NCT01921595

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2015

Completed
Last Updated

March 29, 2019

Status Verified

December 1, 2015

Enrollment Period

1.5 years

First QC Date

August 8, 2013

Last Update Submit

March 27, 2019

Conditions

Coagulation

Keywords

balanced salt colloid, coagulation profiles, spinal cord tumor

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 24hrs after anesthesia induction

Study Arms (2)

Valanced salt colloid group

EXPERIMENTAL
Other: Valanced salt colloid

Valanced salt crystalloid group

ACTIVE COMPARATOR
Other: Valanced salt crystalloid group

Interventions

Valanced salt colloidOTHER

Maximum dose : 30ml/kg, IV, The infusion of valanced salt colloid is started at bleeding and continued until reach at maximum dose

Valanced salt colloid group
Valanced salt crystalloid groupOTHER

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

Valanced salt crystalloid group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

ThrombosisSpinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 13, 2013

Study Start

August 1, 2013

Primary Completion

January 31, 2015

Study Completion

January 31, 2015

Last Updated

March 29, 2019

Record last verified: 2015-12

Locations

KR(1)