Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01512628
First received: January 9, 2012
Last updated: January 26, 2014
Last verified: January 2014

January 9, 2012
January 26, 2014
January 2012
December 2013   (final data collection date for primary outcome measure)
  • INTEM parameters change from preoperative values at post-operation [ Time Frame: 30 minutes before operation and 30 minutes after operation ] [ Designated as safety issue: No ]
    clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)
  • EXTEM parameters change from preoperative values at post-operation [ Time Frame: 30 minutes before and 30 minutes after operation. ] [ Designated as safety issue: No ]
    clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)
  • FIBTEM parameters change from preoperative values at post-operation [ Time Frame: 30 min before and 30 min after operation ] [ Designated as safety issue: No ]
    maximum clot firmness (mm)
Same as current
Complete list of historical versions of study NCT01512628 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    crystalloid and colloid
  • Hemoglobin [ Time Frame: 30 minutes before operation and 30 minutes after operation ] [ Designated as safety issue: No ]
  • postoperative blood loss [ Time Frame: postoperative 1 day and 2 day ] [ Designated as safety issue: No ]
  • Hematocrit [ Time Frame: 30 minutes before operation and 30 minutes after operation ] [ Designated as safety issue: No ]
  • Platelet [ Time Frame: 30 minutes before operation and 30 minutes after operation ] [ Designated as safety issue: No ]
  • Prothrombin Time-Internatiolnal Normalized Ratio [ Time Frame: 30 minutes before operation and 30 minutes after operation ] [ Designated as safety issue: No ]
  • Activated Partial Thrombin Time [ Time Frame: 30 minutes before operation and 30 minutes after operation ] [ Designated as safety issue: No ]
  • electrolytes [ Time Frame: 30 minutes before operation and 30 minutes after operation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty
Hemostatic Changes After Colloid Fluid Administration During 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Avascular Necrosis of Hip
  • Total Hip Replacement Arthroplasty
Drug: Pentaspan, voluven, volulyte
Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.
  • Active Comparator: PENTA group
    Pentaspan is administered as a colloid.
    Intervention: Drug: Pentaspan, voluven, volulyte
  • Active Comparator: voluVEN group
    Voluven is administered as a colloid.
    Intervention: Drug: Pentaspan, voluven, volulyte
  • Active Comparator: voluLYTE group
    Volulyte is administered as a colloid.
    Intervention: Drug: Pentaspan, voluven, volulyte
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
December 2013
December 2013   (final data collection date for primary outcome measure)

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)
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01512628
B1111-140-010
No
Hyo-Seok Na, Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
Not Provided
Not Provided
Seoul National University Bundang Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP