NCT01938300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2013

Enrollment Period

2.3 years

First QC Date

August 30, 2013

Last Update Submit

November 17, 2015

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (9)

  • Change of maximum clot firmness (MCF) of FIBTEM

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

  • Change of Clotting time (CT) of INTEM

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

  • Change of Clot firmness time (CFT) of INTEM

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

  • Change of Alpha angle of INTEM

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

  • Change of MCF of INTEM

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

  • Change of CT of EXTEM

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

  • Change of CFT of EXTEM

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

  • Change of Alpha angle of EXTEM

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

  • Change of MCF of EXTEM

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

Secondary Outcomes (5)

  • Change of Hemoglobin

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

  • Change of Platelet count

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

  • Change of International normalized ratio of prothrombin time

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

  • Change of Activated partial thrombin time

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

  • Change of Fibrinogen

    1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

Study Arms (2)

Magnesium

EXPERIMENTAL

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

Drug: Magnesium Sulfate

Control

PLACEBO COMPARATOR

administration of normal saline as a same volume of magnesium sulphate as a same method.

Drug: Normal saline

Interventions

Magnesium SulfateDRUG
Magnesium
Normal salineDRUG
Control

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients undergoing a laparoscopic colorectal cancer surgery

You may not qualify if:

  • Renal disease
  • Hepatic disease
  • Neuromuscular disease
  • Coagulation disorder
  • Cardiopulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Magnesium SulfateSaline Solution

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 10, 2013

Study Start

June 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 20, 2015

Record last verified: 2013-11

Locations

KR(1)