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).

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.

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.

[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.

[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.