Recombinant tissue plasminogen activator (alteplase) for restoration of function to occluded central venous catheters in pediatric patients
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Violet Shen1, Xin Li, Margie Murdock
1Children's Hospital of Orange County, 455 S. Main Street, Orange, CA 92868, USA. vshen@choc.org
Insights
Alteplase effectively restores function in pediatric occluded central venous catheters. This treatment is safe, with no major bleeding or intracranial hemorrhage reported in the study.
Area of Science:
- Pediatric critical care medicine
- Vascular access management
- Pharmacological interventions
Background:
- Central venous catheters (CVCs) are vital for pediatric patient care but are prone to occlusion.
- Catheter dysfunction necessitates timely intervention to maintain treatment continuity and avoid complications.
- Alteplase, a thrombolytic agent, is used to restore patency in occluded lines.
Purpose of the Study:
- To assess the safety and efficacy of alteplase in pediatric patients with occluded central venous catheters.
- To determine the success rate of alteplase in restoring catheter function.
- To evaluate the safety profile, specifically intracranial hemorrhage, associated with alteplase treatment.
Main Methods:
- A subset analysis of a phase III trial involving 122 pediatric patients (2-18 years) with dysfunctional nondialysis catheters.
- Alteplase (2 mg/2 mL) instilled into the catheter lumen, with redosing if needed.
- Efficacy assessed at 30 and 120 minutes; safety endpoint was intracranial hemorrhage within 5 days.
Main Results:
- Overall efficacy of alteplase was 87% after up to two doses.
- Catheter function was restored in 57% of patients within 30 minutes of a single dose.
- Treatment success was higher for shorter occlusion durations (91% for 0 days, 60% for >14 days) and independent of patient/catheter characteristics.
- No deaths, intracranial hemorrhages, major bleeding, or embolic events were reported.
Conclusions:
- Alteplase is a safe and effective option for restoring function in occluded pediatric central venous catheters.
- The regimen of up to two 2-mg doses demonstrated a high success rate.
- The study supports the use of alteplase in pediatric populations for managing catheter occlusion.
Purpose:
To evaluate the safety and efficacy of alteplase for restoring function to occluded central venous catheters in a pediatric population.
Patients And Methods:
A phase III, open-label, single-arm, multicenter trial was performed in 995 adult and pediatric patients with dysfunctional nondialysis catheters and ports. This report is a subset analysis of subjects between 2 and 18 years of age (N = 122) who were enrolled in the study. Alteplase (2 mg/2 mL) was instilled into the dysfunctional catheter lumen and assessed at 30 and 120 minutes. Subjects weighing > or =30 kg received 2 mL of alteplase; subjects <30 kg received 110% of the internal lumen volume (not exceeding 2 mL). Alteplase dosing was repeated once after 120 minutes if the catheter remained dysfunctional. The primary safety endpoint was the rate of intracranial hemorrhage (ICH) within 5 days of treatment.
Results:
The overall efficacy following up to two instilled doses of alteplase was 87%. In 70 patients (57%), restoration of catheter flow occurred by 30 minutes following a single dose of alteplase. Restoration of function was related to the duration of occlusion (P = 0.04). For catheters with occlusions of 0, 1 to 14, and >14 days duration, the efficacy was 91%, 78%, and 60%, respectively. Success was independent of the patient's age, sex, body weight, CVC type, or catheter age. There were no cases of death, ICH, major bleeding episodes, or embolic events attributable to treatment.
Conclusions:
An alteplase regimen of up to two 2-mg doses is safe and effective for restoration of function to occluded central venous catheters in a pediatric population.
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