Hydroxyethylstarch induced coagulopathy and haemostatic potential of fibrinogen - in vivo placebo controlled clinical trial.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000026-44-DK

Enrollment

Registered

2007-03-28

Start date

2007-04-19

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. MedDRA version: 9.1 Level: PT Classification code 10060906 Term: Dilutional coagulopathy MedDRA version: 9.1 Level: LLT Classification code 10016595 Term: Fibrinogen

Interventions

Trade Name: Haemocomplettan Product Name: Haemocomplettan Pharmaceutical Form: Powder for solution for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • > 18 år • Indication for cystektomia • Written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: 20 patients planed for cystektomia due to urin bladder cancer;Secondary Objective: 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. ;Primary end point(s): Thromboelastographic parameteres: maksimum clot firmness MCF	—

Measure

Time frame

Main Objective: 20 patients planed for cystektomia due to urin bladder cancer;Secondary Objective: 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. ;Primary end point(s): Thromboelastographic parameteres: maksimum clot firmness MCF

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026