Effect of Colloid Versus Crystalloid on Coagulation

Phase 4

• Conditions: Bloodloss
• Interventions: Drug: Ringer-lactate "SAD"; Drug: HES 130/04

• Registration Number: NCT01444508
• Lead Sponsor: K. C. Rasmussen

Brief Summary

In order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-10
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Primary Completion: 2013-04
• Status Verified: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patient more than 18 years old
• Indication for elective post-renal operation including cystectomy
• Patient without anticoagulative, acetylsalicylic acid or NSAID treatment for the last 5 days.

Exclusion Criteria

• Intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases
• Pregnant or nursing
• Allergic
• Disturbance in electrolytes
• Patient under committee
• Patient joining another trial interfering the actual trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
crystalloid	Ringer-lactate "SAD"	-
colloid	HES 130/04	-

Primary Outcome Measures

Name	Time	Method
Effect of colloid versus crystalloid on laboratory coagulation.	5-7 hours	Coagulation is analysed in bloodsamples before, during (10 minutes post cystectomia), at the end of the operation and 2 hours later on.; The bloodsamples are analysed by thromboelastography (5000 series TEG analyzer, Haemoscope Corporation, Niles IL, USA) besides the classic coagulation parametres: platelet count, INR, Fibrinogen, APTT, D-dimer and Haemoglobin, Amylase and Creatinin.

Secondary Outcome Measures

Name	Time	Method
Effect of colloid versus crystalloid on the amount of bloodloss	5-7 hours	The water balance inclusive the amount of bloodloss is registrated at the end of the operation and 2 hours later on.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark