Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

K. C. Rasmussen

Status and phase: Completed; Phase 4

Conditions: Disorders of Coagulation

Treatments: Drug: Lactated Ringer; Drug: Hydroxyethylstarch

Study type: Interventional

Funder types: Other

Identifiers

NCT02009033

H-2-2011-063

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 1 patient group

Ringer's lactate

Experimental group

Description:

Fluid therapy during operation

Treatment:

Drug: Lactated Ringer

Drug: Hydroxyethylstarch