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Completed

NCT Number: NCT01938300

Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients undergoing a laparoscopic colorectal cancer surgery

Exclusion criteria

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

Treatment and study plan

Magnesium sulfate

Drug

normal saline

Drug

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Change of Alpha angle of INTEM

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

  5. Change of MCF of INTEM

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

  6. Change of CT of EXTEM

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

  7. Change of CFT of EXTEM

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

  8. Change of Alpha angle of EXTEM

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

  9. Change of MCF of EXTEM

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

Secondary outcomes

  1. Change of Hemoglobin

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

  2. Change of Platelet count

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

  3. 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

  4. Change of Activated partial thrombin time

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

  5. Change of Fibrinogen

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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 10, 2013
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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