Back to resultsThe 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
Primary Purpose
Coronary Artery Occlusive Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
6% hydroxyethyl Stach 130/0.4
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Occlusive Disease
Eligibility 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
Sites / Locations
- Severance Hospital
Outcomes
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01051206
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Occlusive Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
6% hydroxyethyl Stach 130/0.4
Intervention Description
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 Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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
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