Effects on coagulation and hemorrhage of fluids given during surgery in order to minimize loss of blood
- Conditions
- eoplasma malignum vesicae urinariaMedDRA version: 14.1Level: LLTClassification code 10029100Term: Neoplasm urinary bladderSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-005040-20-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Age more than 18 years, without anticoagulative medication for at least 5 days, planned removal of the urine bladder
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
No intracerebral hemorrhage
No manifest kidney- hepatic- or heart disease
Capable of his own affairs
Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Coagulation competence of the fluids;Secondary Objective: Volume of lost blood during surgery;Primary end point(s): Coagulationcompetence (blood speciments);Timepoint(s) of evaluation of this end point: 24 hours
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Volume of hemorrhage;Timepoint(s) of evaluation of this end point: 5 hours