Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty

Study Overview
=================
Brief 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.

Official Title
-----------------
Hemostatic Changes After Colloid Fluid Administration During Total Hip Replacement Arthroplasty

Conditions
-----------------
Avascular Necrosis of Hip, Total Hip Replacement Arthroplasty

Intervention / Treatment
-----------------
* Drug: Pentaspan, voluven, volulyte


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PENTA group<br>Pentaspan is administered as a colloid. | Drug: Pentaspan, voluven, volulyte<br>* Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.<br>|
| Active Comparator: voluVEN group<br>Voluven is administered as a colloid. | Drug: Pentaspan, voluven, volulyte<br>* Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.<br>|
| Active Comparator: voluLYTE group<br>Volulyte is administered as a colloid. | Drug: Pentaspan, voluven, volulyte<br>* Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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