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THRA_hematologic Variables

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01521858
First Posted: January 31, 2012
Last Update Posted: August 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital
  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

Further study details as provided by Hyo-Seok Na, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • postoperative bleeding volume [ Time Frame: at first postoperative day ]
  • Hemoglobin [ Time Frame: preoperative 1 day and postoperative 1 day ]
  • hematocrit [ Time Frame: preoperative 1 day and postoperative 1 day ]
  • platelet [ Time Frame: preoperative 1 day and postoperative 1 day ]
  • prothrombin time_international normalized ratio [ Time Frame: preoperative 1 day and postoperative 1 day ]
  • activated partial prothrombin time [ Time Frame: preoperative 1 day and postoperative 1 day ]
  • fibrinogen concentration [ Time Frame: preoperative 1 day and postoperative 1 day ]
  • Rotational thromboelastometry [ Time Frame: preoperative 1 day and postoperative 1 day ]

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) ]
    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) ]
  • transfusion units [ Time Frame: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) and postoperative first day ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 9, 2012
First Posted: January 31, 2012
Last Update Posted: August 29, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Necrosis
Pathologic Processes