A clinical pilot study of fresh frozen plasma versus human albumin in paediatric craniofacial repair

Paediatric craniofacial surgery (pCFS) regularly requires transfusion of packed red blood cells (pRBC). In this clinical pilot study two different transfusion regimens were prospectively compared concerning pRBC transfusions, postoperative bleeding and other clinical parameters. Thirty infants (aged < 12 months) scheduled for pCFS were assigned to receive fresh frozen plasma (FFP-group, n = 15) or 5% human albumin (HA-group, n = 15) during the entire surgical procedure. Perioperative amounts of pRBC, postoperative bleeding, major complications, duration of stay in the intensive care unit and overall hospital stay were compared. Differences in pRBC transfusions, postoperative bleeding, and duration of intensive care unit stay were not significant and no major complications occurred in either group. A significantly shorter overall hospital stay was observed in favour of the FFP-group. Volume replacement during pCFS can be safely performed with both applied protocols. Our data do not demonstrate a major advantage for FFP use, but further evaluation is necessary.     

Composition of fresh frozen plasma

We analyzed 35 samples of fresh frozen plasma (FFP), finding mean concentrations of 535 mg/dl glucose, 172 mEq/L sodium, 73 mEq/L chloride, 3.5 mEq/L potassium, 15 mEq/L bicarbonate, and 5.5 g/dl protein with 60% albumin. Thus, FFP is a hyperosmolal, hyperglycemic, hypernatremic, and hypochloremic solution which may be a less effective volume expander than other albumin-containing solutions, due to its lower albumin content.     

Pre-hospital freeze-dried plasma for critical bleeding after trauma: A pilot randomized controlled trial

Objectives

Transfusion of a high ratio of plasma to packed red blood cells (PRBCs), to treat or prevent acute traumatic coagulopathy, has been associated with survival after major trauma. However, the effect of prehospital plasma on patient outcomes has been inconsistent. The aim of this pilot trial was to assess the feasibility of transfusing freeze-dried plasma with red blood cells (RBCs) using a randomized controlled design in an Australian aeromedical prehospital setting.

Methods

Patients attended by helicopter emergency medical service (HEMS) paramedics with suspected critical bleeding after trauma managed with prehospital RBCs were randomized to receive 2 units of freeze-dried plasma (Lyoplas N-w) or standard care (no plasma). The primary outcome was the proportion of eligible patients enrolled and provided the intervention. Secondary outcomes included preliminary data on effectiveness, including mortality censored at 24 h and at hospital discharge, and adverse events.

Results

During the study period of June 1 to October 31, 2022, there were 25 eligible patients, of whom 20 (80%) were enrolled in the trial and 19 (76%) received the allocated intervention. Median time from randomization to hospital arrival was 92.5 min (IQR 68–101.5 min). Mortality may have been lower in the freeze-dried plasma group at 24 h (RR 0.24, 95% CI 0.03–1.73) and at hospital discharge (RR 0.73, 95% CI 0.24–2.27). No serious adverse events related to the trial interventions were reported.

Conclusions

This first reported experience of freeze-dried plasma use in Australia suggests prehospital administration is feasible. Given longer prehospital times typically associated with HEMS attendance, there is potential clinical benefit from this intervention and rationale for a definitive trial.     

Optimal use of fresh frozen plasma

Fresh frozen plasma contains a number of therapeutically useful substances, most notably coagulation factors. As with any transfusion, there are risks associated with plasma transfusion. Ironically, the risk of viral transmission (human immunodeficiency virus or hepatitis), although widely publicized, is extremely small. On the other hand, less well-known, noninfectious complications are common. Indeed, these noninfectious complications are the most significant cause of morbidity and mortality following transfusion. Although certain patients undeniably benefit from plasma transfusion, the benefit for many patients is less clear. This review will discuss indications for plasma transfusion, the associated risks, and special considerations for plasma administration.     

French lyophilized plasma versus fresh frozen plasma for the initial management of trauma‐induced coagulopathy: a randomized open‐label trial

Essentials

• An immediate supply of plasma in case of trauma‐induced coagulopathy is required.
• The Traucc trial compared French Lyophilised Plasma (FLyP) and Fresh Frozen Plasma (FFP).
• FLyP achieved higher fibrinogen concentrations compared with FFP.
• FLyP led to a more rapid coagulopathy improvement than FFP.

Summary

Background

Guidelines recommend beginning hemostatic resuscitation immediately in trauma patients. We aimed to investigate if French lyophilized plasma (FLyP) was more effective than fresh frozen plasma (FFP) for the initial management of trauma‐induced coagulopathy.

Methods

In an open‐label, phase 3, randomized trial (NCT02750150), we enrolled adult trauma patients requiring an emergency pack of 4 plasma units within 6 h of injury. We randomly assigned patients to receive 4‐FLyP units or 4‐FFP units. The primary endpoint was fibrinogen concentration at 45 min after randomization. Secondary outcomes included time to transfusion, changes in hemostatic parameters at different time‐points, blood product requirements and 30‐day in‐hospital mortality.

Results

Forty‐eight patients were randomized (FLyP, n = 24; FFP, n = 24). FLyP reduced the time from randomization to transfusion of first plasma unit compared with FFP (median[IQR],14[5–30] vs. 77[64–90] min). FLyP achieved a higher fibrinogen concentration 45 min after randomization compared with FFP (baseline‐adjusted mean difference, 0.29 g L^?1; 95% confidence interval [CI], 0.08–0.49) and a greater improvement in prothrombin time ratio, factor V and factor II. The between‐group differences in coagulation parameters remained significant at 6 h. FLyP reduced fibrinogen concentrate requirements. Thirty‐day in‐hospital mortality rate was 22% with FLyP and 29% with FFP.

Conclusion

FLyP led to a more rapid, pronounced and extended increase in fibrinogen concentrations and coagulopathy improvement compared with FFP in the initial management of trauma patients. FLyP represents an attractive option for trauma management, especially when facing logistical issues such as combat casualties or mass casualties related to terror attacks or disasters.

     

2种方法制备冷沉淀的质量分析

目的通过对冷藏融化法和水浴融化法制备冷沉淀的质量分析,选择合适的制备冷沉淀的方法。方法随机抽取2006年前后采用冷藏融化法和水浴融化法制备的冷沉淀各60份;利用血凝仪检测冷沉淀中FⅧ和Fg的含量,并计算FⅧ和Fg的合格率。结果冷藏融化法和水浴融化法的FⅧ含量(IU/袋)分别为:70.30±23.68,161.62±39.45;FⅧ合格率分别为:43.33%(26/60),93.33%(56/60),两者比较均有统计学差异(P<0.001)。Fg的含量(mg/袋)分别为:222.72±63.75,228.12±66.83;Fg合格率分别为:88.33%(53/60),91.67%(55/60),两者比较均无统计学差异(P>0.05)。结论水浴融化法制备冷沉淀简便、快速,Ⅷ合格率高,明显优于冷藏融化法,值得推广应用。     

去白细胞输血器对新鲜冰冻血浆中凝血因子的影响

目的　探讨经白细胞过滤器过滤后的新鲜冰冻血浆 ( fresh frozen plasma,FFP)中凝血因子的生物活性变化。方法　随机抽取 A型、B型、O型、AB型新鲜冰冻血浆各 1 0 0 ml× 5袋 ,3 7℃水浴融化 ,在净化台内留取滤过前后血浆样本各 1 ml,使用德国 BE全自动血凝仪测定活化部分凝血酶时间 ( APTT)、凝血酶原时间 ( PT)、凝血酶时间 ( TT)、纤维蛋白原( Fbg)、凝血因子 ( F ∶C)、凝血因子 ( F ∶C)、凝血因子 ( F C)∶水平。结果　过滤前后的新鲜冰冻血浆 APTT、PT、TT、F ∶ C、F ∶ C、Fbg水平的差异均无显著性 ( P>0 .0 5 )。 F ∶ C过滤前后的差异有显著性 ( P<0 .0 5 ) ,但仍在参考值范围内。结论　过滤前后新鲜冰冻血浆中凝血因子的活性差异变化在参考值范围内 ,适用于临床治疗     

A randomized trial on the effect of isotonic amino acid infusion on postoperative complications and short life plasma protein concentrations

In a randomized clinical study 30 patients with high risk surgical procedures were distributed to receive either standard fluid-therapy (n = 14) or an isotonic amino acid solution (n = 16) during five days. The patients were evaluated pre- and postoperatively using: anthropometric parameters: body weight, biceps and triceps skinfold thickness, and mid arm circumference; biochemical parameters: albumin, prealbumin, transferrin, retinol-binding protein, total iron-binding capacity, and cholesterol; and delayed cutaneous hypersensitivity. Clinical outcome and complications were also recorded. Positive ketonuria was obtained soon in the treatment group after 24 h. Mean daily nitrogen balance was better in the protein sparing group (-3.8 g vs -9.3 g) p less than 0.02. No differences were observed between both groups in the postoperative plasma protein levels. There were no significant differences in delayed cutaneous reactivity nor anthropometric parameters between both groups; and mortality and morbidity were similar. The present study lends little support for substituting the routine D5W and saline postoperative fluid regime. No clinical advantage of amino acids over standard fluids could be appreciated indicating that the much less expensive conventional solutions should not be replaced by amino acids, at least in routine postoperative cases.     

Evaluation of the effect of Benson's relaxation technique on pain and quality of life of haemodialysis patients: A randomized controlled trial

Background

Haemodialysis patients may suffer from pain and impairment of quality of life. Some complementary interventions, such as relaxation therapy, might affect the pain and quality of life. The present study aimed to identify the effectiveness of Benson's relaxation technique in relieving pain and improving the quality of life in haemodialysis patients.

Study design

The study was a randomized controlled trial.

Setting and participants

The data were collected in two haemodialysis units affiliated to Shiraz University of Medical Sciences. A total of 86 haemodialysis patients were randomly assigned to either the intervention (receiving Benson's relaxation technique) or the control group (routine care) from 2011 to 2012.

Intervention

The patients in the intervention groups listened to the audiotape of relaxation technique twice a day each time for 20 min for eight weeks.

Measurements and outcomes

The pain numeric rating scale and Ferrans and Powers Quality of Life Index-dialysis version questionnaire were completed at baseline and 8 weeks after the intervention. The data were analyzed using independent t-test and ANCOVA.

Results

The results of ANCOVA showed a significant difference between the intervention and the control group concerning the mean score of the intensity of pain (F = 6.03, p = 0.01). Moreover, a significant difference was found between the intervention and the control group regarding the total quality of life (F = 10.20, p = 0.002) and health-functioning (F = 8.64, p = 0.004), socioeconomic (F = 12.45, p = 0.001), and family (F = 8.52, p = 0.005) subscales of quality of life.

Conclusion

These findings indicated that Benson's relaxation technique might relieve the intensity of pain and improve the quality of life in haemodialysis patients. Thus, Benson's relaxation technique could be used as part of the care practice for relieving the pain intensity and improvement of the quality of life in haemodialysis patients.     

Evaluation of appropriate usage of fresh frozen plasma: Results of a regional audit in Iran

BackgroundFresh frozen plasma (FFP) is a major source of coagulation factor replacement therapy for patients with clotting factor deficiency. Although FFP is readily available for use in clinical practice its administration isn’t without risk. Studies on the use of FFP reveal that it is often overused or inappropriately used. We undertook an audit to assess the appropriateness of FFP transfusion in Gorgan’s hospitals.MethodsThis was a retrospective, audit done at 5 hospitals in Gorgan city regarding the use of 1592 units of FFP issued to 346 patients from March 2006 to March 2007. The appropriateness of FFP transfusion was analyzed according to British Council for Standardization in Hematology (BCSH) Guidelines 2004.ResultsIn this audit we identified a high rate of inappropriate FFP usage (53% of transfusion episodes). Most ‘Inappropriate’ FFP usage occurred when there was active bleeding, with normal (or unmeasured) coagulation tests (30% of transfusion episodes). In only 66% of FFP-transfused patients were coagulation variable measured at any point in the hospital episode.ConclusionInappropriate usage of FFP is often seen in medical facility and the right solution is needed to curb the misuse of this component. Regular utilization audit can identify correctable errors in transfusion practices. Formal education programs and existing information on FFP use should be directed to professionals ordering FFP.     

Guidelines for the use of fresh frozen plasma

Fresh frozen plasma should only be used to treat bleeding episodes or prepare patients for surgery in certain defined situations. Definite indications for the use of FFP: 1. Replacement of single coagulation factor deficiencies, where a specific or combined factor concentrate is unavailable. 2. Immediate reversal or warfarin effect. 3. Acute disseminated intravascular coagulation (DIC). 4. Thrombotic thrombocytopenic purpura (TTP). Conditional uses: FFP only indicated in the presence of bleeding and disturbed coagulation: 1. Massive transfusion. 2. Liver disease. 3. cardiopulmonary bypass surgery. 4. Special paediatric indications. No justification for the use of FFP: 1. Hypovolaemia. 2. Plasma exchange procedures. 3. 'Formula' replacement. 4. Nutritional support. 5. Treatment of immunodeficiency states.     

Effect of transfusion of fresh frozen plasma on parameters of endothelial condition and inflammatory status in non-bleeding critically ill patients: a prospective substudy of a randomized trial

IntroductionMuch controversy exists on the effect of a fresh frozen plasma (FFP) transfusion on systemic inflammation and endothelial damage. Adverse effects of FFP have been well described, including acute lung injury. However, it is also suggested that a higher amount of FFP decreases mortality in trauma patients requiring a massive transfusion. Furthermore, FFP has an endothelial stabilizing effect in experimental models. We investigated the effect of fresh frozen plasma transfusion on systemic inflammation and endothelial condition.MethodsA prospective predefined substudy of a randomized trial in coagulopathic non-bleeding critically ill patients receiving a prophylactic transfusion of FFP (12 ml/kg) prior to an invasive procedure. Levels of inflammatory cytokines and markers of endothelial condition were measured in paired samples of 33 patients before and after transfusion. The statistical tests used were paired t test or the Wilcoxon signed-rank test.ResultsAt baseline, systemic cytokine levels were mildly elevated in critically ill patients. FFP transfusion resulted in a decrease of levels of TNF-α (from 11.3 to 2.3 pg/ml, P = 0.01). Other cytokines were not affected. FFP also resulted in a decrease in systemic syndecan-1 levels (from 675 to 565 pg/ml, P = 0.01) and a decrease in factor VIII levels (from 246 to 246%, P <0.01), suggestive of an improved endothelial condition. This was associated with an increase in ADAMTS13 levels (from 24 to 32%, P <0.01) and a concomitant decrease in von Willebrand factor (vWF) levels (from 474 to 423%, P <0.01).ConclusionsA fixed dose of FFP transfusion in critically ill patients decreases syndecan-1 and factor VIII levels, suggesting a stabilized endothelial condition, possibly by increasing ADAMTS13, which is capable of cleaving vWF.

Trial registrations

Trialregister.nl NTR2262, registered 26 March 2010 and Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01143909","term_id":"NCT01143909"}}NCT01143909, registered 14 June 2010.