Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty

January 26, 2014 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyounggi
      • Seongnam, Gyounggi, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 minutes before operation and 30 minutes after operation
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)
30 minutes before and 30 minutes after operation.
FIBTEM parameters change from preoperative values at post-operation
Time Frame: 30 min before and 30 min after operation
maximum clot firmness (mm)
30 min before and 30 min after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants will be followed for the duration of THRA operation in operating room, an expected average tiem of 3 hours
Hemoglobin
Time Frame: 30 minutes before operation and 30 minutes after operation
30 minutes before operation and 30 minutes after operation
postoperative blood loss
Time Frame: postoperative 1 day and 2 day
postoperative 1 day and 2 day
Hematocrit
Time Frame: 30 minutes before operation and 30 minutes after operation
30 minutes before operation and 30 minutes after operation
Platelet
Time Frame: 30 minutes before operation and 30 minutes after operation
30 minutes before operation and 30 minutes after operation
Prothrombin Time-Internatiolnal Normalized Ratio
Time Frame: 30 minutes before operation and 30 minutes after operation
30 minutes before operation and 30 minutes after operation
Activated Partial Thrombin Time
Time Frame: 30 minutes before operation and 30 minutes after operation
30 minutes before operation and 30 minutes after operation
electrolytes
Time Frame: 30 minutes before operation and 30 minutes after operation
30 minutes before operation and 30 minutes after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 14, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 26, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1111-140-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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