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Randomized Controlled Trial
. 2023 Oct 2;6(10):e2335247.
doi: 10.1001/jamanetworkopen.2023.35247.

Intraventricular Lavage vs External Ventricular Drainage for Intraventricular Hemorrhage: A Randomized Clinical Trial

Mette Haldrup  1   2   3 , Mads Rasmussen  2   4 , Niwar Mohamad  1   2   4   5 , Stig Dyrskog  6 , Line Thorup  6 , Nikola Mikic  1   2 , Joakim Wismann  3   7 , Mads Grønhøj  3   7 , Frantz Rom Poulsen  3   7 , Mojtaba Nazari  8 , Naveed Ur Rehman  8 , Claus Ziegler Simonsen  2   9 , Anders Rosendal Korshøj  1   2
Affiliations
Randomized Controlled Trial

Intraventricular Lavage vs External Ventricular Drainage for Intraventricular Hemorrhage: A Randomized Clinical Trial

Mette Haldrup et al. JAMA Netw Open. .

Abstract

Importance: Intraventricular lavage has been proposed as a minimally invasive method to evacuate intraventricular hemorrhage. There is little evidence to support its use.

Objective: To evaluate the safety and potential efficacy of intraventricular lavage treatment of intraventricular hemorrhage.

Design, setting, and participants: This single-blinded, controlled, investigator-initiated 1:1 randomized clinical trial was conducted at Aarhus University Hospital and Odense University Hospital in Denmark from January 13, 2022, to November 24, 2022. Follow-up duration was 90 days. The trial was set to include 58 patients with intraventricular hemorrhage. Prespecified interim analysis was performed for the first 20 participants. Data were analyzed from February to April 2023.

Interventions: Participants were randomized to receive either intraventricular lavage or standard drainage.

Main outcomes and measures: The main outcome was risk of catheter occlusions. Additional safety outcomes were catheter-related infections and procedure time, length of stay at the intensive care unit, duration of treatment, and 30-day mortality. The main outcome of the prespecified interim analysis was risk of severe adverse events. Efficacy outcomes were hematoma clearance, functional outcome, overall survival, and shunt dependency.

Results: A total of 21 participants (median [IQR] age, 67 [59-82] years; 14 [66%] male) were enrolled, with 11 participants randomized to intraventricular lavage and 10 participants randomized to standard drainage; 20 participants (95%) had secondary intraventricular hemorrhage. The median (IQR) Graeb score was 9 (5-11), and the median (IQR) Glasgow Coma Scale score was 6.5 (4-8). The study was terminated early due to a significantly increased risk of severe adverse events associated with intraventricular lavage at interim analysis (risk difference for control vs intervention, 0.43; 95% CI, 0.06-0.81; P = .04; incidence rate ratio for control vs intervention, 6.0; 95% CI, 1.38-26.1; P = .01). The rate of catheter occlusion was higher for intraventricular lavage compared with drainage (6 of 16 patients [38%] vs 2 of 13 patients [7%]; hazard ratio, 4.4 [95% CI, 0.6-31.2]; P = .14), which met the prespecified α = .20 level. Median (IQR) procedure time for catheter placement was 53.5 (33-75) minutes for intraventricular lavage vs 12 (4-20) minutes for control (P < .001).

Conclusions and relevance: This randomized clinical trial of intraventricular lavage vs standard drainage found that intraventricular lavage was encumbered with a significantly increased number of severe adverse events. Caution is recommended when using the device to ensure patient safety.

Trial registration: ClinicalTrials.gov Identifier: NCT05204849.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Rasmussen reported receiving grants the Health Research Foundation Fund of Central Denmark Region outside the submitted work. Dr Simonsen reported receiving grants from Novo Nordisk Foundation and Health Research Foundation of Central Denmark Region outside the submitted work. Dr Korshøj reported receiving personal fees from IRRAS during the conduct of the study; grants from IRRAS (paid to Aarhus University Hospital), the Danish Cancer Society, the Lundbeck Foundation, and the Independent Research Fund Denmark outside the submitted work; and having a patent for a neuromonitoring technology pending with relation to the IRRAflow technology. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flowchart of Participant Enrollment, Allocation, Follow-Up, and Analysis
Figure 2.
Figure 2.. Kaplan-Meier Curves of Overall Survival in the 2 Groups
See this image and copyright information in PMC

Comment in

References

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