Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation

Launched by RAHUL RAJ · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how quickly patients with atrial fibrillation (a heart condition) can safely resume taking blood-thinning medication after surgery for chronic subdural hematoma, which is a collection of blood on the brain that may need to be drained. The study aims to find out if starting the medication 5 days after surgery instead of waiting 30 days can prevent complications like blood clots, without causing more bleeding. Researchers will also look at whether the timing of medication affects the need for additional surgeries, overall recovery, and survival rates.

To participate in this trial, individuals must be at least 18 years old, have a diagnosed chronic subdural hematoma that requires surgery, and be taking blood thinners for their atrial fibrillation. Participants will be randomly assigned to either resume their medication 5 days or 30 days after their surgery. They will be monitored for three months to see how well they do. It's important to note that certain conditions, like recent bleeding complications or other serious health issues, may prevent someone from joining the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years.
• • Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation with drainage (CSDH is predominantly hypodense or isodense on imaging \[CT/MRI\]; clinical symptoms attributable to the CSDH; patients with bilaterally operated CSDHs will be treated with the same protocol on both sides and analyzed as a single study participant).
• • Patients that are on an oral anticoagulation medication due to permanent, persistent or paroxysmal spontaneous atrial fibrillation previously known
• • Randomization done within 4 days of the surgery
• Exclusion Criteria:
• • Intraoperative or immediate postoperative hemorrhagic complication
• • CSDH requiring surgical treatment other than burr-hole evacuation (e.g. craniotomy)
• • Prior CSDH surgery within 12 months
• • Cerebrospinal fluid shunt
• • CSDH is in an arachnoid cyst
• • If the operated hematoma is revealed to be a cerebrospinal fluid collection (hygroma)
• • Conditions other than atrial fibrillation that require anticoagulation, including therapeutical dose of low molecular-weight heparin or heparin (for example, pulmonary embolism, deep vein thrombosis, hypercoagulability syndromes)
• • Mechanical heart valve(s)
• • Moderate or severe mitral stenosis (other valvular diseases and biological valves are eligible)
• • Contraindication to anticoagulation medication (for example bleeding disorder, documented high risk of fall \[e.g. due to severe alcoholism\], severe thrombocytopenia, severe anemia)
• • Concomitant use of antiplatelet medication
• • Moderate to severe renal insufficiency (creatinine clearance \<30 ml/min or on dialysis)
• • Not a permanent resident in Finland (for Finnish patients) or not a permanent resident in Region Stockholm (for Swedish patients)