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Completed

NCT Number: NCT02009033

Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

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.

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Key information

Conditions

Disorders of Coagulation Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactated Ringer

Drug

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.

Hydroxyethylstarch

Drug

Primary outcomes

  1. Estimate coagulation on basis of bloodsamples

    Time frame: 6 months

Secondary outcomes

  1. Estimate coagulation by bloodloss and need for transfusion

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

K. C. Rasmussen

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 11, 2013
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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