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Completed

NCT Number: NCT01512628

Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty

The investigators administered different kinds of colloids before transfusion of red blood cell to patient undergoing total hip replacement arthroplasty. The investigators will compare the differences of changes in rotational thromboelastometry (ROTEM) data among them.

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Key information

Conditions

Avascular Necrosis of Hip Total Hip Replacement Arthroplasty

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam, Gyounggi, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed as avascular necrosis of hip and undergoing total hip replacement arthroplasty

Exclusion criteria

  • hematologic disease
  • anticoagulant medication
  • preoperative hemoglobin < 10 g/dl
  • renal disease
  • pulmonary disease (pulmonary edema, effusion)
  • cardiovascular disease (coronary heart disease, congestive heart failure)

Treatment and study plan

Pentaspan, voluven, volulyte

Drug

Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.

Primary outcomes

  1. INTEM parameters change from preoperative values at post-operation

    Time frame: 30 minutes before operation and 30 minutes after operation

    clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)

  2. EXTEM parameters change from preoperative values at post-operation

    Time frame: 30 minutes before and 30 minutes after operation.

    clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)

  3. FIBTEM parameters change from preoperative values at post-operation

    Time frame: 30 min before and 30 min after operation

    maximum clot firmness (mm)

Secondary outcomes

  1. Infused total fluid volume

    Time frame: Participants will be followed for the duration of THRA operation in operating room, an expected average tiem of 3 hours

    crystalloid and colloid

  2. Hemoglobin

    Time frame: 30 minutes before operation and 30 minutes after operation

  3. postoperative blood loss

    Time frame: postoperative 1 day and 2 day

  4. Hematocrit

    Time frame: 30 minutes before operation and 30 minutes after operation

  5. Platelet

    Time frame: 30 minutes before operation and 30 minutes after operation

  6. Prothrombin Time-Internatiolnal Normalized Ratio

    Time frame: 30 minutes before operation and 30 minutes after operation

  7. Activated Partial Thrombin Time

    Time frame: 30 minutes before operation and 30 minutes after operation

  8. electrolytes

    Time frame: 30 minutes before operation and 30 minutes after operation

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Hemostatic Changes After Colloid Fluid Administration During Total Hip Replacement Arthroplasty

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 19, 2012
Registry last updated
Jan 28, 2014

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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