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Clinical Trials/NCT01444508
NCT01444508
Unknown
Phase 4

Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

K. C. Rasmussen1 site in 1 country40 target enrollmentSeptember 2011

Overview

Phase
Phase 4
Intervention
Ringer-lactate "SAD"
Conditions
Bloodloss
Sponsor
K. C. Rasmussen
Enrollment
40
Locations
1
Primary Endpoint
Effect of colloid versus crystalloid on laboratory coagulation.
Last Updated
12 years ago

Overview

Brief Summary

In order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups.

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, specialist in surgery and research fellow

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Patient more than 18 years old
  • Indication for elective post-renal operation including cystectomy
  • Patient without anticoagulative, acetylsalicylic acid or NSAID treatment for the last 5 days.

Exclusion Criteria

  • Intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases
  • Pregnant or nursing
  • Disturbance in electrolytes
  • Patient under committee
  • Patient joining another trial interfering the actual trial.

Arms & Interventions

crystalloid

Intervention: Ringer-lactate "SAD"

colloid

Intervention: HES 130/04

Outcomes

Primary Outcomes

Effect of colloid versus crystalloid on laboratory coagulation.

Time Frame: 5-7 hours

Coagulation is analysed in bloodsamples before, during (10 minutes post cystectomia), at the end of the operation and 2 hours later on. The bloodsamples are analysed by thromboelastography (5000 series TEG analyzer, Haemoscope Corporation, Niles IL, USA) besides the classic coagulation parametres: platelet count, INR, Fibrinogen, APTT, D-dimer and Haemoglobin, Amylase and Creatinin.

Secondary Outcomes

  • Effect of colloid versus crystalloid on the amount of bloodloss(5-7 hours)

Study Sites (1)

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