Impact of Fluid Restriction Policy Added to Intra-Operative Cell Salvage in Reducing the Use of Red Cells in Cardiac Surgery - Full Text View

Sponsored by:	Larissa University Hospital
Information provided by:	Larissa University Hospital
ClinicalTrials.gov Identifier:	NCT00600704

Purpose

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.

Condition	Intervention
Primary Coronary Artery Bypass Cardiac Surgery	Procedure: Fluid Restriction Policy Procedure: Free fluid infusion

MedlinePlus related topics: Coronary Artery Bypass Surgery Heart Surgery Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Caregiver, Investigator), Active Control, Parallel Assignment
Official Title:	Impact of Fluid Restriction Policy Added to Intra-Operative Cell Salvage in Reducing the Use of Red Cells in Cardiac Surgery

Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:

Evidence of reduction of use of allogenic blood by fluid restriction policy [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total blood loss [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment:	130
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
GROUP A: Active Comparator Infusion of Hes 130/0.4 up to 500 ml	Procedure: Fluid Restriction Policy Infusion of Hes 130/0.4 up to 500 ml
GROUP B: Active Comparator Free fluid infusion unless Hb< 6g/dl(allogenic blood use)	Procedure: Free fluid infusion Free fluid infusion unless Hb< 6g/dl(allogenic blood use)

Detailed Description:

130 patients operated under equal conditions were assigned prospectively and randomly either for a restrictive protocol for intravenous fluid administration (group A, 65 pts) or not (group B, 65 pts). 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ejection fraction (EF) of left ventricle (LV) > 35%
Preoperative serum Creatinine < 150 μmol/l
Preoperative Hb > 10/dl
Peripheral anastomosis scheduled =< 3

Exclusion Criteria:

redo bypass-emergency operations
prior coronal stenting
active congestive heart failure
documented MI within the previous 6 weeks
NYHA class > 3
Carotid stenosis > 50%
CVA
INR > 1.5
chronic obstructive pulmonary disease (COPD)
Steroid therapy-chronic inflammatory process
Use of aprotinin or tranexamic acid

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600704

Locations

Greece, THESALIA
Larissa University Hospital
LARISSA, THESALIA, Greece, 41110

Sponsors and Collaborators

Larissa University Hospital

Investigators

Principal Investigator:	ATHINA KLEITSAKI, Dr	Larissa University Hospital
Study Director:	GEORGE VRETZAKIS, M.D. PhD	Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece
Study Chair:	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
Study Chair:	NIKOLAOS TSILIMINGAS, M.D. PhD	Department of Cardiothoracic Surgery, University Hospital of Larissa, Greece

More Information

Publications:

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. Review.

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.

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.

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.

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.

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.

Responsible Party:	LARISSA UNIVERSITY HOSPITAL/DPT OF ANESTHESIOLOGY ( ATHINA KLEITSAKI )
Study ID Numbers:	LUH 1975 AK, POL 1969 TT
Study First Received:	January 14, 2008
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00600704 History of Changes
Health Authority:	Greece: Ethics Committee; Greece: Ministry of Health and Welfare; Greece: National Organization of Medicines

Keywords provided by Larissa University Hospital:

Allogenic Blood Use
Total Blood Loss
Reinfusion of Washed Shed Blood

Study placed in the following topic categories:

Hemorrhage

ClinicalTrials.gov processed this record on May 06, 2009