Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

Disorders of Coagulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009033
• Other study ID #: H-2-2011-063
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2011
• Last updated: December 6, 2013
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Disorders of Coagulation
• Hemostatic Disorders

Intervention

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.
• Hydroxyethylstarch

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
K. C. Rasmussen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate coagulation on basis of bloodsamples		6 months	No
Secondary	Estimate coagulation by bloodloss and need for transfusion		6 months	No