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Completed

NCT Number: NCT01051206

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

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).

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Key information

Conditions

Coronary Artery Occlusive Disease

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6% hydroxyethyl Stach 130/0.4

Drug

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.

Primary outcomes

  1. 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 consumption

    Time frame: Preoperative thromboelastography (TEG) and other coagulation variables were measured and follow up data were collected at immediate postoperatively and 24 hours after surgery.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 18, 2010
Registry last updated
Jul 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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