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Clinical Trials/NCT02009033
NCT02009033
Completed
Phase 4

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

K. C. Rasmussen0 sites40 target enrollmentSeptember 2011
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ConditionsDisorders of Coagulation
InterventionsHydroxyethylstarchLactated Ringer
DrugsLactated RingerHydroxyethylstarch

Overview

Phase
Phase 4
Intervention
Hydroxyethylstarch
Conditions
Disorders of Coagulation
Sponsor
K. C. Rasmussen
Enrollment
40
Primary Endpoint
Estimate coagulation on basis of bloodsamples
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
K. C. Rasmussen
Responsible Party
Sponsor Investigator
Principal Investigator

K. C. Rasmussen

MD

Rigshospitalet, Denmark

Eligibility Criteria

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.

Arms & Interventions

Ringer's lactate

Fluid therapy during operation

Intervention: Hydroxyethylstarch

Ringer's lactate

Fluid therapy during operation

Intervention: Lactated Ringer

Outcomes

Primary Outcomes

Estimate coagulation on basis of bloodsamples

Time Frame: 6 months

Secondary Outcomes

  • Estimate coagulation by bloodloss and need for transfusion(6 months)

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