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

March 27, 2019 updated by: Yonsei University
The purpose of study is to compare the effect of coagulation profile in patients receiving intraoperative balanced salt colloid undergoing spinal cord tumor surgery.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24hrs after anesthesia induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

January 31, 2015

Study Completion (Actual)

January 31, 2015

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 13, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

December 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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