The Effect of 6% Hydroxyethyl Starch 130/0.4 on Blood Loss and Coagulation in Patients Medicated With Antiplatelet Agents Prior to Off-Pump Coronary Bypass Graft Surgery

NCT ID: NCT01051206

Last Updated: 2010-07-12

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

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-02-28

Brief Summary

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HES 130/0.4 significantly solution will not affect on coagulation and blood loss in patients medicated with antiplatelet agents prior to off-pump coronary bypass surgery (OPCAB).

Detailed Description

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Conditions

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Coronary Artery Occlusive Disease

Study Design

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Primary Study Purpose

PREVENTION

Interventions

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6% hydroxyethyl Stach 130/0.4

After dividing patients medicated with HES 130/0.4(maximum 33ml/kg/day) during surgery and one day after from the surgery with patients medicated with crystalloid only, compare the effect on the volume of bleeding, blood transfusion, and blood coagulation when using IV fluid.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Eighty patients undergoing OPCAB, who were exposed to anti platelet agents until 5 days prior to surgery were randomly allocated to infuse HES 130/0.4 up to 30 ml/kg and followed crystalloid infusion or infuse crystalloid only during perioperative period,

Exclusion Criteria

Patient who has

* Valvular disease of heart
* MI within 3 months,patient under 40% of left ventricle preoperative output
* left main artery stenosis
* anemia (hemoglobin \< 12 g/dl), coagulopathy (Platelet \< 100/nl, activated partial thromboplastin time, aPTT) \> 80sec, serum creatinine \> 1.2 mg/dl, respiratory disease(asthma, COPD, PaO2 \< 70 mmHg, pulmonary hypertension or pulmonary edema, etc)
* not consented to this trial
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Assistant Professor of Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, South Korea

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2009-0057

Identifier Type: -

Identifier Source: org_study_id

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