Effect on coagulation and hemorrhage of fluids administered during surgery in order to minimize loss of blood.
Phase 1
Active, not recruiting
- Conditions
- Coagulation and loss of bloodMedDRA version: 16.1Level: LLTClassification code 10000122Term: Abnormal coagulation profileSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-005350-29-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Without anticoagulative mediation for at least 5 days and 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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
No intracerebral hemorrhage, no manifest kidney-hepatic or heart disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Coagulation competence;Secondary Objective: Loss of blood;Primary end point(s): Coagulation competence;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