THRA_hematologic Variables

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01521858
First received: January 9, 2012
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition
Avascular Necrosis of Hip

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Relations Between Hematologic Variables and Postoperative Bleeding in Total Hip Replacement Arthroplasty

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • postoperative bleeding volume [ Time Frame: at first postoperative day ] [ Designated as safety issue: No ]
  • Hemoglobin [ Time Frame: preoperative 1 day and postoperative 1 day ] [ Designated as safety issue: No ]
  • hematocrit [ Time Frame: preoperative 1 day and postoperative 1 day ] [ Designated as safety issue: No ]
  • platelet [ Time Frame: preoperative 1 day and postoperative 1 day ] [ Designated as safety issue: No ]
  • prothrombin time_international normalized ratio [ Time Frame: preoperative 1 day and postoperative 1 day ] [ Designated as safety issue: No ]
  • activated partial prothrombin time [ Time Frame: preoperative 1 day and postoperative 1 day ] [ Designated as safety issue: No ]
  • fibrinogen concentration [ Time Frame: preoperative 1 day and postoperative 1 day ] [ Designated as safety issue: No ]
  • Rotational thromboelastometry [ Time Frame: preoperative 1 day and postoperative 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • volume of infused fluid during operation [ Time Frame: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) ] [ Designated as safety issue: No ]
    Infused total crystalloid and colloid volume during the operation will be recorded.

  • intraoperative urine output [ Time Frame: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) ] [ Designated as safety issue: No ]
  • transfusion units [ Time Frame: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) and postoperative first day ] [ Designated as safety issue: No ]
    Red blood cell


Enrollment: 73
Study Start Date: January 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • avascular necrosis of hip
  • total hip replacement arthroplasty

Exclusion Criteria:

  • revision operation
  • hematologic disease
  • anticoagulant medication
  • preoperative hemoglobin < 10 g/dl
  • preoperative transfusion of red blood cells
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521858

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyounggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Hyo-Seok Na, Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01521858     History of Changes
Other Study ID Numbers: B_1111_140_103
Study First Received: January 9, 2012
Last Updated: August 28, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Necrosis
Osteonecrosis
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 20, 2014