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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2017041519470N56 |
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Date of registration:
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2017-04-21 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Comparison of effect of Valuven versus ringer solution in cardiopulmonary bypass prime on the postoperative bleeding and renal function in coronary artery bypass graft surgery
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Scientific title:
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The Comparison of effect of Valuven versus ringer solution in cardiopulmonary bypass prime on the postoperative bleeding and renal function in coronary artery bypass graft surgery |
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Date of first enrolment:
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2017-04-16 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/17429 |
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Study type:
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interventional |
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Study design:
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Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.
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Phase:
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2-3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Elahe allahyari
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Address:
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Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz
Iran (Islamic Republic of) |
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Telephone:
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+98 71 3647 4270 |
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Email:
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allahyarye@sums.ac.ir |
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Affiliation:
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Shiraz University of Medical Sciences |
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Name:
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Elahe Alahyari
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Address:
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Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz
Iran (Islamic Republic of) |
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Telephone:
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00 |
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Email:
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allahyary.elahe@gmail.com |
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Affiliation:
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Shiraz Universiy of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: patients undergoing coronary artery bypass graft (CABG) for the first time.
Exclusion criteria: undergoing cardiac surgery for the second time; emergency coronary artery bypass; coagulation disorders prior to surgery; the preoperative clopidogrel (Plavix); congestive heart failure before surgery; renal failure before surgery (creatinine greater than (1 / 3) with a previous history of heart surgery; heart failure; coagulation disorders including abnormal PT and PTT, INR, PLAT; kidney disease included high chromium 1.3 and taking Plavix (clopidogrel).
Exclusion criteria:
Age minimum:
40 years
Age maximum:
75 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Bypass Surgery.
Atherosclerotic heart disease
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Atherosclerotic heart disease
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Intervention(s)
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Intervention 1: Patients in group A received 1500 cc Ringer as a prime solution during preparation of (CPB). Intervention 2: Patients in group B received Valuven1500 ml, 130/04 (hydroxyethyl starch) during preparation of CPB. Monitoring of vital signs is recorded.
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Treatment - Drugs
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Patients in group A received 1500 cc Ringer as a prime solution during preparation of (CPB).
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Patients in group B received Valuven1500 ml, 130/04 (hydroxyethyl starch) during preparation of CPB. Monitoring of vital signs is recorded.
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Primary Outcome(s)
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Bleeding. Timepoint: during and after surgery. Method of measurement: Observasion.
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Secondary Outcome(s)
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Lab data (CR - Na-K -HB- hematocrit- PT- PTT-INR ). Timepoint: before surgery and 24 hours after surgery in the ICU. Method of measurement: blood sample.
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Source(s) of Monetary Support
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Vice Chancellor for Research, Shiraz University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Shiraz University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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