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CompletedNCT02009033Updated Dec 11, 2013

Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

A Phase 4 interventional study of Lactated Ringer and Hydroxyethylstarch in Disorders of Coagulation, sponsored by K. C. Rasmussen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-11.

Sponsored by K. C. Rasmussen · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Disorders of Coagulation

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03

In context

Hemostatic Disorders

515 studies on the registry are indexed under Hemostatic Disorders; 72 are open to participants now.

This study's planned enrollment of 40 is below the median of 52 across 261 interventional studies indexed under Hemostatic Disorders.

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Lead sponsor

K. C. Rasmussen is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Ringer's lactate

    Fluid therapy during operation

    Drug: Lactated Ringer · Drug: Hydroxyethylstarch

Interventions

  • 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.

  • DrugHydroxyethylstarch
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02009033
Lead sponsor
K. C. Rasmussen
Responsible party
K. C. Rasmussen (MD, Copenhagen University Hospital, Rigshospitalet) — Sponsor-investigator
First posted
Dec 11, 2013
Start date
Sep 2011
Primary completion
Apr 2013
Completion
Dec 2013
Last update
Dec 11, 2013

Study contacts

Niels Henry Secher, Professor
study chair · Rigshospitalet , Dept. 2042, 2100 Copenhagen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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