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Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

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ClinicalTrials.gov Identifier: NCT02009033
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
K. C. Rasmussen, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Disorders of Coagulation Drug: Lactated Ringer Drug: Hydroxyethylstarch Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery. A Randomised Clinical Study
Study Start Date : September 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ringer`s lactate
Fluid therapy during operation
Drug: Lactated Ringer
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.

Drug: Hydroxyethylstarch



Primary Outcome Measures :
  1. Estimate coagulation on basis of bloodsamples [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Estimate coagulation by bloodloss and need for transfusion [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009033


Sponsors and Collaborators
K. C. Rasmussen
Investigators
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Study Chair: Niels Henry Secher, Professor Rigshospitalet , Dept. 2042, 2100 Copenhagen

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Responsible Party: K. C. Rasmussen, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02009033     History of Changes
Other Study ID Numbers: H-2-2011-063
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
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Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders