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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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01051206
Enrollment
106
Registered
2010-01-18
Start date
2009-05-31
Completion date
2010-02-28
Last updated
2010-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Occlusive Disease

Brief summary

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).

Interventions

DRUG6% 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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Primary purpose
PREVENTION

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
TEG, hemoglobin, platelet count, prothrombin time (PT), partial prothrombin time (aPTT), blood loss, amount of transfusion, urine output, comparing the record data of IV fluid consumptionPreoperative thromboelastography (TEG) and other coagulation variables were measured and follow up data were collected at immediate postoperatively and 24 hours after surgery.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026