NCT05472766: ATTAACH

Anticoagulation Therapy Timing in Atrial Fibrillation After Acute and Chronic Subdural Hematoma

Terminated NA Last updated 4 June 2024

What this trial tests

NA trial testing Direct Acting Oral Anticoagulant starting at Day 30 in Subdural Hematoma in 1 participant. Terminated before completion.

Timeline

24 November 2022

Primary endpoint
22 March 2024

10 May 2024

Quick facts

Lead sponsor	Sunnybrook Health Sciences Centre
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1
Start date	24 November 2022
Primary completion	22 March 2024
Estimated completion	10 May 2024
Sites	1 location across Canada

Drugs / interventions tested

• Direct Acting Oral Anticoagulant starting at Day 30 — full drug profile →
• Direct Acting Oral Anticoagulant starting at Day 90 — full drug profile →

Conditions studied

• Subdural Hematoma — all drugs for Subdural Hematoma →
• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Sunnybrook Health Sciences Centre — full company profile →

Who can join

18 and older, any sex, with Subdural Hematoma or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Subdural hematoma (SDH) is a common disorder that typically results from head trauma and has increased in prevalence in recent decades. Acute subdural hematomas (aSDH) are found in up to one-third of patients with severe traumatic brain injury and are associated with an unfavorable outcome in the majority of cases. Chronic subdural hematomas (cSDH) commonly occur in the elderly population which has highest risk for developing cSDH with or without minor head injuries. The combination of the aging population, higher incidence of disease in progressively older patients, and high morbidity and mortality renders SDH a growing problem within Canada with significant health-systems burden. SDH commonly recurs even after successful surgical drainage. Atrial fibrillation (AF) is one of the most common medical comorbidities in patients with cSDH, especially in the elderly, with an expected doubling of its prevalence by the year 2030. Patients with AF are at recognized risk for stroke, so anticoagulation is indicated for almost all patients. Anticoagulation is held prior to SDH drainage to minimize the risk of intraoperative and early postoperative bleeding. After surgery, the risk of SDH recurrence must be balanced against the risk of thromboembolic events such as stroke when deciding the timing of resuming anticoagulation. Currently the decision on when to restart anticoagulation after SDH is made by clinicians on an individual patient basis without any high-quality evidence to guide this decision. The two most common approaches are: 1) early resumption of anticoagulation after 30 days of diagnosis or surgery; and 2) delayed resumption of anticoagulation after 90 days of diagnosis or surgery. However, which of these approaches leads to the best functional outcomes for patients is unclear. Our pilot RCT will test the feasibility of comparing these 2 approaches in a larger multicenter RCT.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Anticoagulation Therapy Timing in patients with Atrial Fibrillation after Acute and Chronic Subdural Haematoma (ATTAACH): a pilot randomised controlled trial.
   Mansouri A, Nassiri F, Scales D, Pirouzmand F. · · 2024 · cited 3× · PMID 39438108 · DOI 10.1136/bmjopen-2024-090224