Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery. A Randomised Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Disorders of Coagulation
• Intervention / Treatment: Drug: Lactated Ringer; Drug: Hydroxyethylstarch

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimate coagulation on basis of bloodsamples	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Estimate coagulation by bloodloss and need for transfusion	6 months

Collaborators and Investigators

• Sponsor: K. C. Rasmussen
• Investigators: Study Chair: Niels Henry Secher, Professor, Rigshospitalet , Dept. 2042, 2100 Copenhagen

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 6, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: H-2-2011-063