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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01051206
First Posted: January 18, 2010
Last Update Posted: July 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  Purpose
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).

Condition Intervention Phase
Coronary Artery Occlusive Disease Drug: 6% hydroxyethyl Stach 130/0.4 Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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. ]

Estimated Enrollment: 106
Study Start Date: May 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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.
  Eligibility

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051206


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Jae Kwang Shim, Assistant Professor of Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, South Korea
ClinicalTrials.gov Identifier: NCT01051206     History of Changes
Other Study ID Numbers: 4-2009-0057
First Submitted: January 15, 2010
First Posted: January 18, 2010
Last Update Posted: July 12, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Platelet Aggregation Inhibitors
Plasma Substitutes
Blood Substitutes