Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938300
• Other study ID #: Mg-ROTEM-colorectal ca
• Status: Completed
• Phase: N/A
• First received: August 30, 2013
• Last updated: November 17, 2015
• Start date: June 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• The patients undergoing a laparoscopic colorectal cancer surgery

Exclusion Criteria:

• Renal disease

• Hepatic disease

• Neuromuscular disease

• Coagulation disorder

• Cardiopulmonary disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Magnesium Sulfate

• Normal saline

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of maximum clot firmness (MCF) of FIBTEM		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Primary	Change of Clotting time (CT) of INTEM		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Primary	Change of Clot firmness time (CFT) of INTEM		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Primary	Change of Alpha angle of INTEM		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Primary	Change of MCF of INTEM		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Primary	Change of CT of EXTEM		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Primary	Change of CFT of EXTEM		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Primary	Change of Alpha angle of EXTEM		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Primary	Change of MCF of EXTEM		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Secondary	Change of Hemoglobin		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Secondary	Change of Platelet count		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Secondary	Change of International normalized ratio of prothrombin time		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Secondary	Change of Activated partial thrombin time		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No
Secondary	Change of Fibrinogen		1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day	No