NCT01521858

Brief Summary

Total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 29, 2013

Status Verified

August 1, 2013

Enrollment Period

1.1 years

First QC Date

January 9, 2012

Last Update Submit

August 28, 2013

Conditions

Avascular Necrosis of Hip

Outcome Measures

Primary Outcomes (8)

  • postoperative bleeding volume

    at first postoperative day

  • Hemoglobin

    preoperative 1 day and postoperative 1 day

  • hematocrit

    preoperative 1 day and postoperative 1 day

  • platelet

    preoperative 1 day and postoperative 1 day

  • prothrombin time_international normalized ratio

    preoperative 1 day and postoperative 1 day

  • activated partial prothrombin time

    preoperative 1 day and postoperative 1 day

  • fibrinogen concentration

    preoperative 1 day and postoperative 1 day

  • Rotational thromboelastometry

    preoperative 1 day and postoperative 1 day

Secondary Outcomes (3)

  • volume of infused fluid during operation

    Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)

  • intraoperative urine output

    Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)

  • transfusion units

    Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) and postoperative first day

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagosed with avascular necrosis of hip and undergoing total hip replacement arthroplasty

You may qualify if:

  • avascular necrosis of hip
  • total hip replacement arthroplasty

You may not qualify if:

  • revision operation
  • hematologic disease
  • anticoagulant medication
  • preoperative hemoglobin \< 10 g/dl
  • preoperative transfusion of red blood cells

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Gyounggi, 463-707, South Korea

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 31, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 29, 2013

Record last verified: 2013-08

Locations

KR(1)