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Completed

NCT Number: NCT02951741

Revision Total Hip Replacement Arthroplasty and Hematologic Variables

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.

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Key information

Conditions

Avascular Necrosis of Hip Arthritis Degenerative Hip Joint Disease Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • revision total hip replacement

Exclusion criteria

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

Treatment and study plan

RTHRA group

Other

hematologic variables measurement in patients undergoing revision total hip replacement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2016
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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