Brief description of trial (Data source: BASEC)
Bei dieser Studie handelt es sich um eine
„randomisierte“, „placebokontrollierte“ „doppelblinde“ Studie.
„Randomisiert“ bedeutet, dass die Zuteilung zu einer Behandlungsgruppe rein zufällig erfolgt und dem Studienteam vorher nicht bekannt ist.
In den Gruppen werden am Studienende jeweils gleichviele Teilnehmer sein.
„Placebokontrolliert“ bedeutet, dass die Studienmedikation entweder Aspirin® cardio 100mg, oder ein Placebo ist. Ein Placebo ist eine identisch aussehende Tablette, die jedoch keinen Wirkstoff enthält.
„Doppelblind“ bedeutet, dass weder Teilnehmer noch Ärzte wissen, welche Studien-medikation eingenommen wird.
Je nach Gruppenzuteilung werden Sie in der perioperativen Zeit (= der Zeitraum vor, während und nach der Operation) für 12 Tage entweder 1 x täglich Aspirin® cardio 100 mg oder das Placebo bekommen.
Die Studiendauer für Sie als Teilnehmer beträgt sechs Monate.
Es ist geplant 142 Patienten einzuschliessen.
Der Studienzeitraum ist geplant von 2018 bis 2023.
Health conditions investigated(Data source: BASEC)
symptomatische chronische Subduralblutung
Health conditions
(Data source: WHO)
Chronic Subdural Hematoma
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Wir machen diese Studie, um herauszufinden, ob die Pausierung oder die Fortführung von Aspirin® cardio 100mg im Zeitraum vor, während und nach der Operation zu weniger bzw. mehr Rückfall-Blutungen oder thromboembolischen Komplikationen (z.B. Herzinfarkt) führt.
Interventions
(Data source: WHO)
Drug: Acetylsalicylic acid;Drug: Placebo Oral Tablet
Criteria for participation in trial
(Data source: BASEC)
- Informed Consent as documented by signature
(Appendix Informed Consent Form)
- Patients undergoing burr hole drainage for cSDH who are under low-dose ASA treatment for secondary prevention (Aspirin cardio® 100 mg once a day).
- Patients older than 18 years
- Patients receiving oral anticoagulation will be handled as described:
- Marcoumar: reversal of oral anticoagulant effect till reaching a Quick of at least 65% (INR 1.2) and discontinuation for 4 weeks postoperatively
- NOACS: if possible, discontinuation for at 24 hours before surgery. In case of emergency no discontinuation preoperatively and discontinuation for 4 weeks postoperatively
- Plavix: if possible, discontinuation 5 days before surgery. In case of emergency no discontinuation preoperatively and discontinuation postoperatively for 4 weeks
Exclusion criteria
(Data source: BASEC)
- Patients under the age of 18 years
- A recent (30 days before randomization) major cardiac event (i.e. unstable angina, myocardial infarction or coronary revascularization)
- A recent (30 days before randomization) active bleeding event
- Patient with known bleeding disorder (e.g. hemophilia)
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Patients undergoing burr hole trepanation for cSDH who are under low-dose aspirin
treatment ( Aspirin cardio 100mg once a day) for secondary prophylaxis
Exclusion Criteria:
- Patients under the age of 18years
- A recent (30 days before randomization) major cardiac event (i.e. unstable angina,
myocardial infarction, or coronary revascularization)
- A recent (30 days before randomization) active bleeding event.
- Patient with known bleeding disorder (e.g. hemophilia)
- No informed consent
-
Further information on trial
Date trial registered
Apr 10, 2017
Incorporation of the first participant
Feb 19, 2018
Recruitment status
Recruiting
Academic title
(Data source: WHO)
Impact of Perioperative Maintenance or Interruption of Low-dose Aspirin on Recurrence Rate and Thrombotic Events After Burr-hole Drainage of Chronic Subdural Hematoma: a Randomized, Placebo Controlled, Double Blinded Study
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Revision surgery due to a recurrent subdural hematoma
Secundary end point
(Data source: WHO)
Myocardial infarction;Stroke;Peripheral arterial occlusion;Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively;Intraoperative blood loss;Amount of blood/ fluid collected in the drain;Postoperative anemia;Operation time;Hospitalization time;Intraoperative blood transfusion rate;Postoperative blood transfusion rate;GCS Score;mRS;GOS;Clinical outcome
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
No
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Aarau, Basel, Chur, Luzern, St. Gallen
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
PD Dr. Jehduda Soleman
0041 78 623 44 88
jehuda.soleman@usb.ch
Contact for general information
(Data source: WHO)
Luigi Mariani, Prof, MD;Maria Kamenova, MD;Jehuda Soleman, MD
Department of Neurosurgery, University Hospital Basel
00413287814
maria.kamenova@usb.ch
Contact for scientific information
(Data source: WHO)
Luigi Mariani, Prof, MD;Maria Kamenova, MD;Jehuda Soleman, MD
Department of Neurosurgery, University Hospital Basel
00413287814
maria.kamenova@usb.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
05.04.2017
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-02003
Secondary ID (Data source: WHO)
SECA
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