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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

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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