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Revision Total Hip Replacement Arthroplasty and Hematologic Variables

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ClinicalTrials.gov Identifier: NCT02951741
Recruitment Status : Completed
First Posted : November 1, 2016
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment
Avascular Necrosis of Hip Degenerative Hip Joint Disease Other: RTHRA group

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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relations Between Hematologic Variables and Postoperative Bleeding and Transfusion in Revision Total Hip Replacement Arthroplasty
Actual Study Start Date : April 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Group/Cohort Intervention/treatment
RTHRA group
patients undergoing revision total hip replacement
Other: RTHRA group
hematologic variables measurement in patients undergoing revision total hip replacement




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. volume of infused fluid during operation [ Time Frame: Period from starting to finishing the operation (During operation, an expected average of 3 hours) ]
    Infused total crystalloid and colloid volume during the operation will be recorded

  2. intraoperative urine output [ Time Frame: Period from starting to finishing the operation (During operation, an expected average of 3 hours) ]
  3. transfusion units [ Time Frame: Period from starting to finishing the operation (During operation, an expected average of 3 hours) and postoperative first day ]
    Red blood cell

  4. postoperative bleeding volume [ Time Frame: postoperative 72 hours ]
  5. Hemoglobin [ Time Frame: preoperative day 1 ]
  6. Hemoglobin [ Time Frame: postoperative day 4 ]
  7. Hematocrit [ Time Frame: preoperative day 1 ]
  8. Hematocrit [ Time Frame: postoperative day 4 ]
  9. Platelet count [ Time Frame: preoperative day 1 ]
  10. Platelet count [ Time Frame: postoperative day 4 ]
  11. prothrombin time_international normalized ratio [ Time Frame: preoperative day 1 ]
  12. prothrombin time_international normalized ratio [ Time Frame: postoperative day 1 ]
  13. activated partial prothrombin time [ Time Frame: preoperative day 1 ]
  14. activated partial prothrombin time [ Time Frame: postoperative day 1 ]
  15. fibrinogen concentration [ Time Frame: preoperative day 1 ]
  16. fibrinogen concentration [ Time Frame: postoperative day 1 ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing revision total hip replacement
Criteria

Inclusion Criteria:

  • revision total hip replacement

Exclusion Criteria:

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

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): NCT02951741


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Hyo-Seok Na, MD, PhD Seoul National University Bundang Hospital

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Responsible Party: Hyo-Seok Na, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02951741     History of Changes
Other Study ID Numbers: B-1502/288-302
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Joint Diseases
Osteoarthritis, Hip
Necrosis
Pathologic Processes
Musculoskeletal Diseases
Osteoarthritis
Arthritis
Rheumatic Diseases