Liofilizirana plazma za velike traume - Sistematski pregled i meta-analiza.
The journal of trauma and acute care surgery
Sažetak istraživanja
Pozadina Tretman akutne traumatske koagulopatije se pomjerio prema brzoj zamjeni faktora koagulacije smrznutom plazmom (FP). Postoje logističke poteškoće u pružanju FP. Liofilizirana plazma (FDP) može imati logističke prednosti uključujući lakše skladištenje i brzo vrijeme pripreme. Ovaj pregled procjenjuje izvodljivost, efikasnost i sigurnost FDP-a u traumi.
Dizajn i metode studije Studije su pretražene iz Medline, Embase, Cochrane Controlled Trials Register, ClinicalTrials.gov i Google Scholar. Uključene su opservacijske i randomizirane kontrolirane studije (RCT) koje procjenjuju upotrebu FDP-a u traumi. Uključeni su i životinjski modeli traume koji se bave upotrebom FDP-a. Pristrasnost je procijenjena korištenjem validiranih alata. Primarni ishod je bila efikasnost, a sekundarni ishodi bili su izvodljivost i sigurnost. Meta-analize su provedene korištenjem modela slučajnog efekta. Dokazi su ocijenjeni korištenjem profila ocjenjivanja, razvoja i evaluacije preporuka.
Rezultati Uključeno je dvanaest studija na ljudima (RCT, 1; opservacijski, 11) i 15 studija na životinjama. Sve u svemu, studije su pokazale umjeren rizik od pristrasnosti. Podaci iz dvije studije (n = 119) kombinovani su za meta-analize mortaliteta i transfuzije alogenih krvnih produkata (ABP). Za oba ishoda nije utvrđena razlika. Za mortalitet, omjer objedinjene šanse je bio 0,66 (95% interval pouzdanosti, 0,29-1,49), sa I2 = 0%. Upotreba FDP-a je izvodljiva i nisu prijavljeni neželjeni događaji. Podaci na životinjama sugeriraju slične rezultate za koagulacijski i protuupalni profil za FP i FDP.
Zaključak Ljudski podaci koji procjenjuju upotrebu FDP u traumi ne pokazuju razliku u mortalitetu i transfuziji ABP kod pacijenata koji primaju FDP u poređenju sa FP. Podaci iz studija traume na životinjama pokazuju da nema razlike u faktoru koagulacije i protuupalnim profilima između FP i FDP. Rezultate treba tumačiti s oprezom jer je većina studija bila opservacijska i ima heterogenu populaciju (vojne i civilne traume) i umjeren rizik od pristranosti. Dobro osmišljene prospektivne opservacijske studije ili, preferencijalno, RCT-ovi su opravdani da odgovore na učinak FDP-a na laboratorijski (nivoi faktora koagulacije), transfuziju (broj ABP) i kliničke ishode (disfunkcija organa, dužina boravka i smrtnost). Nivo dokaza Sistematski pregled i meta-analiza, nivo IV.
Prikaži originalni naslov i sažetak na engleskom
Freeze-dried plasma for major trauma - Systematic review and meta-analysis.
Background Treatment of acute trauma coagulopathy has shifted toward rapid replacement of coagulation factors with frozen plasma (FP). There are logistic difficulties in providing FP. Freeze-dried plasma (FDP) may have logistical advantages including easier storage and rapid preparation time. This review assesses the feasibility, efficacy, and safety of FDP in trauma. Study design and methods Studies were searched from Medline, Embase, Cochrane Controlled Trials Register, ClinicalTrials.gov, and Google Scholar. Observational and randomized controlled trials (RCTs) assessing FDP use in trauma were included. Trauma animal models addressing FDP use were also included. Bias was assessed using validated tools. Primary outcome was efficacy, and secondary outcomes were feasibility and safety. Meta-analyses were conducted using random-effect models. Evidence was graded using Grading of Recommendations Assessment, Development, and Evaluation profile.
Results Twelve human studies (RCT, 1; observational, 11) and 15 animal studies were included. Overall, studies demonstrated moderate risk of bias. Data from two studies (n = 119) were combined for meta-analyses for mortality and transfusion of allogeneic blood products (ABPs). For both outcomes, no difference was identified. For mortality, pooled odds ratio was 0.66 (95% confidence interval, 0.29-1.49), with I2 = 0%. Use of FDP is feasible, and no adverse events were reported. Animal data suggest similar results for coagulation and anti-inflammatory profiles for FP and FDP.
Conclusion Human data assessing FDP use in trauma report no difference in mortality and transfusion of ABPs in patients receiving FDP compared with FP. Data from animal trauma studies report no difference in coagulation factor and anti-inflammatory profiles between FP and FDP.
Results should be interpreted with caution because most studies were observational and have heterogeneous population (military and civilian trauma) and a moderate risk of bias. Well-designed prospective observational studies or, preferentially, RCTs are warranted to answer FDP's effect on laboratory (coagulation factor levels), transfusion (number of ABPs), and clinical outcomes (organ dysfunction, length of stay, and mortality). Level of evidence Systematic review and meta-analysis, level IV.
Izvorni podaci
- DOI
- 10.1097/ta.0000000000003012
- PMID
- 33507025
- PMCID
- PMC7899224
- Provjereno
- 2026-07-26
Naslov i sažetak prevedeni su automatski i prijevod može sadržavati netačnosti ili neprecizne stručne izraze. Za sve detalje, citiranje i medicinsko tumačenje pregledajte originalnu englesku verziju članka. Ne donosite zdravstvene odluke samo na osnovu ovog prijevoda.
Pregledaj originalni članak na engleskom