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Effect of Colloid Versus Crystalloid on Coagulation

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Bloodloss Drug: Ringer-lactate "SAD" Drug: HES 130/04 Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
Study Start Date : September 2011
Primary Completion Date : April 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Voluven, HES 130/04, B 05 AA 07, Fresenius Kabi A/S.


Outcome Measures

Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444508


Contacts
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

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Niels Henry Secher, Professor    +45 35452242    niels.h.secher@rh.regionh.dk   
Sponsors and Collaborators
K. C. Rasmussen
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: K. C. Rasmussen, MD, specialist in surgery and research fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01444508     History of Changes
Other Study ID Numbers: 2011-003270-80
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013