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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00006183
Other study ID # 131
Secondary ID U01HL063411
Status Completed
Phase Phase 3
First received August 21, 2000
Last updated July 28, 2016
Start date July 2000
Est. completion date July 2005

Study information

Verified date March 2008
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of diluted hematocrit (HCT) levels of 35% versus 25% during hypothermic cardiopulmonary bypass (CPB) in infants with d-transposition of the great arteries, a malformation of the heart vessels.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment


Intervention

Procedure:
Cardiopulmonary Bypass with Two Different Intra-Operative Hematocrits

Thoracic Surgery


Locations

Country Name City State
United States Children's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bassan H, Gauvreau K, Newburger JW, Tsuji M, Limperopoulos C, Soul JS, Walter G, Laussen PC, Jonas RA, du Plessis AJ. Identification of pressure passive cerebral perfusion and its mediators after infant cardiac surgery. Pediatr Res. 2005 Jan;57(1):35-41. Epub 2004 Nov 5. — View Citation

Jonas RA, Wypij D, Roth SJ, Bellinger DC, Visconti KJ, du Plessis AJ, Goodkin H, Laussen PC, Farrell DM, Bartlett J, McGrath E, Rappaport LJ, Bacha EA, Forbess JM, del Nido PJ, Mayer JE Jr, Newburger JW. The influence of hemodilution on outcome after hypothermic cardiopulmonary bypass: results of a randomized trial in infants. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1765-74. — View Citation

Kussman BD, Wypij D, DiNardo JA, Newburger J, Jonas RA, Bartlett J, McGrath E, Laussen PC. An evaluation of bilateral monitoring of cerebral oxygen saturation during pediatric cardiac surgery. Anesth Analg. 2005 Nov;101(5):1294-300. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Serum lactate levels (measured 1 hour after surgery)
Primary Developmental outcome (measured by Bayley Scales of Infant Development at age 1 year)
Secondary Duration of postoperative endotracheal intubation, ICU stay, and hospital stay
Secondary PaO2/FiO2 ratio
Secondary Levels of circulating pro-inflammatory cytokines
Secondary Percent change in total body water, as estimated by bioelectrical impedance (measured 1 hour after surgery)
Secondary Tissue release of S-100 protein as a measure of cerebral cellular injury
Secondary Cerebral hemodynamics and oxygenation, as determined by near infrared spectroscopy (NIRS)
Secondary Intrinsic cerebral vasoregulation, as measured by NIRS and transcranial Doppler
Secondary Neurologic factors, as determined by neurologic examination, the MacArthur inventory, and structural and volumetric findings of MRI (measured at age 1 year)
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