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Clinical Trials/NCT02951741
NCT02951741CompletedNot Applicable

Relations Between Hematologic Variables and Postoperative Bleeding and Transfusion in Revision Total Hip Replacement Arthroplasty

Seoul National University Bundang Hospital1 site in 1 country62 target enrollmentStarted: April 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
1
Primary Endpoint
Change of FIBTEM

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • revision total hip replacement

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change of FIBTEM

Time Frame: 5 minutes before initiation of anesthesia and 5 minutes after finishing operation

FIBTEM: one of the measurements of the rotational thromboelastometry

Secondary Outcomes

  • 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)
  • activated partial prothrombin time(postoperative day 1)
  • postoperative bleeding volume(postoperative 72 hours)
  • fibrinogen concentration(postoperative day 1)
  • Hemoglobin(postoperative day 4)
  • Hematocrit(postoperative day 4)
  • Platelet count(postoperative day 4)
  • prothrombin time_international normalized ratio(postoperative day 1)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hyo-Seok Na

Associate Professor

Seoul National University Bundang Hospital

Study Sites (1)

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