Recombinant tissue plasminogen activator to restore catheter patency: efficacy and safety analysis from a multihospital NICU system.
In 2001, the US Food and Drug Administration approved recombinant tissue plasminogen activator (alteplase, Cathflo Activase) to reestablish patency of central catheters occluded, presumably, by a fibrin clot. We conducted a multicenter quality improvement study to determine the value of this procedure in our Neonatal Intensive Care Unit (NICUs), including analyses of efficacy, safety and costs.



We conducted a retrospective quality analysis of neonates in level III NICUs, who received alteplase for the purpose of reestablishing patency of occluded central catheters.



Alteplase was administered to 169 neonates, each given one to four doses, totaling 205 episodes of administration. The most common type of catheter where alteplase was used was percutaneously inserted central catheter (PICC) lines (78% of uses), 8% were umbilical venous catheters (UVCs), 6% arterial lines, 5% chest tubes and 3% other catheters. Postnatal age at first dose ranged from 0 to 132 days (median, 12); dosed patients were 22 to 41 weeks gestation at birth (median, 31). Fifty-eight percentage of administrations restored catheter function. Success was more likely at younger postnatal age (10±2 days old in successful vs 14±1 days in unsuccessful treatments; P=0.023). Seventy-two percentage of the re-canalized catheters remained functional until they were no longer needed (2 to 30 days later). Nine percentage of episodes were treated with a second dose 1 to 17 days later for re-occlusion and 50% of those were successful. Bleeding consequences were identified in only one case, where three separate lines were treated (chest tube, PICC and UVC) within a 6-h period. Costs to the health system of doses, minus savings to the system by not needing to replace lines, averaged a net of $34 per dose.



The apparent safety and favorable value analysis prompted us to develop a consistent approach to alteplase usage in the Intermountain Healthcare NICUs, using the data in this report to standardize the guidelines across our health system.
Women and Newborn's Clinical Program, Intermountain Healthcare, Salt Lake City, Utah, USA.|Department of Pharmacy Practice, Intermountain Medical Center, Murray, Utah, USA.
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DM
Scott
Women and Newborn's Clinical Program, Intermountain Healthcare, Salt Lake City, Utah, USA.|Division of Neonatology, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, Utah, USA.
C Y
CY
Ling
Division of Neonatology, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, Utah, USA.
B C
BC
MacQueen
Women and Newborn's Clinical Program, Intermountain Healthcare, Salt Lake City, Utah, USA.
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VL
Baer
Women and Newborn's Clinical Program, Intermountain Healthcare, Salt Lake City, Utah, USA.|Division of Neonatology, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, Utah, USA.|Division of Neonatology, Utah Valley Regional Medical Center, Provo, Utah, USA.
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E
Gerday
Women and Newborn's Clinical Program, Intermountain Healthcare, Salt Lake City, Utah, USA.|Division of Neonatology, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, Utah, USA.|Division of Hematology/Oncology, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, Utah, USA.
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RD
Christensen
D002405:Catheterization, Central Venous / Q000009:adverse effects*; D004868:Equipment Failure; D005260:Female; D005343:Fibrinolytic Agents / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal / Q000592:standards*; D008297:Male; D058996:Quality Improvement / Q000458:organization & administration; D011994:Recombinant Proteins / Q000191:economics / Q000627:therapeutic use; D012189:Retrospective Studies; D013927:Thrombosis / Q000517:prevention & control*; D010959:Tissue Plasminogen Activator / Q000191:economics / Q000627:therapeutic use*; D014589:Utah
D005343:Fibrinolytic Agents; D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator