Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty

NCT ID: NCT01512628

Last Updated: 2014-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Avascular Necrosis of Hip Total Hip Replacement Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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PENTA group

Pentaspan is administered as a colloid.

Group Type ACTIVE_COMPARATOR

Pentaspan, voluven, volulyte

Intervention Type DRUG

Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.

voluVEN group

Voluven is administered as a colloid.

Group Type ACTIVE_COMPARATOR

Pentaspan, voluven, volulyte

Intervention Type DRUG

Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.

voluLYTE group

Volulyte is administered as a colloid.

Group Type ACTIVE_COMPARATOR

Pentaspan, voluven, volulyte

Intervention Type DRUG

Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.

Interventions

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Pentaspan, voluven, volulyte

Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam, Gyounggi, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B1111-140-010

Identifier Type: -

Identifier Source: org_study_id

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