Colorectal CancerNCT01938300
Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery
A study testing Magnesium Sulfate and Normal saline in people with Colorectal Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Magnesium Sulfate and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients undergoing a laparoscopic colorectal cancer surgery
Who cannot join
- Renal disease
- Hepatic disease
- Neuromuscular disease
- Coagulation disorder
- Cardiopulmonary disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
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.
- Conditions
- Colorectal Cancer
- Being tested
- Magnesium Sulfate, Normal saline
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Magnesium Sulfate |
| Control | Placebo comparator | administration of normal saline as a same volume of magnesium sulphate as a same method. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of maximum clot firmness (MCF) of FIBTEM
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of Clotting time (CT) of INTEM
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of Clot firmness time (CFT) of INTEM
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of Alpha angle of INTEM
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of MCF of INTEM
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of CT of EXTEM
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of CFT of EXTEM
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of Alpha angle of EXTEM
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of MCF of EXTEM
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Secondary outcomes (5)
Change of Hemoglobin
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of Platelet count
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of International normalized ratio of prothrombin time
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of Activated partial thrombin time
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Change of Fibrinogen
Measured: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startJun 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938300
- Sponsor's protocol ID
- Mg-ROTEM-colorectal ca
- Status last verified
- Nov 2013
- First submitted
- 30 Aug 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT01938300
- Acronym / sponsor ID
- Mg-ROTEM-colorectal ca
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Experimental | Drug: Magnesium SulfateMagnesium 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 |
| Control | Placebo comparator | Drug: Normal salineadministration of normal saline as a same volume of magnesium sulphate as a same method. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients undergoing a laparoscopic colorectal cancer surgery
Key exclusion criteria (5 listed)
- Renal disease
- Hepatic disease
- Neuromuscular disease
- Coagulation disorder
- Cardiopulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate | Drug | Magnesium |
| Normal saline | Drug | Control |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate and Normal saline in people with Colorectal Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.