Back to resultsEffect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
Primary Purpose
Disorders of Coagulation
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lactated Ringer
Hydroxyethylstarch
Sponsored by
About this trial
This is an interventional treatment trial for Disorders of Coagulation
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ringer's lactate
Arm Description
Fluid therapy during operation
Outcomes
Primary Outcome Measures
Estimate coagulation on basis of bloodsamples
Secondary Outcome Measures
Estimate coagulation by bloodloss and need for transfusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02009033
Brief Title
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
Official Title
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery. A Randomised Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
K. C. Rasmussen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorders of Coagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ringer's lactate
Arm Type
Experimental
Arm Description
Fluid therapy during operation
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Hydroxyethylstarch
Primary Outcome Measure Information:
Title
Estimate coagulation on basis of bloodsamples
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Estimate coagulation by bloodloss and need for transfusion
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Henry Secher, Professor
Organizational Affiliation
Rigshospitalet , Dept. 2042, 2100 Copenhagen
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
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