Neoplasma malignum vesicae urinaria MedDRA version: 14.1 Level: LLT Classification code 10029100 Term: Neoplasm urinary bladder System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Macrodex
Product Name: Macrodex
Product Code: D.SP.NR 1180
Pharmaceutical Form: Infusion
INN or Proposed INN: Macrodex
Other descriptive name: DEXTRAN 70
Concentration unit: mg/ml milligra
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: No intracerebral hemorrhage No manifest kidney- hepatic- or heart disease Capable of his own affairs Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Volume of hemorrhage;Timepoint(s) of evaluation of this end point: 5 hours | — |
Countries
Denmark
Contacts
Public ContactK C Rasmussen
Rigshospitalet
Outcome results
None listed