Effect of Colloid Versus Crystalloid on Coagulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01444508
Recruitment Status : Unknown
Verified December 2013 by K. C. Rasmussen, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : September 30, 2011
Last Update Posted : December 13, 2013
Information provided by (Responsible Party):
K. C. Rasmussen, Rigshospitalet, Denmark

September 10, 2011
September 30, 2011
December 13, 2013
September 2011
April 2013   (Final data collection date for primary outcome measure)
Effect of colloid versus crystalloid on laboratory coagulation. [ Time Frame: 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.

Same as current
Complete list of historical versions of study NCT01444508 on Archive Site
Effect of colloid versus crystalloid on the amount of bloodloss [ Time Frame: 5-7 hours ]
The water balance inclusive the amount of bloodloss is registrated at the end of the operation and 2 hours later on.
Same as current
Not Provided
Not Provided
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
  • 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 Name: Ringer-laktat "SAD", B 05 BB 01, Amgros A/S.
  • 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 Name: Voluven, HES 130/04, B 05 AA 07, Fresenius Kabi A/S.
  • Active Comparator: crystalloid
    Intervention: Drug: Ringer-lactate "SAD"
  • Placebo Comparator: colloid
    Intervention: Drug: HES 130/04
Rasmussen KC, Johansson PI, Højskov 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2013
April 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
K. C. Rasmussen, Rigshospitalet, Denmark
K. C. Rasmussen
Not Provided
Not Provided
Rigshospitalet, Denmark
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP