| Title: |
Intraventricular Lavage vs External Ventricular Drainage for Intraventricular Hemorrhage:A Randomized Clinical Trial |
| Authors: |
Haldrup, Mette; Rasmussen, Mads; Mohamad, Niwar; Dyrskog, Stig; Thorup, Line; Mikic, Nikola; Wismann, Joakim; Grønhøj, Mads; Poulsen, Frantz Rom; Nazari, Mojtaba; Rehman, Naveed Ur; Simonsen, Claus Ziegler; Korshøj, Anders Rosendal |
| Source: |
Haldrup, M, Rasmussen, M, Mohamad, N, Dyrskog, S, Thorup, L, Mikic, N, Wismann, J, Grønhøj, M, Poulsen, F R, Nazari, M, Rehman, N U, Simonsen, C Z & Korshøj, A R 2023, 'Intraventricular Lavage vs External Ventricular Drainage for Intraventricular Hemorrhage : A Randomized Clinical Trial', JAMA Network Open, vol. 6, no. 10, e2335247. https://doi.org/10.1001/jamanetworkopen.2023.35247 |
| Publication Year: |
2023 |
| Collection: |
University of Southern Denmark: Research Output / Syddansk Universitet |
| Subject Terms: |
Aged; Cerebral Hemorrhage/drug therapy; Drainage/adverse effects; Female; Humans; Intensive Care Units; Male; Therapeutic Irrigation |
| Description: |
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 ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
2574-3805 |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/37815832; info:eu-repo/semantics/altIdentifier/pissn/2574-3805; info:eu-repo/semantics/altIdentifier/eissn/2574-3805 |
| DOI: |
10.1001/jamanetworkopen.2023.35247 |
| Availability: |
https://portal.findresearcher.sdu.dk/da/publications/019f11ef-b52b-4564-bb92-eb7062e67018; https://doi.org/10.1001/jamanetworkopen.2023.35247; https://findresearcher.sdu.dk/ws/files/245107572/haldrup_2023_oi_231013_1696262212.88797.pdf |
| Rights: |
info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Accession Number: |
edsbas.C13EF71E |
| Database: |
BASE |