Back to resultsImpact of Balanced Slat Colloid HES 130/0.42 on Coagulation Profiles in Patients Undergoing Spinal Cord Tumor Surgery
Primary Purpose
Coagulation
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Valanced salt colloid
Valanced salt crystalloid group
Sponsored by
About this trial
This is an interventional other trial for Coagulation focused on measuring balanced salt colloid, coagulation profiles, spinal cord tumor
Eligibility 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,
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Valanced salt colloid group
Valanced salt crystalloid group
Arm Description
Outcomes
Primary Outcome Measures
Compare the effect of coagulation profile in patients receiving intraoperative balanced salt colloid undergoing spinal cord tumor surgery.
ROTEM, CBC, PT/aPTT,ABGA, Lactic acid, electrolyte
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01921595
Brief Title
Impact of Balanced Slat Colloid HES 130/0.42 on Coagulation Profiles in Patients Undergoing Spinal Cord Tumor Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
It ended early because it would not be possible to meet the target number.
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 31, 2015 (Actual)
Study Completion Date
January 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coagulation
Keywords
balanced salt colloid, coagulation profiles, spinal cord tumor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valanced salt colloid group
Arm Type
Experimental
Arm Title
Valanced salt crystalloid group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Valanced salt colloid
Intervention Description
Maximum dose : 30ml/kg, IV, The infusion of valanced salt colloid is started at bleeding and continued until reach at maximum dose
Intervention Type
Other
Intervention Name(s)
Valanced salt crystalloid group
Intervention Description
Maximum dose : 30ml/kg, IV, The infusion of valanced salt crystalloid is started at bleeding and continued until reach at maximum dose
Primary Outcome Measure Information:
Title
Compare the effect of coagulation profile in patients receiving intraoperative balanced salt colloid undergoing spinal cord tumor surgery.
Description
ROTEM, CBC, PT/aPTT,ABGA, Lactic acid, electrolyte
Time Frame
up to 24hrs after anesthesia induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Impact of Balanced Slat Colloid HES 130/0.42 on Coagulation Profiles in Patients Undergoing Spinal Cord Tumor Surgery
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