of the IRRAflow® system for intracranial lavage and evacuation of hematomas-A technical note.
   Haldrup M, Nazari M, Gu C, Rasmussen M, et al · · 2024 · cited 4× · PMID 38626156 · DOI 10.1371/journal.pone.0297131
4. Descriptive registry study on outcome and complications of external ventricular drainage treatment of intraventricular haemorrhage in a Danish cohort: a study protocol.
   Gu C, Haldrup M, Rasmussen M, Dyrskog S, et al · · 2024 · PMID 38238178 · DOI 10.1136/bmjopen-2023-075997
5. Safety, harm, and efficacy of IRRAflow^®versus external ventricular drainage for intraventricular hemorrhage: A randomized clinical trial
   Haldrup M, Rasmussen M, Mohamad N, Dyrskog S, et al · · 2023 · DOI 10.1101/2023.07.08.23292286
6. Blood clot resolution using active fluid exchange in the treatment of intraventricular hemorrhage
   Haldrup M, Jakobsen AM, Rasmussen M, Dyrskog S, et al · · 2023 · DOI 10.1101/2023.07.04.23292127
7. 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
   Haldrup M, Mohamad N, Rasmussen M, Thorup L, et al · · 2022 · DOI 10.21203/rs.3.rs-1993202/v1
8. Safety and feasibility evaluation of external ventricular drainage with ACTIVE fluid exchange in intraventricular hemorrhage: A phase 2, multi-center, randomized controlled trial
   Haldrup M, Mohamad N, Rasmussen M, Thorup L, et al · · 2022 · DOI 10.21203/rs.3.rs-1676122/v1