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

NCT01051206 | Completed Phase 4 DMC

• 1 other identifier: 4-2009-0057
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Occlusive Disease

Outcome Measures

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

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

Interventions

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 18, 2010
• Study Start: May 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: July 12, 2010

Record last verified: 2010-06

Locations

KR (1)