Air-drop blood supply in the French Army.

BACKGROUND: Haemorrhagic shock remains the leading cause of preventable death in overseas and austere settings. Transfusion of blood components is critical in the management of this kind of injury. For French naval and ground military units, this supply often takes too long considering the short shelf-life of red blood cell concentrates (RBCs) and the limited duration of transport in cooling containers (five to six days). Air-drop supply could be an alternative to overcome these difficulties on the condition that air-drop does not cause damage to blood units. METHODS: After a period of study and technical development of packaging, four air-drops at medium and high altitudes were performed with an aircraft of the French Air Force. After this, one air-drop was carried out at medium altitude with 10 RBCs and 10 French lyophilised plasma (FLYP). A second air-drop was performed with a soldier carrying one FLYP unit at 12 000 feet. For these air-drops real blood products were used, and quality control testing and temperature monitoring were performed. RESULTS: The temperatures inside the containers were within the normal ranges. Visual inspection indicated that transfusion packaging and dumped products did not undergo deterioration. The quality control data on RBCs and FLYP, including haemostasis, suggested no difference before and after air-drop. DISCUSSION: The operational implementation of the air-drop of blood products seems to be one of the solutions for the supply of blood products in military austere settings or far forward on battlefield, allowing safe and early transfusion.

Rational and design of the T-STORHM Study: A prospective randomized trial comparing fresh whole blood to blood components for acutely bleeding trauma patients.

Massive hemorrhage remains the main cause of preventable death in combat settings and is also the main cause of year loss in developing countries. The management of these patients relies on blood transfusion and surgery. Time is a key factor, related to survival. Recent events highlight the need to be more efficient in the transfusion supply during terror attacks or mass casualties in civilian settings. Blood components therapy with a 1:1:1 ratio is associated with a decrease of mortality but encounters many logistic issues in those circumstances. Whole blood provides in one bag all the blood components in physiologic proportions with minimal amount of additive solution. Whole blood has been implemented in military as well as civilian settings worldwide. However, direct comparisons with component therapy in prospective clinical trials are scarce. Here we present the rational and the design of the T-STORHM (Trauma-Sang TOtal dans les Hémorragies Massives) trial. This prospective randomized multicentric clinical trial will test low titer group O whole blood to components therapy in the in-hospital management of trauma patients with massive hemorrhage. Sample size calculation, primary and secondary endpoints as trial blood products preparations are discussed. The trial is expected to start in 2019 in 6 civilians and military trauma centers. The French Military Health Service is promoting the study in collaboration with the French transfusion public service (Établissementfrançaisdusang).

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.

Early transfusion on battlefield before admission to role 2: A preliminary observational study during "Barkhane" operation in Sahel.

INTRODUCTION: Haemorrage is the leading cause of death after combat related injuries and bleeding management is the cornerstone of management of these casualties. French armed forces are deployed in Barkhane operation in the Sahel-Saharan Strip who represents an immense area. Since this constraint implies evacuation times beyond doctrinal timelines, an institutional decision has been made to deploy blood products on the battlefield and transfuse casualties before role 2 admission if indicated. The purpose of this study was to evaluate the transfusion practices on battlefield during the first year following the implementation of this policy. MATERIALS AND METHODS: Prospective collection of data about combat related casualties categorized alpha evacuated to a role 2. Battlefield transfusion was defined as any transfusion of blood product (red blood cells, plasma, whole blood) performed by role 1 or Medevac team before admission at a role 2. Patients' characteristics, battlefield transfusions' characteristics and complications were analysed. RESULTS: During the one year study, a total of 29 alpha casualties were included during the period study. Twenty-eight could be analysed, 7/28 (25%) being transfused on battlefield, representing a total of 22 transfusion episodes. The most frequently blood product transfused was French lyophilized plasma (FLYP). Most of transfusion episodes occurred during medevac. Compared to non-battlefield transfused casualties, battlefield transfused casualties suffered more wounded anatomical regions (median number of 3 versus 2, p = 0.04), had a higher injury severity score (median ISS of 45 versus 25, p = 0,01) and were more often transfused at role 2, received more plasma units and whole blood units. There was no difference in evacuation time to role 2 between patients transfused on battlefield and non-transfused patients. There was no complication related to battlefield transfusions. Blood products transfusion onset on battlefield ranged from 75 min to 192 min after injury. CONCLUSION: Battlefield transfusion for combat-related casualties is a logistical challenge. Our study showed that such a program is feasible even in an extended area as Sahel-Saharan Strip operation theatre and reduces time to first blood product transfusion for alpha casualties. FLYP is the first line blood product on the battlefield.

Early and repeated use of plasma for the management of Ebola patients: Reflection around a case.

In December 2013, the most widespread epidemic of Ebola virus disease began in Guinea and continued for over 2 years. At the request of the Guinean state, France deployed a military field hospital to treat Ebola infected healthcare workers. From January to July 2015, our center supported 26 healthcare workers suffering from Ebola virus disease. Despite an individualized care and optimal treatment, the fatality rate remained high at 30.7%. Improved therapies are required to reduce mortality risk in Ebola virus disease. We report the case of a patient admitted to the hospital on the 4th day after onset, who survived despite several clinical and biological predictors of fatal outcome. We transfused plasma at a high dose and spread over time. This innovative therapeutic approach was based on our clinical experience of Ebola patients' management, literature review and knowledge of plasma ability to restore coagulation disorders and endotheliopathy. Even without any bleeding sign, coagulopathy and endothelial permeability disorders participate in hypovolemia and fatal multi-system organ failure. Early intake of therapeutic plasma at repeated doses seems to reduce the endothelial permeability and coagulation disorders related to Ebola virus disease.

[Conjunctival dirofilariasis caused by Dirofilaria repens: report of a French case]. / Dirofilariose conjonctivale à Dirofilaria repens: à propos d'un cas français.

Dirofilariasis involving Dirofilaria repens is an exceedingly rare event in France. Most cases have involved subcutaneous lesions but ocular and peri-ocular involvement have been observed. The present report describes a case of dirofilariasis involving the conjunctiva in a 61 year-old-man in France. Onset was characterized by the sudden appearance of painful conjunctival cyst. Clinical examination and laboratory tests did not allow diagnosis. Opening the cyst and extracting the parasite allowed diagnosis and treatment. Microscopic examination identified the parasite as a female Dirofilaria repens. This new case of ocular dirofilariasis emphasizes that this parasitic disease is present and probably underestimated in mainland France. Opening of the conjunctival cyst allowed identification of the parasite and successful treatment without sequels.

[Assessment of malaria screening management in blood donation control in the French Military Blood Institute]. / Évaluation de la stratégie de dépistage du paludisme en qualification biologique du don au CTSA.

The French Military Blood Institute is responsible for the entire blood supply chain in the French Armed Forces. Considering, the high exposition rate of military to malaria risk, blood donation screening of plasmodium infection must be as efficient as possible. The main aim of our study was to assess our malaria testing strategy based on a single Elisa test compared with a two-step strategy implying immunofluorescence testing as confirmation test. The second goal was to describe characteristic of malaria Elisa positive donors. We conducted a prospective study: every malaria Elisa positive test was implemented by immunofluorescence testing and demographical data were recorded as usual by our medical software. We showed a significant risk of malaria ELISA positive tests among donor born in endemic area and we estimate the number of abusively 3-year rejected donors. However, based on our estimations, the two-step strategy is not relevant since the number of additionally collected blood products will be low.

[Haemovigilance and blood safety in overseas military]. / Hémovigilance et sécurité transfusionnelle en opération extérieure.

The French military blood institute (FMBI) is the only military blood supplier in France. FMBI operates independently and autonomously under the Ministry of Defense's supervision, and accordingly, to the French, European and NATO technical and safety guidelines. FMBI is in charge of the collection, preparation and distribution of blood products to supply transfusion support to armed forces, especially during overseas operations. In overseas military, a primary physician is responsible for haemovigilance in permanent relation with an expert in the FMBI to manage any adverse reaction. Additionally, traceability of delivered or collected blood products during overseas operation represents a priority, allowing an appropriate management of transfusion inquiries and assessment of practices aiming to improve and update procedures and training. Transfusion safety in overseas operation is based on regular and specific training of people concerned by blood supply chain in exceptional situation.

[Therapeutic plasmas available worldwide]. / Les plasmas thérapeutiques dans le monde.

Therapeutic plasma is a current product; French guidelines were reviewed in 2012. Connections between more or less closed countries are frequent, during relief disasters as well as in war settings. This is associated with the increasing use of plasma in the management of casualties. Additionally, The real possibility of lack of plasma supply in some countries provides a fundamental interest of the knowledge of foreign blood supply organizations. We present here the main divergences and mutual point between plasmas available worldwide. We present the main characteristics of each product.

[Evolution of US military transfusion support for resuscitation of trauma and hemorrhagic shock]. / Évolution de la réanimation transfusionnelle du blessé hémorragique grave au sein des forces militaires américaines.

Military conflicts create a dynamic medical environment in which the number of severe trauma cases is compressed in both time and space. In consequence, lessons are learned at a rapid pace. Because the military has an effective organizational structure at its disposal and the logistical capacity to rapidly disseminate new ideas, adoption of novel therapies and protective equipment occurs quickly. The recent conflicts in Iraq and Afghanistan are no exception: more than three dozen new clinical practice guidelines were implemented by the US Armed Forces, with attendant survival benefits, in response to observation and research by military physicians. Here we review the lessons learned by coalition medical personnel regarding resuscitation of severe trauma, integrating knowledge gained from massive transfusion, autopsies, and extensive review of medical records contained in the Joint Theater Trauma Registry. Changes in clinical care included the shift to resuscitation with 1:1:1 component therapy, use of fresh whole blood, and the application of both medical devices and pharmaceutical adjuncts to reduce bleeding. Future research will focus on emerging concepts regarding coagulopathy of trauma and evaluation of promising new blood products for far-forward resuscitation. New strategies aimed at reducing mortality on the battlefield will focus on resuscitation in the pre-hospital setting where hemorrhagic death continues to be a major challenge.

[Blood transfusion on battlefield. The Kabul hospital experience]. / Transfusion sanguine en opération extérieure. Expérience à l'hôpital médico-chirurgical de Kaboul.

OBJECTIVES: Blood transfusion is an aspect of medical care on the battlefield. French assets include: red blood cell units (RBCu), lyophilized plasma (PLYO), fresh whole blood (FWB) but neither fresh-frozen plasma (FFP) nor platelets. French transfusion strategy in military operations follows the evolution of knowledge and resources. We describe the characteristics of the transfusion at the military hospital in Kabul. PATIENTS AND METHODS: Retrospective study of records of patients transfused between October 2010 to December 2011 conducted in Kabul from transfusion register. Variables studied were: patient characteristics, biology at admission, type and amount of transfusion products, evolution. RESULTS: One hundred and twenty-six patients were transfused: 49 military (39%) which 22 French soldier (17%), most of time afghan (n=97; 77%), mean age at 24 years old (3-66). Two hundred and seventy-three RBCu from France were transfused and 350 unused were destroyed. Conditions leading to a transfusion were: 76 war wounds (60%), 21 trauma (17%) and 29 other (23%). In the first 24 hours, patients received in mean: two RBCu (0-12), one unit of FWB (0-18) and two PLYO (0-14). PLYO/RBCu ratio was 1/1.6. A massive transfusion (more than 10 RBCu) concerned 9% of patients. Twenty-seven percent of patients received FWB. We note 17 dead people (13.5%). CONCLUSION: The use of the FWB and PLYO in substitution of FFP and platelets can provide cares of high quality in a logistically constrained context while controlling costs.

The concept of damage control: extending the paradigm in the prehospital setting.

OBJECTIVE: The purpose of this review is to present the progressive extension of the concept of damage control resuscitation, focusing on the prehospital phase. ARTICLE TYPE: Review of the literature in Medline database over the past 10 years. DATA SOURCE: Medline database looking for articles published in English or in French between April 2002 and March 2013. Keywords used were: damage control resuscitation, trauma damage control, prehospital trauma, damage control surgery. Original articles were firstly selected. Editorials and reviews were secondly studied. DATA SYNTHESIS: The importance of early management of life-threatening injuries and rapid transport to trauma centers has been widely promulgated. Technical progress appears for external methods of hemostasis, with the development of handy tourniquets and hemostatic dressings, making the crucial control of external bleeding more simple, rapid and effective. Hypothermia is independently associated with increased risk of mortality, and appeared accessible to improvement of prehospital care. The impact of excessive fluid resuscitation appears negative. The interest of hypertonic saline is denied. The place of vasopressor such as norepinephrine in the early resuscitation is still under debate. The early use of tranexamic acid is promoted. Specific transfusion strategies are developed in the prehospital setting. CONCLUSION: It is critical that both civilian and military practitioners involved in trauma continue to share experiences and constructive feedback. And it is mandatory now to perform well-designed prospective clinical trials in order to advance the topic.

[Practice assessment in platelet transfusions]. / Évaluation des pratiques transfusionnelles plaquettaires.

PURPOSE OF THE STUDY: Platelet transfusion follows the national guidelines published in 2003 by the AFSSAPS, determining, for instance, indications, transfusion threshold and platelets dose. We wanted to assess how these guidelines are routinely used in our hospital, with a special focus on transfusion threshold and delivered dose. MATERIAL AND METHODS: We conducted a prospective study during 11 months on every platelet transfusion. Our establishment is a medium size structure, devoted to emergency and oncology, without bone marrow transplantation. During this period, 235 products were delivered to 105 patients. Half (52%) were delivered to oncological units, a third to emergency units and the remaining to medical and surgical units. RESULTS: The average dose was 4.3±0.8×10(11) platelets (2.0 to 7.6×10(11) platelets), corresponding to 0.45×10(11) platelets per 7kg. During prophylactic transfusions, the average platelet count was 9.4±5.5G/L ; during curative transfusions (43%), it was 39.0±47.8G/L and finally when platelets were infused during surgery (21%), the average platelet count was 57.8±61.4G/L. CONCLUSION: Globally, with regard to transfusion threshold, guidelines were followed in 71%, and 93% in oncological units. Transfusion efficacy, attested by post-transfusion platelet efficiency was above 20% in 59% of the cases. These data highlight a good respect of the transfusion thresholds in the usual platelets-consuming units, but raise the question of the dose, often under those proposed by the guidelines.

[Factsheets: support in the analysis of recipients' adverse reactions]. / Fiches techniques: aide à l'analyse des effets indésirables receveurs.

In order to help the analysis of adverse effects of transfusion, factsheets have been written by working groups of the French agency for the safety of health products ANSM. Each factsheet deals with a blood transfusion side effect and is composed of five parts, including pathophysiological mechanisms, diagnostic criteria, management recommendations, etiologic investigations and rules for filing the notification form to ANSM. Since 2006, 11 factsheets have been published on the French haemovigilance network website. The major characteristics of the two last sheets published "post-transfusion purpura" and "non erythrocyte incompatibility reaction" are presented, followed by the updated card for "allergy". These factsheets give relevant guidelines allowing better evaluation of recipients' adverse reactions, particularly their diagnosis, severity and accountability. They also could initiate studies among European and international haemovigilance networks.

[Blood transfusion in emergency settings: French military health service experience]. / La transfusion en situation d'exception, expérience du service de santé des armées.

Blood transfusion is required in a number of emergency settings and the French military health service (FMHS) has issued specific guidelines for the treatment of war casualties. These guidelines take into account European standards and laws, NATO standards, and also public sentiment regarding transfusion. These guidelines reflect a determination to control the process and to avoid the improvisation frequently associated with wartime transfusion. The evolution in warfare (terrorism and bombing more frequent than gunshot) and the wide use of body armor have deeply changed the clinical presentation of war injuries. These now involve the extremities in 80% of cases, with extensive tissue damage and heavy blood loss. The FMHS recommends that war casualties with hemorrhagic shock be brought quickly to a medical treatment facility (MTF) after first-line treatment applied through buddy aid or by medics. In the MTF, before an early Medevac, a damage control surgery will be performed, with resuscitation using freeze-dried plasma, red blood cells and fresh whole blood. The French military blood bank is responsible for blood product supply, training and medical advice regarding transfusion therapy during wartime, as well as hemovigilance. All transfusion therapy practices are periodically assessed but research on whole blood pathogen reduction is being conducted in order to reduce the residual infectious risk associated with this product.

[French European military haemovigilance guidelines]. / Déclinaisons militaires Françaises des directives Européennes en matière d'hémovigilance.

European military transfusion services follow operational guidelines established by their respective national health systems and conform with European Union directives and NATO standards as applicable to member countries. Certain features are common to all of these standards, especially the pre-selection of volunteer, almost exclusively unpaid donors. NATO requirements are very close to European guidelines, with the exception that NATO permits the use of blood products collected in emergency conditions in theater when circumstances allow no better option. Blood product traceability exists for every country but is not always centralized or computerized. Serious adverse event reporting relies on national haemovigilance networks. Military considerations become important mainly in overseas operations, where the overall policy is to implement the relevant national, European or NATO guidelines with adjustments made for unique wartime circumstances and the risk/benefit ratio for the individual patient needing a transfusion.