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
  Purpose

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 Intervention Phase
Bloodloss
Drug: Ringer-lactate "SAD"
Drug: HES 130/04
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Rigshospitalet, Denmark

Additional 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
Study First Received: September 10, 2011
Last Updated: December 12, 2013
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014