Trial record 6 of 7 for: "Exsanguination"

Previous Study | Return to List | Next Study

Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery

This study has been completed.

Sponsor:

Information provided by:

Larissa University Hospital

ClinicalTrials.gov Identifier:

NCT00600704

First received: January 14, 2008

Last updated: May 9, 2011

Last verified: March 2011

History of Changes

Results First Received: March 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Care Provider, Investigator); Primary Purpose: Supportive Care
Conditions:	Coronary Artery Disease Coronary Artery Bypass Erythrocyte Transfusion
Interventions:	Procedure: Fluid Restriction Policy Procedure: Free fluid infusion

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
RESTRICTED FLUIDS	Infusion of Hes 130/0.4 up to 500 ml
FREE FLUIDS	Free fluid infusion unless Hb< 6g/dl(allogenic blood use)

Participant Flow: Overall Study

	RESTRICTED FLUIDS	FREE FLUIDS
STARTED	100	92
COMPLETED	100	92
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
RESTRICTED FLUIDS	Infusion of Hes 130/0.4 up to 500 ml
FREE FLUIDS	Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
Total	Total of all reporting groups

Baseline Measures

	RESTRICTED FLUIDS	FREE FLUIDS	Total
Overall Participants Analyzed [Units: Participants]	100	92	192

Age [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	100	92	192
>=65 years	0	0	0

Age [Units: Years] Mean (Standard Deviation)	66 (7.9)	65.5 (8.3)	65.77 (8.1)

Gender [Units: Participants]
Female	17	16	33
Male	83	76	159

Region of Enrollment [Units: Participants]
Greece	100	92	192

Outcome Measures

1. Primary:

Mean Number of Packed Red Cells Units Transfused During Hospital Stay [ Time Frame: 20 months ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

More Information

Hide More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Dr Athina Kleitsaki
Organization: Larissa University Hospital Dept. of Anesthesiology
phone: 00306948481865
e-mail: theoath1@gmail.com

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	ATHINA KLEITSAKI, LARISSA UNIVERSITY HOSPITAL/DPT OF ANESTHESIOLOGY
ClinicalTrials.gov Identifier:	NCT00600704 History of Changes
Other Study ID Numbers:	LUH 1975 AK POL 1969 TT
Study First Received:	January 14, 2008
Results First Received:	March 4, 2011
Last Updated:	May 9, 2011

To Top