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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02206412
Other study ID # 4-2013-0341
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2014
Est. completion date March 16, 2017

Study information

Verified date July 2014
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

High mobility group 1 (HMGB1) protein is both a nuclear factor and a secreted protein, and has recently been identified as a cytokine mediator of systemic inflammation. HMGB1 is released by inflammatory cells actively, or increased during cell death passively and mediates inflammatory response. It has been reported to have association with the prognosis after acute coronary syndrome, ischemia-reperfusion injury of myocardium, atherosclerosis and heart failure. This study aimed to investigate the relationship of serum levels of HMGB1 and post operative prognosis of patients who had undergone off-pump coronary artery bypass graft.


Recruitment information / eligibility

Status Completed
Enrollment 255
Est. completion date March 16, 2017
Est. primary completion date March 16, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. Age = 20

2. Patients undergoing off-pump coronary artery bypass graft

Exclusion Criteria:

1. Age < 20

2. Patients undergoing off-pump coronary artery bypass graft with other simultaneous surgery

3. Patients participating other study

Study Design


Related Conditions & MeSH terms

  • Coronary Artery Occlusive Disease

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum value of HMGB1 Measure the maximum value of HMGB1 in all patients and calculate median value. And device into upper median value group and under median value group and compare frequency of composite morbidity/mortality rate between two groups. composite morbidity/mortality is as follows:
Stroke
Renal failure
Prolonged ventilation more than 24 hours
Deep sternal wound infection
Reoperation for any reason
Mortality during the hospitalization for surgery, even if over 30 days
Change from induction of anesthesia to 2hrs after transfer to intensive care unit
See also
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Completed NCT01067638 - The Effect of Tranexamic Acid on Postoperative Blood Loss and Coagulation in Patients With Preoperative Anemia Undergoing Off-Pump Coronary Artery Bypass Graft; Double Blind Randomized Control Study Phase 4
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