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Impact of Balanced Slat Colloid HES 130/0.42 on Coagulation Profiles in Patients Undergoing Spinal Cord Tumor Surgery

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ClinicalTrials.gov Identifier: NCT01921595
Recruitment Status : Unknown
Verified July 2014 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : August 13, 2013
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
The purpose of study is to compare the effect of coagulation profile in patients receiving intraoperative balanced salt colloid undergoing spinal cord tumor surgery.

Condition or disease Intervention/treatment Phase
Coagulation Other: Valanced salt colloid Other: Valanced salt crystalloid group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : August 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Experimental: Valanced salt colloid group Other: Valanced salt colloid
Maximum dose : 30ml/kg, IV, The infusion of valanced salt colloid is started at bleeding and continued until reach at maximum dose

Active Comparator: Valanced salt crystalloid group Other: Valanced salt crystalloid group
Maximum dose : 30ml/kg, IV, The infusion of valanced salt crystalloid is started at bleeding and continued until reach at maximum dose




Primary Outcome Measures :
  1. Compare the effect of coagulation profile in patients receiving intraoperative balanced salt colloid undergoing spinal cord tumor surgery. [ Time Frame: up to 24hrs after anesthesia induction ]
    ROTEM, CBC, PT/aPTT,ABGA, Lactic acid, electrolyte



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients over the age of 20 scheduled for spinal tumor removal and fixation

Exclusion Criteria:

  • 1. Renal failure 2. Preexisting congestive heart failure(NYHA III ~ IV) 3. Anemia 4. Coagulopathy 5. Abnormal liver function 6. Anti coagulation/Anti platelet ,edication 7. Foreigner, illiterate 8. Disabled person,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921595


Contacts
Contact: Jong Wook Song, MD 2-2-2228-2420 SJW72331@yuhs.ac

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jong Wook Song, MD    82-2-2228-2420    SJW72331@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01921595     History of Changes
Other Study ID Numbers: 4-2013-0350
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by Yonsei University:
balanced salt colloid, coagulation profiles, spinal cord tumor

Additional relevant MeSH terms:
Spinal Cord Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases