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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01051206
• Collaborator: (none)
• Enrollment: 106
• Location: 1
• Duration (Months): 9.1
• Patients Per Site Per Month: 11.7

Study Details

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).

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 106 participants
• 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
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01051206
• Other Study ID Numbers: 4-2009-0057
• First Posted: Jan 18, 2010
• Last Update Posted: Jul 12, 2010
• Last Verified: Jun 1, 2010

• Additional relevant MeSH terms: Hemorrhage

Study Results

No Results Posted as of Jul 12, 2010