The effect of exercise on function and concentrations of a single dose of unfractionated hepari
- Conditions
- nfractionated heparin is used for the prevention and treatment of deep vein thrombosis and complications hereofTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2023-000150-20-DK
- Lead Sponsor
- Bispebjerg-Frederiksberg Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 15
•Male between 18 and 50 years old
•Body weight 50 kg or more
•Body Mass Index 18.5-25 kg/m2
•Acceptance of not drinking alcohol for 24 hours before to 24 hours after dosing of study drug
•Acceptance of not performing physical activity for 24 hours before to 24 hours after dosing of study drug
•Signed informed consent form
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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
•History or sign of bleeding disorders
•History or sign of kidney disease
•History or sign of liver disease
•Average systolic blood pressure <100 mmHg or >140 mmHg and/or average diastolic blood pressure <60 mmHg or >90 mmHg (average of three measurements performed at screening).
•Daily pharmaceutical treatment
•Contraindication to increased levels of physical activity (10)
•Smoking or other regular use of any form of nicotine products during the study period and the previous 3 months.
•Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator).
•Previous treatment with heparins
•Low levels of anti-thrombin (P-antitrombin(enz.) <0,80 kIU/L)
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