Effect of liquid with starch (Voluven) versus liquid without starch (Lactated Ringer) in elective abdominal operation.

Effect of colloid versus crystalloid on coagulation in elective urological surgery. A randomised clinical trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003270-80-DK

Enrollment

Registered

2011-08-18

Start date

2011-08-25

Completion date

Unknown

Last updated

2014-10-07

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

Conditions

Neoplasma malignum vesicae urinariae MedDRA version: 14.0 Level: LLT Classification code 10005004 Term: Bladder cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Ringers Lactat Pharmaceutical Form: Solution for infusion Trade Name: Voluven Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patienter over 18 år med indikation for elektiv postrenal aflastende operation med cystektomi. Hvis patienten er i antikoagulationsbehandling skal der være holdt pause med AK-behandling, ASA- og NSAID præparater i 5 dage. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Patienter med intrakraniel blødning, dialysekrævende nyresvigt, manifest hjerteinsufficiens, svær leversygdom og/eller svære koagulationsforstyrrelser (anamnestisk oplyst). Gravide og ammende (negativ graviditetstest ved inklusionen) Allergi overfor hydroxyethylstivelser Svær hypernatriæmi og hyperkloræmi. Patienter under værgetilsyn. Patienter, der indgår i et andet forsøg, såfremt det interfererer med nærværende forsøg

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if coagulation and loss of blood during the operation depends on the type of liquid usen to keep the patient normovolaemic estimated by optimizing cardiac output.;Secondary Objective: ;Primary end point(s): To estimate coagulation during operation when the patient is normovolaemic;Timepoint(s) of evaluation of this end point: After infusion, end of operation and two hours later	—

Measure

Time frame

Main Objective: To investigate if coagulation and loss of blood during the operation depends on the type of liquid usen to keep the patient normovolaemic estimated by optimizing cardiac output.;Secondary Objective: ;Primary end point(s): To estimate coagulation during operation when the patient is normovolaemic;Timepoint(s) of evaluation of this end point: After infusion, end of operation and two hours later

—

Secondary

Measure	Time frame
Secondary end point(s): estimate the amount of blood loss and need for transfusion;Timepoint(s) of evaluation of this end point: end of operation and two houra later	—

Countries

Denmark

Outcome results

None listed

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