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Clinical equipoise on prophylaxis against catheter-associated thrombosis in critically ill children
Candace N Mannarino1, Edward Vincent S Faustino2
1Yale-New Haven Hospital, New Haven, CT 06510.
Insights
Pediatric critical care physicians show willingness to randomize children for studies on preventing catheter-associated deep vein thrombosis. This clinical equipoise supports initiating randomized controlled trials for prophylaxis in critically ill children.
Area of Science:
- Pediatric critical care medicine
- Vascular thrombosis research
- Clinical trial ethics
Background:
- Catheter-associated deep venous thrombosis (DVT) is a significant concern in critically ill children.
- Prophylaxis strategies require rigorous evaluation through randomized controlled trials (RCTs).
- Establishing clinical equipoise is essential before initiating RCTs.
Purpose of the Study:
- To determine clinical equipoise among pediatric critical care physicians regarding randomization for DVT prophylaxis.
- To assess physician willingness to randomize critically ill children based on specific clinical factors.
Main Methods:
- A cross-sectional electronic survey was administered to US pediatric critical care physicians.
- Physicians' willingness to randomize was evaluated based on child's age, catheter presence, and risk factors (coagulopathy, recent surgery, bleeding).
Main Results:
- Responses from 239 physicians indicated willingness to randomize children aged 1 month+ with a catheter.
- Willingness to randomize without a catheter was limited to children over 13 years.
- Specific criteria for coagulopathy, surgery, and bleeding were defined for randomization.
Conclusions:
- Clinical equipoise exists among pediatric critical care physicians for DVT prophylaxis trials.
- This equipoise ethically supports the initiation of RCTs for catheter-associated thrombosis prophylaxis in critically ill children.
Purpose:
In preparation for a randomized controlled trial of prophylaxis against catheter-associated deep venous thrombosis in critically ill children, we aimed to determine clinical equipoise, defined as willingness to randomize children, among pediatric critical care physicians.
Materials And Methods:
We conducted a cross-sectional, self-administered electronic survey of pediatric critical care physicians in the United States. The survey focused on the effect of child's age, presence of a central venous catheter, and risk (ie, presence of coagulopathy or recent surgery) and presence of bleeding on their willingness to randomize children to an anticoagulant or placebo.
Results:
Responses from 239 (33.0%) of 725 physicians were analyzed. Respondents were willing to randomize children 1 month or older in the presence of a catheter but only those older than 13 years in the absence of a catheter. For children with coagulopathy, they would randomize those with international normalized ratio less than or equal to 2.0, partial thromboplastin time less than or equal to 50 seconds, and platelet count greater than or equal to 50000/mm(3). Respondents were willing to randomize children 2 days after most types of surgery and after 1 to 5 days of a bleeding event.
Conclusions:
Clinical equipoise on prophylaxis against catheter-associated thrombosis exists among pediatric critical care physicians, which ethically justifies conducting a randomized controlled trial.
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