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Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery

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ClinicalTrials.gov Identifier: NCT01938300
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital

Tracking Information
First Submitted Date  ICMJE August 30, 2013
First Posted Date  ICMJE September 10, 2013
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE June 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
  • Change of maximum clot firmness (MCF) of FIBTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  • Change of Clotting time (CT) of INTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  • Change of Clot firmness time (CFT) of INTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  • Change of Alpha angle of INTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  • Change of MCF of INTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  • Change of CT of EXTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  • Change of CFT of EXTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  • Change of Alpha angle of EXTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  • Change of MCF of EXTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01938300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
  • Change of Hemoglobin [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  • Change of Platelet count [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  • Change of International normalized ratio of prothrombin time [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  • Change of Activated partial thrombin time [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  • Change of Fibrinogen [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery
Official Title  ICMJE Not Provided
Brief Summary Magnesium sulphate is given to the patients during the colorectal cancer surgery under the hypothesis that it would attenuate the postoperative hypercoagulability. The investigators intend to characterize the changes of coagulation in colorectal cancer patients by using the point-of-care device after the infusion of magnesium sulphate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Magnesium Sulfate
  • Drug: Normal saline
Study Arms  ICMJE
  • Experimental: Magnesium

    Magnesium sulfate infusion during a operation period.

    Infusion regimen:

    1. Bolus 50 mg/kg of magnesium sulfate in 100 ml normal saline over 15 minutes
    2. Infusion 15 mg/kg/h of magnesium sulfate throughout the operation
    Intervention: Drug: Magnesium Sulfate
  • Placebo Comparator: Control
    administration of normal saline as a same volume of magnesium sulphate as a same method.
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2013)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patients undergoing a laparoscopic colorectal cancer surgery

Exclusion Criteria:

  • Renal disease
  • Hepatic disease
  • Neuromuscular disease
  • Coagulation disorder
  • Cardiopulmonary disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01938300
Other Study ID Numbers  ICMJE Mg-ROTEM-colorectal ca
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hyo-Seok Na, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Bundang Hospital
Verification Date November 2013

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