---
title: "High‑Dose, Tailored tPA Protocol in Pediatric Cardiac ICU: Safety, Effectiveness, and D‑dimer Patt"
id: "pubmed-42687681"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42687681"
content_type: "clinical_feed_article"
specialty: "Critical Care"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42687681/"
doi: "10.1002/1545-5017.70638"
published_at: "2026-09-03T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# High‑Dose, Tailored tPA Protocol in Pediatric Cardiac ICU: Safety, Effectiveness, and D‑dimer Patt
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42687681
- **Specialty:** [Critical Care](https://medichelpline.com/clinical-feed/critical-care.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42687681/)
- **DOI:** [10.1002/1545-5017.70638](https://doi.org/10.1002%2F1545-5017.70638)
- **Published At:** 2026-09-03T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This retrospective cohort study (July 2014–March 2024) evaluated a tailored, prolonged systemic **tissue plasminogen activator (tPA)** protocol for infants and children in a tertiary pediatric cardiac ICU. - Twenty-two patients received systemic tPA; median age 287 days (IQR 64.8–940), with 32% younger than 90 days. - Indications included stuck **mechanical valve** (n = 10), central venous thrombosis with chylothorax (n = 7), large venous thrombosis (n = 3), coronary thrombosis (n = 1), and arterial ischemic stroke (n = 1). - Median initial tPA dose was 0.1 mg/kg/h (IQR 0.06–0.1), with escalation to 0.5 mg/kg/h in selected cases; mean duration 3.9 ± 2.8 days. - Valve mobility was restored in 80% of mechanical valve cases; complete thrombus resolution was achieved for all venous, coronary, and stroke indications reported. - Minor bleeding events occurred in 23% of patients; one patient (5%) experienced a subdural hemorrhage. There were no in‑hospital deaths; all patients survived to discharge. - The study analyzed **D‑dimer** trajectories and found statistically significant differences between vessel thrombosis and mechanical valve obstruction (p < 0.01), indicating distinct fibrinolytic profiles. - Authors conclude that a tailored, prolonged systemic tPA regimen appears effective with acceptable adverse effects under strict monitoring and that **D‑dimer** dynamics may help guide therapy. They call for multicenter studies to validate standardized pediatric protocols. - The report underscores gaps in pediatric-specific thrombolysis protocols and persistent safety concerns, while providing single‑center experience supporting individualized high‑dose approaches.
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Online ahead of print. # Safety and Effectiveness of a High-Dose, Tailored Tissue Plasminogen Activator Therapy Protocol: A Joint Pediatric Hematology and Cardiac ICU Quality Improvement Initiative Analysis [Eran Shostak](https://pubmed.ncbi.nlm.nih.gov/?term=Shostak+E&cauthor_id=42687681)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#full-view-affiliation-1 "Pediatric Cardiac Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#full-view-affiliation-2 "Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel."), [Oded Gilad](https://pubmed.ncbi.nlm.nih.gov/?term=Gilad+O&cauthor_id=42687681)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#full-view-affiliation-2 "Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.")[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#full-view-affiliation-3 "Rina Zaizov Department of Pediatric Hematology-Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel."), [Yael Feinstein](https://pubmed.ncbi.nlm.nih.gov/?term=Feinstein+Y&cauthor_id=42687681)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#full-view-affiliation-1 "Pediatric Cardiac Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.")[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#full-view-affiliation-4 "Dina Reccanati School of Medicine, Reichman University, Herzliya, Israel."), [Sigal Nakav](https://pubmed.ncbi.nlm.nih.gov/?term=Nakav+S&cauthor_id=42687681)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#full-view-affiliation-5 "Coagulation and Hemostasis Laboratory, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel."), [Ofer Schiller](https://pubmed.ncbi.nlm.nih.gov/?term=Schiller+O&cauthor_id=42687681)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#full-view-affiliation-1 "Pediatric Cardiac Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#full-view-affiliation-2 "Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel."), [Joanne Yacobovich](https://pubmed.ncbi.nlm.nih.gov/?term=Yacobovich+J&cauthor_id=42687681)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#full-view-affiliation-2 "Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.")[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#full-view-affiliation-3 "Rina Zaizov Department of Pediatric Hematology-Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.") Affiliations Expand ### Affiliations * 1 Pediatric Cardiac Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. * 2 Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel. * 3 Rina Zaizov Department of Pediatric Hematology-Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. * 4 Dina Reccanati School of Medicine, Reichman University, Herzliya, Israel. * 5 Coagulation and Hemostasis Laboratory, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel. * PMID: **42687681** * DOI: [ 10.1002/1545-5017.70638 ](https://doi.org/10.1002/1545-5017.70638) Item in Clipboard # Safety and Effectiveness of a High-Dose, Tailored Tissue Plasminogen Activator Therapy Protocol: A Joint Pediatric Hematology and Cardiac ICU Quality Improvement Initiative Analysis Eran Shostak et al. Pediatr Blood Cancer. 2026. Show details Display options Display options Format Abstract PubMed PMID Pediatr Blood Cancer Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Pediatr+Blood+Cancer%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Pediatr+Blood+Cancer%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42687681/) . 2026 Sep 3:e70638. doi: 10.1002/1545-5017.70638. Online ahead of print. ### Authors [Eran Shostak](https://pubmed.ncbi.nlm.nih.gov/?term=Shostak+E&cauthor_id=42687681)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#short-view-affiliation-1 "Pediatric Cardiac Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#short-view-affiliation-2 "Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel."), [Oded Gilad](https://pubmed.ncbi.nlm.nih.gov/?term=Gilad+O&cauthor_id=42687681)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#short-view-affiliation-2 "Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.")[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#short-view-affiliation-3 "Rina Zaizov Department of Pediatric Hematology-Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel."), [Yael Feinstein](https://pubmed.ncbi.nlm.nih.gov/?term=Feinstein+Y&cauthor_id=42687681)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#short-view-affiliation-1 "Pediatric Cardiac Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.")[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#short-view-affiliation-4 "Dina Reccanati School of Medicine, Reichman University, Herzliya, Israel."), [Sigal Nakav](https://pubmed.ncbi.nlm.nih.gov/?term=Nakav+S&cauthor_id=42687681)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#short-view-affiliation-5 "Coagulation and Hemostasis Laboratory, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel."), [Ofer Schiller](https://pubmed.ncbi.nlm.nih.gov/?term=Schiller+O&cauthor_id=42687681)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#short-view-affiliation-1 "Pediatric Cardiac Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#short-view-affiliation-2 "Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel."), [Joanne Yacobovich](https://pubmed.ncbi.nlm.nih.gov/?term=Yacobovich+J&cauthor_id=42687681)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#short-view-affiliation-2 "Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.")[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42687681/#short-view-affiliation-3 "Rina Zaizov Department of Pediatric Hematology-Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.") ### Affiliations * 1 Pediatric Cardiac Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. * 2 Gray Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel. * 3 Rina Zaizov Department of Pediatric Hematology-Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. * 4 Dina Reccanati School of Medicine, Reichman University, Herzliya, Israel. * 5 Coagulation and Hemostasis Laboratory, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel. * PMID: **42687681** * DOI: [ 10.1002/1545-5017.70638 ](https://doi.org/10.1002/1545-5017.70638) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Background:** Pediatric thromboembolism is increasingly encountered in critical care. Systemic thrombolysis with tissue plasminogen activator (tPA) facilitates vessel or valve patency, yet pediatric-specific protocols remain undefined, and safety concerns persist. **Objective:** To evaluate the efficacy and safety of a tailored, prolonged systemic tPA protocol for vessel thrombosis and mechanical valve obstruction in infants and children, and to characterize D-dimer kinetics by indication. **Methods:** This retrospective cohort study was performed in a tertiary pediatric cardiac ICU (from July 2014 to March 2024). Extracted data included demographics, tPA dosing, laboratory trends, transfusion requirements, imaging-confirmed success, and adverse events. D-dimer trajectories were analyzed using Welch's t-test. **Results:** Twenty-two patients received systemic tPA during the study period. Median age was 287 days (IQR: 64.8-940); 32% were less than 90 days old. Indications included stuck mechanical valve (n = 10), central venous thrombosis with chylothorax (n = 7), large venous thrombosis (n = 3), coronary thrombosis (n = 1), and arterial ischemic stroke (n = 1). Median initial tPA dose was 0.1 mg/kg/h (IQR: 0.06-0.1), with escalation up to 0.5 mg/kg/h in selected cases; mean treatment duration was 3.9 ± 2.8 days. Valve mobility was restored in 80%. Complete thrombus resolution was achieved in all venous, coronary, and stroke cases. Minor bleeding occurred in 23%; one subdural hemorrhage (5%) was observed. All patients survived to discharge. D-dimer kinetics differed significantly between vessel thrombosis and mechanical valve obstruction (p < 0.01), demonstrating distinct fibrinolytic profiles. **Conclusions:** Tailored prolonged systemic tPA appears effective with minimal adverse effects when administered under strict monitoring. Distinct D-dimer patterns may aid treatment guidance. Multicenter studies are needed to validate standardized pediatric protocols. **Keywords:** thrombolysis; thrombosis; tissue plasminogen activator. © 2026 The Author(s). Pediatric Blood & Cancer published by Wiley Periodicals LLC. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## References 1. 1. C. Tarango and M. J. Manco‐Johnson, “Pediatric Thrombolysis: A Practical Approach,” Frontiers in Pediatrics 5 (2017): 260. 2. 1. L. Raffini, “Thrombolysis for Intravascular Thrombosis in Neonates and Children,” Current Opinion in Pediatrics 21 (2009): 9–14. 3. 1. T. M. Giglia, M. P. Massicotte, J. S. Tweddell, et al., “Prevention and Treatment of Thrombosis in Pediatric and Congenital Heart Disease: A Scientific Statement From the American Heart Association,” Circulation 128 (2013): 2622–2703. 4. 1. A. A. Gupta, M. Leaker, M. Andrew, et al., “Safety and Outcomes of Thrombolysis With Tissue Plasminogen Activator for Treatment of Intravascular Thrombosis in Children,” Jornal de Pediatria 139 (2001): 682–688. 5. 1. G. M. Woods, D. W. Kim, M. L. Paden, and H. K. Viamonte, “Thrombolysis in Children: A Case Report and Review of the Literature,” Frontiers in Pediatrics 9 (2022): 814033. 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