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|---|---|---|---|
| POL 1969 TT |
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The investigators' hypothesis is that restriction of circulating fluids in comparison to a liberal fluid administration policy would lead to a reduction of allogenic red blood cells exposure in patients undergoing cardiopulmonary bypass (CPB) for primary coronary artery bypass graft supported by reinfusion of washed shed blood from thoracic cavities.
192 patients operated under equal conditions were assigned prospectively and randomly either for a restrictive protocol for intravenous fluid administration (group A, 100 patients) or not (group B, 92 patients). Transfusion guidelines were common for the two groups. The volumes of intravenous fluids, priming, "extra" volume on pump and cardioplegic solution and the volume of urine were recorded. Net erythrocyte volume loss was calculated. The number of the transfused PRC was analyzed as a continuous variable. "Transfusion" was analyzed as a categorical characteristic. Analysis employed Student's two-tailed t-test, t-paired test and chitest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RESTRICTED FLUIDS | Active Comparator | Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary Bypass |
|
| FREE FLUIDS | Active Comparator | Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid Restriction Policy | Procedure | Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary bypass |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Packed Red Cells Units Transfused During Hospital Stay | 20 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ATHINA KLEITSAKI, Dr | Larissa University Hospital | Principal Investigator |
| GEORGE VRETZAKIS, M.D. PhD | Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece | Study Director |
| KONSTANTINOS STAMOULIS, M.D. | Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece | Study Chair |
| CHRISTOS DRAGOUMANIS, M.D. PhD | Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece | Study Chair |
| VASILIOS TASOUDIS, M.D. | Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece | Study Chair |
| KATERINA KYRIAKAKI, M.D. | Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece | Study Chair |
| DEMETRIOS MIKROULIS, M.D. PhD | Department of Cardiothoracic Surgery, University Hospital of Larissa, Greece | Study Chair |
| ATHANASIOS GIANNOUKAS, MD MSc PhD | Department of Vascular Surgery, University Hospital of Larissa, Greece |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Larissa University Hospital | Larissa | Thesalia | 41110 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17462454 | Background | Society of Thoracic Surgeons Blood Conservation Guideline Task Force; Ferraris VA, Ferraris SP, Saha SP, Hessel EA 2nd, Haan CK, Royston BD, Bridges CR, Higgins RS, Despotis G, Brown JR; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion; Spiess BD, Shore-Lesserson L, Stafford-Smith M, Mazer CD, Bennett-Guerrero E, Hill SE, Body S. Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists clinical practice guideline. Ann Thorac Surg. 2007 May;83(5 Suppl):S27-86. doi: 10.1016/j.athoracsur.2007.02.099. | |
| 16153909 |
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Exclusion criteria were emergency or re-do operations, operations starting after 18.00, administration of tissue plasminogen activator (TPA) or other thrombolytic medications, pre-existing hematologic disease or coagulation abnormality, advanced cirrhosis, renal failure, preoperative blood product transfusion, combined cardiac and carotid surgery.
This prospective study was conducted in our University Hospital over a 20-month period, after approval from the Institution Ethics committee, and written informed consent was obtained from all patients before entering the study. All the participants were patients of the Cardio-Thoracic Clinic of our Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | RESTRICTED FLUIDS | Infusion of Hes 130/0.4 up to 500 ml |
| FG001 | FREE FLUIDS | Free fluid infusion unless Hb< 6g/dl(allogenic blood use) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RESTRICTED FLUIDS | Infusion of Hes 130/0.4 up to 500 ml |
| BG001 | FREE FLUIDS | Free fluid infusion unless Hb< 6g/dl(allogenic blood use) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Number of Packed Red Cells Units Transfused During Hospital Stay | Patients between ages 18-85 undergoing elective cardiac surgery under cardiopulmonary bypass | Posted | Mean | 95% Confidence Interval | packed red cells units | 20 months | PRC Units | Participants |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RESTRICTED FLUIDS | Infusion of Hes 130/0.4 up to 500 ml |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| myocardial infraction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| reoperation for bleeding | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Athina Kleitsaki | Larissa University Hospital Dept. of Anesthesiology | 00306948481865 | theoath1@gmail.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D058734 | Exsanguination |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Free fluid infusion | Procedure | Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass |
|
| NIKOLAOS TSILIMINGAS, M.D. PhD | Department of Cardiothoracic Surgery, University Hospital of Larissa, Greece | Study Chair |
| Background |
| Dial S, Delabays E, Albert M, Gonzalez A, Camarda J, Law A, Menzies D. Hemodilution and surgical hemostasis contribute significantly to transfusion requirements in patients undergoing coronary artery bypass. J Thorac Cardiovasc Surg. 2005 Sep;130(3):654-61. doi: 10.1016/j.jtcvs.2005.02.025. |
| 9477051 | Background | Stover EP, Siegel LC, Parks R, Levin J, Body SC, Maddi R, D'Ambra MN, Mangano DT, Spiess BD. Variability in transfusion practice for coronary artery bypass surgery persists despite national consensus guidelines: a 24-institution study. Institutions of the Multicenter Study of Perioperative Ischemia Research Group. Anesthesiology. 1998 Feb;88(2):327-33. doi: 10.1097/00000542-199802000-00009. |
| 16181875 | Background | Karkouti K, Djaiani G, Borger MA, Beattie WS, Fedorko L, Wijeysundera D, Ivanov J, Karski J. Low hematocrit during cardiopulmonary bypass is associated with increased risk of perioperative stroke in cardiac surgery. Ann Thorac Surg. 2005 Oct;80(4):1381-7. doi: 10.1016/j.athoracsur.2005.03.137. |
| 12830066 | Background | Habib RH, Zacharias A, Schwann TA, Riordan CJ, Durham SJ, Shah A. Adverse effects of low hematocrit during cardiopulmonary bypass in the adult: should current practice be changed? J Thorac Cardiovasc Surg. 2003 Jun;125(6):1438-50. doi: 10.1016/s0022-5223(02)73291-1. |
| 11269449 | Background | DeFoe GR, Ross CS, Olmstead EM, Surgenor SD, Fillinger MP, Groom RC, Forest RJ, Pieroni JW, Warren CS, Bogosian ME, Krumholz CF, Clark C, Clough RA, Weldner PW, Lahey SJ, Leavitt BJ, Marrin CA, Charlesworth DC, Marshall P, O'Connor GT. Lowest hematocrit on bypass and adverse outcomes associated with coronary artery bypass grafting. Northern New England Cardiovascular Disease Study Group. Ann Thorac Surg. 2001 Mar;71(3):769-76. doi: 10.1016/s0003-4975(00)02393-6. |
| 20187484 | Derived | Vretzakis G, Kleitsaki A, Stamoulis K, Dragoumanis C, Tasoudis V, Kyriakaki K, Mikroulis D, Giannoukas A, Tsilimingas N. The impact of fluid restriction policy in reducing the use of red blood cells in cardiac surgery. Acta Anaesthesiol Belg. 2009;60(4):221-8. |
| 20181257 | Derived | Vretzakis G, Kleitsaki A, Stamoulis K, Bareka M, Georgopoulou S, Karanikolas M, Giannoukas A. Intra-operative intravenous fluid restriction reduces perioperative red blood cell transfusion in elective cardiac surgery, especially in transfusion-prone patients: a prospective, randomized controlled trial. J Cardiothorac Surg. 2010 Feb 24;5:7. doi: 10.1186/1749-8090-5-7. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| PRC Units |
|
|
|
| 20 |
| 100 |
| 2 |
| 100 |
| EG001 | FREE FLUIDS | Free fluid infusion unless Hb< 6g/dl(allogenic blood use) | 18 | 92 | 2 | 92 |
| persistent significant arrythmia | Cardiac disorders | Non-systematic Assessment |
|
| low output syndrome | Congenital, familial and genetic disorders | Systematic Assessment |
|
| persistent neurological dysfunction | Nervous system disorders | Systematic Assessment |
|
| lower extremity ischemia | Vascular disorders | Non-systematic Assessment |
|
| renal failure | Renal and urinary disorders | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |