Prompt closure versus gradual weaning of external ventricular drain for hydrocephalus following aneurysmal subarachnoid haemorrhage: a statistical analysis plan for the DRAIN randomised clinical trial
Permanent link
https://hdl.handle.net/10037/35616Date
2024-07-15Type
Journal articleTidsskriftartikkel
Peer reviewed
Author
Capion, Tenna; Lilja-Cyron, Alexander; Juhler, Marianne; Moeller, Kirsten; Sorteberg, Angelika; Rønning, Pål Andre; Poulsen, Frantz Rom; Wismann, Joakim; Schack, Anders Emil; Ravlo, Celina; Isaksen, Jørgen Gjernes; Lindschou, Jane; Gluud, Christian; Mathiesen, Tiit; Olsen, Markus HarboeAbstract
Methods - DRAIN (Danish RAndomised Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage) is an international multicentre randomised clinical trial comparing prompt closure versus gradual weaning of the EVD after aSAH. The primary outcome is a composite of VP-shunt implantation, all-cause mortality, or EVD-related infection. Secondary outcomes are serious adverse events excluding mortality and health-related quality of life (EQ-5D-5L). Exploratory outcomes are modified Rankin Scale, Fatigue Severity Scale, Glasgow Outcome Scale Extended, and length of stay in the neurointensive care unit and hospital. Outcome assessment will be performed 6 months after ictus. Based on the sample size calculation (event proportion 80% in the gradual weaning group, relative risk reduction 20%, alpha 5%, power 80%), 122 participants are required in each intervention group. Outcome assessment for the primary outcome, statistical analyses, and conclusion drawing will be blinded. Two independent statistical analyses and reports will be tracked using a version control system, and both will be published. Based on the final statistical report, the blinded steering group will formulate two abstracts.
Conclusion - We present a pre-defined statistical analysis plan for the randomised DRAIN trial, which limits bias, p-hacking, and data-driven interpretations. This statistical analysis plan is accompanied by tables with simulated data, which increases transparency and reproducibility.