NCT02009033

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2011

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

1.6 years

First QC Date

July 18, 2011

Last Update Submit

December 6, 2013

Conditions

Disorders of Coagulation

Outcome Measures

Primary Outcomes (1)

  • Estimate coagulation on basis of bloodsamples

    6 months

Secondary Outcomes (1)

  • Estimate coagulation by bloodloss and need for transfusion

    6 months

Study Arms (1)

Ringer's lactate

EXPERIMENTAL

Fluid therapy during operation

Drug: Lactated RingerDrug: Hydroxyethylstarch

Interventions

Lactated RingerDRUG

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.

Ringer's lactate
HydroxyethylstarchDRUG
Ringer's lactate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

Ringer's LactateHydroxyethyl Starch Derivatives

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsStarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Niels Henry Secher, Professor

    Rigshospitalet , Dept. 2042, 2100 Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 18, 2011

First Posted

December 11, 2013

Study Start

September 1, 2011

Primary Completion

April 1, 2013

Study Completion

December 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12