Effect of Colloid Versus Crystalloid on Coagulation

Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Bloodloss
• Intervention / Treatment: Drug: Ringer-lactate "SAD"; Drug: HES 130/04

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

Contacts and Locations

• Study Contact: Name: Niels H Secher, Professor; Phone Number: +45 3545 2242; Email: nielsh.secher@rh.regionh.dk
• Study Contact Backup: Name: Kirsten C Rasmussen, MD; Phone Number: +45 35458735 +45 61335239; Email: dockcr@yahoo.com

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
    • Contact: Niels Henry Secher, Professor; Phone Number: +45 35452242; Email: niels.h.secher@rh.regionh.dk

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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: crystalloid	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.; Other Names: Ringer-laktat "SAD", B 05 BB 01, Amgros A/S.
Placebo Comparator: colloid	Drug: 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".; Other Names: Voluven, HES 130/04, B 05 AA 07, Fresenius Kabi A/S.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: K. C. Rasmussen

Publications and helpful links

General Publications

• Rasmussen KC, Johansson PI, Hojskov M, Kridina I, Kistorp T, Thind P, Nielsen HB, Ruhnau B, Pedersen T, Secher NH. Hydroxyethyl starch reduces coagulation competence and increases blood loss during major surgery: results from a randomized controlled trial. Ann Surg. 2014 Feb;259(2):249-54. doi: 10.1097/SLA.0000000000000267.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: September 10, 2011
• First Submitted That Met QC Criteria: September 29, 2011
• First Posted (Estimate): September 30, 2011

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: December 12, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 2011-003270-80