Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery. A Randomised Clinical Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02009033

Enrollment

Registered

2013-12-11

Start date

2011-09-30

Completion date

2013-12-31

Last updated

2013-12-11

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

Conditions

Disorders of Coagulation

Brief summary

The purpose of this study is to investigate the effect of thin fluid with starch versus thin fluid without starch on coagulation in elective surgery when the patient is normovolæmic during operation.

Detailed description

The primary goal is to register coagulation on basis of blood samples inclusive thromboelastography results. The secondary goal is to register blood loss and use of blood products during operation. The trial concerns 40 patients.

Interventions

DRUGLactated Ringer

When normovolæmic status of the patient is secured, 35 ml/kg of the allocated fluid is infused during the operation (estimated time for this type of operation is 180 minutes), however max. 3500 ml.Lactated Ringer is the interventional medication.

DRUGHydroxyethylstarch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient older than 18 years. * Indication for elective surgery with removal of the urine bladder. * Patient without anticoagulative, acethylsalisylsyre or NSAID medicine during the last 5 days,if using.

Exclusion criteria

* Cerebral haemorrhage * Renal insufficiency demanding dialysis * Manifest cardiac and hepatic insufficiency * Disturbance in coagulation * Hypernatriæmi * Hyperchloræmi * Pregnant or nursing * Allergic to hydroxyethylstarch * Participating in another trial-if interferring the present trial * Incapable of managing his own affairs.

Design outcomes

Primary

Measure	Time frame
Estimate coagulation on basis of bloodsamples	6 months

Secondary

Measure	Time frame
Estimate coagulation by bloodloss and need for transfusion	6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026