Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty

Not Applicable

Completed

• Conditions: Avascular Necrosis of Hip; Total Hip Replacement Arthroplasty
• Interventions: Drug: Pentaspan, voluven, volulyte

• Registration Number: NCT01512628
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-14
• Study First Posted: 2012-01-19
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-26
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
voluVEN group	Pentaspan, voluven, volulyte	Voluven is administered as a colloid.
voluLYTE group	Pentaspan, voluven, volulyte	Volulyte is administered as a colloid.
PENTA group	Pentaspan, voluven, volulyte	Pentaspan is administered as a colloid.

Primary Outcome Measures

Name	Time	Method
EXTEM parameters change from preoperative values at post-operation	30 minutes before and 30 minutes after operation.	clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)
FIBTEM parameters change from preoperative values at post-operation	30 min before and 30 min after operation	maximum clot firmness (mm)
INTEM parameters change from preoperative values at post-operation	30 minutes before operation and 30 minutes after operation	clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)

Secondary Outcome Measures

Name	Time	Method
Infused total fluid volume	Participants will be followed for the duration of THRA operation in operating room, an expected average tiem of 3 hours	crystalloid and colloid
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyounggi, Korea, Republic of