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Fresh-frozen plasma shows no protective effect against intraventricular hemorrhage in preterm infantsTrial Shows Fresh Frozen Plasma Does Not Prevent Brain Bleeding

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Key Takeaway
Interpret with caution: fresh-frozen plasma showed no protective effect on IVH in preterm infants; avoid practice change.

This retrospective target trial emulation assessed whether fresh-frozen plasma transfusion reduces intraventricular hemorrhage in preterm infants (gestational age ≤34 weeks) with prolonged activated partial thromboplastin time (≥70 s). The study included 748 infants at Daping Hospital. The intervention was fresh-frozen plasma transfusion; the comparator was not reported. The primary outcome was intraventricular hemorrhage. Follow-up duration was not reported.

The main analysis found no overall estimated protective effect of fresh-frozen plasma on intraventricular hemorrhage (odds ratio approximately 1, p > 0.4). Absolute event numbers were not reported. No secondary outcomes were specified. Safety data, including adverse events, serious adverse events, discontinuations, and tolerability, were not reported.

Key limitations include the retrospective nature of the data. The study used causal forest analysis within a target trial emulation framework to estimate causal effects, but this design cannot fully control for unmeasured confounding. Funding and conflicts of interest were not reported. Practice relevance was not stated.

Given the lack of observed benefit and the retrospective design, these findings do not support a change in clinical practice regarding fresh-frozen plasma transfusion for this population. The results should be interpreted cautiously, and prospective randomized trials are needed to clarify any potential role.

How this fits prior evidence

This target trial emulation found no protective effect of fresh-frozen plasma on intraventricular hemorrhage in preterm infants, contrasting with prior coverage of TEG-ROTEM guided transfusion in cardiac surgery, where evidence was very uncertain but suggested possible reductions in mortality and bleeding. It also differs from the brodifacoum poisoning case, where rapid reversal of coagulopathy was critical for a life-threatening complication. Unlike the sepsis-induced coagulopathy study that identified statistical associations without clinical utility, this analysis directly estimated a causal effect and found none. Together, these findings highlight the need for prospective trials to establish benefit before adopting transfusion strategies.

Researchers looked at the effects of fresh-frozen plasma on 748 preterm infants. These infants were born at 34 weeks or earlier and had a specific blood clotting condition known as coagulopathy. The goal was to see if receiving a plasma transfusion helped prevent intraventricular hemorrhage, which is a type of bleeding in the brain.

The results showed no overall protective effect from the plasma treatment. The data indicated that the treatment did not significantly change the risk of bleeding for these infants. Because this was a retrospective study, the results are based on past records rather than a controlled, forward-looking trial.

It is important to note that this study is not a randomized controlled trial. While the analysis used specific methods to estimate cause, the findings are based on historical data. Patients and families should discuss these findings with their medical team to understand how they apply to specific cases of neonatal care.

What this means for you:
The study found no evidence that fresh-frozen plasma prevents brain bleeding in preterm infants with coagulopathy.

Common questions

Does fresh-frozen plasma help prevent brain bleeding in preterm infants?

The study of 748 preterm infants found no overall estimated protective effect from fresh-frozen plasma transfusions. The results showed that the treatment did not significantly change the risk of intraventricular hemorrhage in infants with coagulopathy. You should speak with a doctor to understand how this applies to specific medical cases.

Who was included in this study?

The study included 748 preterm infants who were born at a gestational age of 34 weeks or less. These infants also had a prolonged activated partial thromboplastin time of 70 seconds or more, which is a sign of a blood clotting condition called coagulopathy.

How reliable are these findings for clinical practice?

The study used a target trial emulation to estimate effects, but it was based on retrospective data. Because it was not a prospective randomized controlled trial, the results should be viewed as one piece of evidence rather than a definitive guide for immediate changes in medical practice.

Study Details

Study typeRct
EvidenceLevel 2
PublishedSep 2026
View Original Abstract ↓
BackgroundCoagulopathy is a common risk factor in the occurrence of intraventricular hemorrhage (IVH) and subsequent poor neurological outcomes in preterm infants. The causal effect of fresh-frozen plasma (FFP) transfusion and IVH needed to be identified urgently.MethodsWithin the framework of target trial emulation (TTE), we mimic the process of a randomized controlled trial based on retrospective neonatal clinical data collected at Daping Hospital from 2015 to 2025, ultimately including 748 preterm infants with gestational age ≤34 weeks and prolonged activated partial thromboplastin time ≥70 s. Multiple causal inference models were conducted to minimize confounding and covariate imbalance, including inverse probability weighting with generalized boosted models (GBM-IPW) method, GBM-doubly robust (GBM-DR) estimation, covariate balancing propensity score (CBPS) model and other sensitivity analyses. Causal forests algorithm further triangulated the main results and explore individual-level heterogeneity and key determinants about FFP.ResultsAll causal models consistently demonstrated that FFP transfusion exerted no overall estimated protective effect against IVH (all odds ratio (OR) ≈ 1; p > 0.4). GA was found a protective factor of IVH and modified the effect of FFP transfusion (p 
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