E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The present study evaluates dilution coagulopathy induced by hydroxyethyl starch solutions in a clinical setting on patients undergoeing cystektomia due to bladder cancer. Furteher the haemostatic effect of fibrinogen concentrate is evaluated by randomised infusion following haemodilution. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060906 |
E.1.2 | Term | Dilutional coagulopathy |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016595 |
E.1.2 | Term | Fibrinogen |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
20 patients planed for cystektomia due to urin bladder cancer |
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E.2.2 | Secondary objectives of the trial |
Thromboelastographic parameteres like: Clotting time CT, clot formation time CFT, Maksimum velocity MaxVel, time until maksimum velocity t, MaxVel. Thrombocyte function. Amount and activity of coagulation factor VIII, XIII and von willebrand factor.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• > 18 år • Indication for cystektomia • Written informed consent
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E.4 | Principal exclusion criteria |
• Anticoagulant treatment and use of acetylsalicyclic acid and/or NSAID within 2 days. • Abnormale preoperative coagulationsparametres (Thr, PP, APTT, D-dimer, Fibrinogen, AT, TT) • Disseminated cancer and/or metastasis • Amnestic informations or records on schaemic heart disease, claudicatio, universel arteriosklerosis • Amnestic informations on familar and/or previous tromboembolic event • Renal failure defined as clinical relevant abnomal levels of creatinine • Liver failure defined as clinical relevant abnomal levels of ALAT • Hypersensibility to Voluven, Haemocomplettan eller ingredient substances • Fertile women not using contraception (contraceptive pill, diaphragm, condom)
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E.5 End points |
E.5.1 | Primary end point(s) |
Thromboelastographic parameteres: maksimum clot firmness MCF |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study ends with a total of twenty patients enrolled. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |