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CompletedNCT01512628Updated Jan 28, 2014

Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty

An interventional study of Pentaspan, voluven, volulyte in Avascular Necrosis of Hip and Total Hip Replacement Arthroplasty, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-01-28.

Sponsored by Seoul National University Bundang Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Avascular Necrosis of Hip
  • Total Hip Replacement Arthroplasty
03

In context

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Active comparator
    PENTA group

    Pentaspan is administered as a colloid.

    Drug: Pentaspan, voluven, volulyte

  • Active comparator
    voluVEN group

    Voluven is administered as a colloid.

    Drug: Pentaspan, voluven, volulyte

  • Active comparator
    voluLYTE group

    Volulyte is administered as a colloid.

    Drug: Pentaspan, voluven, volulyte

Interventions

06

What researchers measure

Primary outcomes

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

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

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

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

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

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

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

    maximum clot firmness (mm)

    Time frame: 30 min before and 30 min after operation

Secondary outcomes

  1. Infused total fluid volume

    crystalloid and colloid

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

  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

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, Gyounggi 463-707, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01512628
Responsible party
Hyo-Seok Na (Assistant professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Jan 19, 2012
Start date
Jan 2012
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Jan 28, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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