Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Magnesium Sulfate
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- The patients undergoing a laparoscopic colorectal cancer surgery
Exclusion Criteria:
- Renal disease
- Hepatic disease
- Neuromuscular disease
- Coagulation disorder
- Cardiopulmonary disease
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Magnesium
Control
Arm Description
Magnesium sulfate infusion during a operation period. Infusion regimen: Bolus 50 mg/kg of magnesium sulfate in 100 ml normal saline over 15 minutes Infusion 15 mg/kg/h of magnesium sulfate throughout the operation
administration of normal saline as a same volume of magnesium sulphate as a same method.
Outcomes
Primary Outcome Measures
Change of maximum clot firmness (MCF) of FIBTEM
Change of Clotting time (CT) of INTEM
Change of Clot firmness time (CFT) of INTEM
Change of Alpha angle of INTEM
Change of MCF of INTEM
Change of CT of EXTEM
Change of CFT of EXTEM
Change of Alpha angle of EXTEM
Change of MCF of EXTEM
Secondary Outcome Measures
Change of Hemoglobin
Change of Platelet count
Change of International normalized ratio of prothrombin time
Change of Activated partial thrombin time
Change of Fibrinogen
Full Information
NCT ID
NCT01938300
First Posted
August 30, 2013
Last Updated
November 17, 2015
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01938300
Brief Title
Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium
Arm Type
Experimental
Arm Description
Magnesium sulfate infusion during a operation period.
Infusion regimen:
Bolus 50 mg/kg of magnesium sulfate in 100 ml normal saline over 15 minutes
Infusion 15 mg/kg/h of magnesium sulfate throughout the operation
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
administration of normal saline as a same volume of magnesium sulphate as a same method.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Type
Drug
Intervention Name(s)
Normal saline
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Change of Alpha angle of INTEM
Time Frame
1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Title
Change of MCF of INTEM
Time Frame
1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Title
Change of CT of EXTEM
Time Frame
1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Title
Change of CFT of EXTEM
Time Frame
1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Title
Change of Alpha angle of EXTEM
Time Frame
1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Title
Change of MCF of EXTEM
Time Frame
1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Secondary Outcome Measure Information:
Title
Change of Hemoglobin
Time Frame
1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Title
Change of Platelet count
Time Frame
1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Title
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
Title
Change of Activated partial thrombin time
Time Frame
1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Title
Change of Fibrinogen
Time Frame
1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients undergoing a laparoscopic colorectal cancer surgery
Exclusion Criteria:
Renal disease
Hepatic disease
Neuromuscular disease
Coagulation disorder
Cardiopulmonary disease
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery
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