NCT02951741

Brief Summary

Revision 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
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

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

April 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

1.8 years

First QC Date

October 24, 2016

Last Update Submit

October 10, 2017

Conditions

Avascular Necrosis of HipDegenerative Hip Joint Disease

Outcome Measures

Primary Outcomes (1)

  • Change of FIBTEM

    FIBTEM: one of the measurements of the rotational thromboelastometry

    5 minutes before initiation of anesthesia and 5 minutes after finishing operation

Secondary Outcomes (16)

  • volume of infused fluid during operation

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

  • intraoperative urine output

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

  • transfusion units

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

  • postoperative bleeding volume

    postoperative 72 hours

  • Hemoglobin

    preoperative day 1

  • +11 more secondary outcomes

Study Arms (1)

RTHRA group

patients undergoing revision total hip replacement

Other: RTHRA group

Interventions

RTHRA groupOTHER

hematologic variables measurement in patients undergoing revision total hip replacement

RTHRA group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing revision total hip replacement

You may qualify if:

  • revision total hip replacement

You may not qualify if:

  • hematologic disease
  • anticoagulant medication
  • American Society of Anesthesiologists physical status 4 and 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Hyo-Seok Na, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 24, 2016

First Posted

November 1, 2016

Study Start

April 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)