The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspiri
- Conditions
- Bleeding after removal large colorectal polyps in patients taking aspirin in profilactic doses or placeboTherapeutic area: Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
- Registration Number
- EUCTR2012-001270-28-PL
- Lead Sponsor
- Medical Centre of Postgraduate Education, Poland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 760
Inclusion Criteria:
1. Age 40 years or older
2. Daily aspirin for primary or secondary prophylaxis
3. Candidate for endoscopic polypectomy of at least one colorectal polyp 10mm or larger
4. Signed written informed consent
5. Written opinion from a cardiologist that the patient can cease taking aspirin for a period of 21 days in the peri-polypectomy period
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 760
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Polyposis syndrome
2. Lifelong anticoagulant therapy with warfarin, acenocumarol, clopidogrel or ticlopidin
3. Haemorrhagic diathesis
4. Coagulation disorders INR > 1,5, APTT 2xnorm
5. Coagulation disorders in family
6. Heart failure (NYHA III-IV)
7. Lung disease limiting activities of daily living
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method