Evidence map›Paper›PMID 26409798›Full record

Trial reportAnnals of Saudi medicine

Pilot trial of a novel two-step therapy protocol using nebulized tranexamic acid and recombinant factor VIIa in children with intractable diffuse alveolar hemorrhage.

Hind Bafaqih, May Chehab, Suliman Almohaimeed, Farah Thabet, Abdulrahman Alhejaily, Mohammed AlShahrani, Mohammed A Zolaly, Abeer A Abdelmoneim, Ehab S Abd

Open access · diamondAbstract readClinical Trial
In one paragraph

Trial report in Annals of Saudi medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

  1. Antifibrinolytic and Adjunct Hemostatic Agents: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2024
    Pooled it
  2. A breath of fresh air: an updated review of nebulised tranexamic acid for post-tonsillectomy haemorrhage.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
    Review
  3. Review
  4. Management of severe acute pulmonary haemorrhage in children.The Lancet. Child & adolescent health · 2025
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 2 countries.

Hind BafaqihHind Bafaqih, Consultant Pediatric Intensive Care Medicine, Pediatric Intensive Care Unit, Prince Sultan Military Hospital, Riyadh, Saudi Arabia, M: 966555558218, hbafagih13@gmail.com.
May Chehab
Suliman Almohaimeed
Farah Thabet
Abdulrahman Alhejaily
Mohammed AlShahrani
Mohammed A Zolaly
Abeer A Abdelmoneim
Ehab S Abd
Riyadh Armed Forces Hospital · SASohag University · EGMaternity and Children's Hospital · SATaibah University · SA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesDiffuse alveolar hemorrhage (DAH) is a life threatening condition with very limited, often unsuccessful, therapeutic options. This study aimed at exploring the feasibility and efficacy of nebulized tranexamic acid TXA (n-TXA) and nebulized recombinant factor VIIa (n-rFVIIa) when used in a two-step therapy protocol in children with intractable DAH in a pediatric intensive care unit.

methodsIn a prospective trial, n-TXA (250 mg/dose for children < 25 kg and 500 mg/dose for children > 25 kg) was administered to 18 children (median age [interquartile range]; 24.0 months [11.3, 58.5]) with intractable DAH. N-rFVIIa (35 micro g/kg/dose for children < 25 kg, and 50 micro g/kg/dose for children > 25 kg) was added if no or minimal response was seen after 3 to 4 doses (18 to 24 hours) of n-TXA.

resultsDAH was stopped in 10 (55.6%) children with n-TXA alone within 24 hours of therapy. Documented concomitant respiratory infection showed a significant negative association with response to n-TXA in a step.wise regression analysis (OR=0.06; 95% CI=0.01-0.74). In the other 8 (44.4%) children, n-rFVIIa was added due to n-TXA failure. Six (75.0%) showed complete cessation of DAH, while two children failed to respond with the addition of n-rFVIIa (25.0%). None of the children who responded to therapy showed recurrence of DAH after therapy termination. No complications related to therapy were recorded.

conclusionsn-TXA and n-rFVIIa were effective and safe when used in a two-step-therapy protocol to control intractable DAH in pediatric patients in intensive care settings. This therapy modality warrants further exploration through larger multicenter clinical trials.

Indexed as

Pulmonary AlveoliAntifibrinolytic AgentsChild, PreschoolDrug Therapy, CombinationFactor VIIaFeasibility StudiesFemaleHemorrhageHumansInfantIntensive Care Units, PediatricLung DiseasesMaleNebulizers and VaporizersPilot ProjectsProspective StudiesAntifibrinolytic AgentsFactor VIIarecombinant FVIIaRecombinant ProteinsTranexamic Acid

Identifiers

PMID26409798
PMCPMC6074453
OpenAlexW2413727669

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.