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Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

K

K. C. Rasmussen

Status and phase

Completed
Phase 4

Conditions

Disorders of Coagulation

Treatments

Drug: Lactated Ringer
Drug: Hydroxyethylstarch

Study type

Interventional

Funder types

Other

Identifiers

NCT02009033
H-2-2011-063

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 1 patient group

Ringer's lactate
Experimental group
Description:
Fluid therapy during operation
Treatment:
Drug: Lactated Ringer
Drug: Hydroxyethylstarch

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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