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Compares treatment options for Chronic Subdural Hematoma
Official title Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation
ClinicalTrials.gov ID: NCT06696079
What this study is testing
What is Early Resumption of Oral Anticoagulation Therapy?
Early Resumption of Oral Anticoagulation Therapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic subdural hematoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this randomized clinical trial is to assess the benefit of early resumption versus late resumption of oral anticoagulation medication in adults with atrial fibrillation undergoing surgery for chronic subdural hematoma. The main questions it aims to answer are: Does anticoagulation resumption 5 days after surgery as compared to 30 days after surgery result in fewer thromboembolic complications, without increasing the risk for bleeding?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years.
- Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation with drainage (CSDH is predominantly hypodense or isodense on...
- 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
You likely can't join if
- 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)
See the full eligibility 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 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Oulu, North Ostrobothnia, Finland
- Kuopio, Northern Savonia, Finland
- Tampere, Pirkanmaa, Finland
- Turku, Southwest Finland, Finland
- Helsinki, Uusimaa, Finland
- Stockholm, Region Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oulu, North Ostrobothnia, Finland; Kuopio, Northern Savonia, Finland; Tampere, Pirkanmaa, Finland; Turku, Southwest Finland, Finland; Helsinki, Uusimaa, Finland; Stockholm, Region Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.