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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014