The study population will consist of patients admitted for an elective implantation of a pacemaker or an arrhythmia device. The underlying medical conditions warranting the implantation of the device in this population are various. Generally accepted guidelines for the clinical indications will be followed. The clinical indications for warfarin use in the study population are also various and generally accepted indications for anticoagulant treatment.
Conditions
Interventions
Trade Name: Marevan 3 mg
Product Name: Marevan 3 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Dicumarol—Dicoumarol
CAS Number: 81-81-2
Other descriptive name: anticoagulant warfarin
Concentrati
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any patient scheduled for an elective implantation of pacemaker or arrhythmia device currently treated with warfarin, aspirin or neither. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Excessive intensity of anticoagulation as defined by International Normalized Ratio (INR) of more than 3.0 - Known bleeding disorder or hemorrhagic diathesis - Known contraindication for pacemaker implantation - Previously implanted mechanical heart valve prosthesis - Any contraindication for interrupting warfarin treatment - Significant anemia as defined by hemoglobin level of less than 100 g/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the effects on hemorrahagic and thromboembolic complications of pacemaker impalntation of either interrupting warfarin therapy two days prior to the procedure or continuing the therapy maintained within target INR range. ;Secondary Objective: 1. Is the use of aspirin associated with hemorrhagic complications? 2. Does the topical administration of the hemostatic product Arista® reduce bleeding complications? 3. What are the risk factors for hemorrhagic complications of pacemaker implantation?;Primary end point(s): 1. Clinically significant bleeding as determined by a drop blood hemoglobin level by at least 20 g/L or bleeding requiring transfusion of red blood cells or whole blood. 2. Severe local hematomas at pacemaker implantation site as defined by prolonged duration of hospital stay or necessitating surgical revision. 3. Number and size of moderate and mild local hematomas. 4. Any thromboambolic event. 5. Use of pharmaceutical or blood products to control bleeding (vitamin K, Arista®, fresh frozen plasma, concentrated clotting factors). | — |
Countries
Finland
Outcome results
None listed