Development and Testing of Low-Volume Hyperoncotic, Hyperosmotic Spray-Dried Plasma for the Treatment of Trauma-Associated Coagulopathy

Shuja, Fahad; Finkelstein, Robert; Fukudome, Eugene Y.; Duggan, Michael; Kheirbek, Tareq; Hamwi, Kristopher B.; Fischer, Thomas; Fikry, Karim; DeMoya, Marc; Velmahos, George C.; Alam, Hasan B.

doi:10.1097/ta.0b013e31820e83be

Cited by 34 publications

(33 citation statements)

References 27 publications

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“…19,20 In a porcine trauma model, treatment with FLyP resulted in excellent early survival. 21 Multiple injuries and hemorrhagic shock cause an increase as great as 70% in prothrombin time, and both lyophilized plasma and FFP have been shown to be equally effective in correcting the coagulopathy. 17 Because some concerns arose about the ability of the process to perform viral inactivation in the pooled plasma, its use decreased during the 1960s and 1970s.…”

Section: Discussionmentioning

confidence: 99%

In Vitro Hemostatic Properties of French Lyophilized Plasma

Martinaud¹,

Civadier

Ausset³

et al. 2012

Anesthesiology

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Background: French lyophilized plasma (FLyP) is used routinely by the French Armed Forces in war settings. The authors compared concentrations of coagulation proteins and global in vitro hemostatic properties in FLyP and in the same plasma before lyophilization to assess the impact of lyophilization on coagulation properties. Methods: Twenty-four batches of plasma before and after lyophilization were tested for coagulation proteins. Thrombin generation time, thrombin antithrombin concentration, prothrombin fragment 1 ϩ 2, and thromboelastography were assessed. Finally, the efficiencies of FLyP and plasma before lyophilization were compared on a hemorrhagic shock hemodilution model and tested on TEG

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Section: Discussionmentioning

confidence: 99%

In Vitro Hemostatic Properties of French Lyophilized Plasma

Martinaud¹,

Civadier

Ausset³

et al. 2012

Anesthesiology

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“…[54][55][56][57] Finally, IV plasma may be effective for shock; however, it is difficult to deliver and store in prehospital, tactical settings, and lyophilized or freeze-dried plasma has not been fully studied. [58][59][60] In addition, plasma and other blood products are expensive and carry infection risks. 61 A smallvolume, simple, durable, portable drug that improves blood pressure and survival is needed to treat hemorrhagic shock in the tactical environment, and hydroxocobalamin may be a potential candidate based on our study results.…”

Section: Discussionmentioning

confidence: 99%

A Prospective, Randomized Trial of Intravenous Hydroxocobalamin Versus Whole Blood Transfusion Compared to No Treatment for Class III Hemorrhagic Shock Resuscitation in a Prehospital Swine Model

Bebarta

Garrett

Boudreau

et al. 2015

Academic Emergency Medicine

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Objectives: The objective was to compare systolic blood pressure (sBP) over time in swine that have had 30% of their blood volume removed (Class III shock) and treated with intravenous (IV) whole blood or IV hydroxocobalamin, compared to nontreated control animals.Methods: Thirty swine (45 to 55 kg) were anesthetized, intubated, and instrumented with continuous femoral and pulmonary artery pressure monitoring. Animals were hemorrhaged a total of 20 mL/kg over a 20-minute period. Five minutes after hemorrhage, animals were randomly assigned to receive 150 mg/ kg IV hydroxocobalamin solubilized in 180 mL of saline, 500 mL of whole blood, or no treatment. Animals were monitored for 60 minutes thereafter. A sample size of 10 animals per group was determined based on a power of 80% and an alpha of 0.05 to detect an effect size of at least a 0.25 difference (>1 standard deviation) in mean sBP between groups. sBP values were analyzed using repeated-measures analysis of variance (RANOVA). Secondary outcome data were analyzed using repeated-measures multivariate analysis of variance (RMANOVA).Results: There were no significant differences between hemodynamic parameters of IV hydroxocobalamin versus whole blood versus control group at baseline (MANOVA; Wilks' lambda; p = 0.868) or immediately posthemorrhage (mean sBP = 47 mm Hg vs. 41 mm Hg vs. 37 mm Hg; mean arterial pressure = 39 mm Hg vs. 28 mm Hg vs. 34 mm Hg; mean serum lactate = 1.2 mmol/L vs. 1.4 mmol/L vs. 1.4 mmol/L; MANOVA; Wilks' lambda; p = 0.348). The outcome RANOVA model detected a significant difference by time between groups (p < 0.001). Specifically, 10 minutes after treatment, treated animals showed a significant increase in mean sBP compared to nontreated animals (mean sBP = 76.3 mm Hg vs. 85.7 mm Hg vs. 51.1 mm Hg; p < 0.001). RMANOVA modeling of the secondary data detected a significant difference in mean arterial pressure, heart rate, and serum lactate (p < 0.001). Similar to sBP, 10 minutes after treatment, treated animals showed a significant increase in mean arterial pressure compared to nontreated animals (mean arterial pressure = 67.7 mm Hg vs. 61.4 mm Hg vs. 40.5 mm Hg). By 10 minutes, mean heart rate was significantly slower in treated animals compared to nontreated animals (mean heart rate = 97.3 beats/min vs. 95.2 beats/min vs. 129.5 beats/min; p < 0.05). Serum lactate, an early predictor of shock, continued to rise in the control group, whereas it did not in treated animals. Thirty minutes after treatment, serum lactate values of treated animals were significantly lower compared to nontreated animals (p < 0.05). This trend continued throughout the 60-minute observation period such that 60-minute values for lactate were 1.4 mmol/L versus 1.1 mmol/L versus 3.8 mmol/L. IV hydroxocobalamin produced a statistically significant increase in systemic vascular resistance compared to control, but not whole blood, with a concomitant decrease in cardiac output.

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“…Research into improving the availability and efficacy of plasma products for resuscitation has led to the development of single-donor freeze-dried plasma, which can be stored at room temperature close to patient care, and to resuscitation using plasma-derived coagulation factor concentrates [42]. �reeze-dried human plasma from donor pools was used in resuscitation in World War II but discredited because of high rates of associated hepatitis.…”

Section: Resistance To Damage Control Resuscitationmentioning

confidence: 99%

“…�reeze-dried human plasma from donor pools was used in resuscitation in World War II but discredited because of high rates of associated hepatitis. �oday, freeze-dried 600 ml units of apheresis-derived, pedigreed and quarantined single donor plasma are being prepared for clinical testing [42]. �he combination of light weight, room-temperature storage and the possibility of reconstitution in less than full fluid volume to make concentrated plasma has made the material attractive to military planners.…”

Section: Resistance To Damage Control Resuscitationmentioning

confidence: 99%

“…�he combination of light weight, room-temperature storage and the possibility of reconstitution in less than full fluid volume to make concentrated plasma has made the material attractive to military planners. However, the presence of all of the plasma proteins in the lyophilized material means that the ability to concentrate the coagulation factors will be limited by the colloid osmotic activity of albumin and that all of the allergic risks of conventional plasma products will occur with this product [42].…”

Section: Resistance To Damage Control Resuscitationmentioning

confidence: 99%

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