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Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty

This study is currently recruiting participants.
Verified January 2012 by Seoul National University Bundang Hospital
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 14, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Avascular Necrosis of Hip
Total Hip Replacement Arthroplasty
 Drug: Pentaspan, voluven, volulyte

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Hemostatic Changes After Colloid Fluid Administration During Total Hip Replacement Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Hip Replacement
Drug Information available for: Hetastarch
U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 54
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PENTA group
Pentaspan is administered as a colloid.
 Drug: Pentaspan, voluven, volulyte
Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.
Active Comparator: voluVEN group
Voluven is administered as a colloid.
 Drug: Pentaspan, voluven, volulyte
Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.
Active Comparator: voluLYTE group
Volulyte is administered as a colloid.
 Drug: Pentaspan, voluven, volulyte
Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512628

Contacts
Contact: Hyo-Seok Na, Professor 82 31 787 7507 hsknana@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyounggi, Korea, Republic of, 463-707
Contact: Hyo-Seok Na, Professor     82-31-787-7507     hsknana@gmail.com    
Principal Investigator: Hyo-Seok Ns, Professor            
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Hyo-Seok Na, Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01512628     History of Changes
Other Study ID Numbers: B1111-140-010
Study First Received: January 9, 2012
Last Updated: January 14, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Necrosis
Osteonecrosis
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hetastarch
 Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013