Effect of Colloid Versus Crystalloid on Coagulation

Bloodloss Clinical Trial

Official title:

Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01444508
• Other study ID #: 2011-003270-80
• Status: Unknown status
• Phase: Phase 4
• First received: September 10, 2011
• Last updated: December 12, 2013
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Rigshospitalet, Denmark
• Contact: Niels H Secher, Professor
• Phone: +45 3545 2242
• Email: nielsh.secher[@]rh.regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

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

Eligibility

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.

Related Conditions & MeSH terms

• Bloodloss

Intervention

Drug:
• Ringer-lactate "SAD"
Lactated Ringer's is administrated intravenously in the dosis of max. 35 ml/kg during the operation after securing normovolaemia with Nexfin Monitor at induction of the anaesthesia: if bolus infusion of 200 ml increases stroke volume more than 10 % the patient is not assumed normovolaemic and bolus infusions are repeated until normovolaemic status is achieved.
• HES 130/04
Voluven is administered intravenously in the doses of max. 35 ml/kg during the operation. Normovolaemia is achieved in the same way as described in intervention by Ringer-lactate "SAD".

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
K. C. Rasmussen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of colloid versus crystalloid on laboratory coagulation.	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.	5-7 hours
Secondary	Effect of colloid versus crystalloid on the amount of bloodloss	The water balance inclusive the amount of bloodloss is registrated at the end of the operation and 2 hours later on.	5-7 hours