Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

Phase 4CompletedNCT02009033

K. C. Rasmussen40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Disorders of Coagulation

Interventions

Lactated RingerDRUG

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.

HydroxyethylstarchDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Estimate coagulation on basis of bloodsamples

Time frame: 6 months

Secondary Outcomes

Estimate coagulation by bloodloss and need for transfusion

Time frame: 6 months

Data from ClinicalTrials.gov

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