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Safety and efficacy of danaparoid (Orgaran) use in children
Christoph Bidlingmaier1, Harry N Magnani, Monika Girisch
1Department of Paediatric Haemostaseology, Dr. von Hauner's University Children's Hospital, Munich, Germany. christoph.bidlingmaier@med.uni-muenchen.de
Insights
Danaparoid is a viable alternative anticoagulant for children with heparin-induced thrombocytopenia (HIT), a serious heparin complication. While generally safe, caution is advised for pediatric patients undergoing cardiopulmonary bypass surgery.
Area of Science:
- Pediatric Hematology
- Pharmacology
- Thrombosis
Background:
- Immune-mediated heparin-induced thrombocytopenia (HIT) is a rare but severe complication of heparin therapy.
- Limited data exists on alternative antithrombotic treatments for pediatric HIT patients.
- Children with HIT often have complex underlying conditions increasing thrombotic and bleeding risks.
Purpose of the Study:
- To review the efficacy and safety of danaparoid as an alternative anticoagulant in pediatric patients with HIT.
- To evaluate danaparoid dosing and outcomes in children with HIT.
Main Methods:
- A review of 27 published and 7 unpublished case reports of children (2 weeks to 17 years) treated with danaparoid.
- Analysis of HIT diagnosis confirmation, danaparoid regimens, and patient outcomes, including survival and adverse events.
Main Results:
- Danaparoid was used in 33 children with confirmed or suspected HIT and one child at high bleeding risk.
- HIT was serologically or clinically confirmed in 78.8% of cases.
- Younger children generally required higher danaparoid doses to reach target anti-Xa levels.
- Survival rate was 84.8% (28/33), with 7 serious adverse events and 5 deaths (including 1 thrombotic and 2 major bleeds).
- Major bleeding events were more frequent in children undergoing cardiopulmonary bypass surgery.
Conclusions:
- Danaparoid can be an effective alternative antithrombotic for pediatric patients intolerant to heparins.
- Its use should be carefully considered in children requiring cardiopulmonary bypass surgery due to increased bleeding risk.
- Danaparoid offers a treatment option for HIT in children, but requires careful dosing and monitoring.
Abstract:
Immune-mediated heparin-induced thrombocytopenia (HIT) is an uncommon but serious complication of therapy with heparins. It affects all ages and requires replacement of the causative anticoagulant. However, information on alternative antithrombotic use in children with HIT is limited. This paper reviews 27 published and 7 unpublished case reports of children aged 2 weeks to 17 years treated with danaparoid. Thirty-three suffered from HIT or suspected HIT, and 1 child without HIT had a high bleeding risk. All children had severe underlying problems increasing their thrombotic and/or bleeding risk. HIT diagnosis was confirmed serologically or clinically in 26 cases (78.8%). Danaparoid regimens were similar to those used in adults, but in general, younger children needed higher daily doses of danaparoid to achieve the same target plasma anti-Xa levels than teenagers or adults. Of those with a known outcome 28/33 children (84.8%) survived, 7 having suffered from a serious adverse event. Five deaths occurred including 1 thrombotic and 2 major bleeds. Three of the in total 4 major bleeding events occurred in children undergoing surgery with cardiopulmonary bypass. We conclude that despite the reported adverse events danaparoid can be used as an alternative antithrombotic for children who are intolerant of the heparins, except in cases requiring cardiopulmonary bypass surgery.
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