Effect of Colloid Versus Crystalloid on Coagulation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
K. C. Rasmussen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01444508
First received: September 10, 2011
Last updated: December 12, 2013
Last verified: December 2013

September 10, 2011
December 12, 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 ] [ Designated as safety issue: No ]

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 ClinicalTrials.gov Archive Site
Effect of colloid versus crystalloid on the amount of bloodloss [ Time Frame: 5-7 hours ] [ Designated as safety issue: No ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Bloodloss
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
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.
Both
18 Years and older
No
Contact: Niels H Secher, Professor +45 3545 2242 nielsh.secher@rh.regionh.dk
Contact: Kirsten C Rasmussen, MD +45 61335239 ext +45 35458735 dockcr@yahoo.com
Denmark
 
NCT01444508
2011-003270-80
No
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