ArticleTrials2025
Restarting anticoagulation early versus late in patients with chronic subdural hematoma and atrial fibrillation (RELACS): a phase III international multicenter, randomized controlled, two-arm, assessor-blinded trial.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
24 authors.
Funding
Abstract
backgroundChronic subdural hematoma (CSDH) is a rapidly growing neurosurgical condition, driven primarily by an aging population and the increasing use of antithrombotic medications. Approximately 25% of CSDH patients are on anticoagulants due to atrial fibrillation (AF). The postoperative management of these patients presents a significant clinical challenge, as clinicians must balance the risks of thromboembolic and hemorrhagic complications. Currently, no evidence-based guidelines exist regarding the optimal timing for resuming anticoagulation therapy after surgery. This study aims to evaluate the net effect of early versus late postoperative resumption of oral anticoagulation in CSDH patients with AF. We hypothesize that early resumption will result in fewer thromboembolic complications and vascular deaths, without increasing the risk of hemorrhagic complications.
methodsThis is an investigator-initiated, international, multicenter, superiority, two-arm, assessor-blinded, phase 3 trial with 1:1 randomization, comparing early resumption (defined as 5 days) and late resumption (defined as 30 days) of oral anticoagulation medication after CSDH surgery in patients with AF. The primary outcome is a composite outcome that combines thromboembolic events, hemorrhagic events, and vascular death within 90 days of the surgery. Secondary outcomes include reoperations, functional outcome, and adverse events. The estimated sample size is 332 patients to achieve an 80% power and a two-sided alpha of 0.05 for the primary outcome, including potential dropouts. DISCUSSION: This is the first large-scale RCT addressing the critical evidence gap in anticoagulation timing after CSDH surgery. If early resumption proves superior, it could transform clinical practice by reducing thromboembolic complications without increasing hemorrhagic risk, potentially improving outcomes for the growing population of CSDH patients with AF worldwide.
trial registrationThe study is registered on June 4, 2025. The EU Clinical Trials Register (EUCTR) under identifier EUCT 2025-521179-29-00 ( https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2025-521179-29-00 ).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.