A Randomized Controlled Trial using iTClamp, Direct Pressure, and Balloon Catheter Tamponade to Control Neck Hemorrhage in a Perfused Human Cadaver Model.

BACKGROUND: Penetrating neck wounds are common in the civilian and military realms. Whether high or low velocity, they carry a substantial morbidity and mortality rate. OBJECTIVES: We endeavored to ascertain whether the iTClamp is equivalent to direct manual pressure (DMP) and Foley catheter balloon tamponade (BCT). METHODS: Using a perfused cadaver, a 4.5-cm wound was made in Zone 2 of the neck with a 1-cm carotid arteriotomy. Each of the hemorrhage control modalities was randomized and then applied to the wound separately. Time to apply the device and fluid loss with and without neck motion was recorded. RESULTS: There was no significant difference between the fluid loss/no movement (p > 0.450) and fluid loss/movement (p > 0.215) between BCT and iTClamp. There was significantly more fluid lost with DMP than iTClamp with no movement (p > 0.000) and movement (p > 0.000). The iTClamp was also significantly faster to apply than the Foley (p > 0.000). CONCLUSIONS: The iTClamp and BCT were associated with significantly less fluid loss than DMP in a perfused cadaver model. The iTClamp required significantly less time to apply than the BCT. Both the iTClamp and the BCT were more effective than simple DMP. The iTClamp offers an additional option for managing hard-to-control bleeding in the neck.

Evaluation of the iTClamp 50 in a human cadaver model of severe compressible bleeding.

BACKGROUND: Uncontrolled hemorrhage is a significant cause of preventable death. The iTClamp 50 is a temporary wound closure device designed to control bleeding within seconds of an injury. This study evaluates the ability of the iTClamp to control compressible bleeding in a human cadaver model. METHODS: Sterile water was pumped through the major arteries to mimic blood flow. Full-thickness, elliptical segments of skin were excised; arteriotomies or complete transections were performed on the major arteries in the thigh (distal femoral), groin (common femoral), neck (carotid), and arm (brachial). Scalp wounds were created by making a 4.4-cm linear incision to the level of the bone. Fluid losses from the wounds were compared with and without the iTClamp applied and with and without movement of the cadaver. Angiographic images of pressure-injected contrast were obtained of the neck and groin wounds. Hematoma volumes and needle penetration depth into the skin were measured. RESULTS: In all wounds tested, application of the iTClamp significantly reduced fluid loss in all wounds studied (p < 0.05), and movement of the cadaver did not affect the function of the iTClamp. For example, in one groin wound, the average fluid loss during 1 minute was reduced from 728.4 ± 79.3 mL to 5.6 ± 3.4 mL. Distal flow was maintained during application of the iTClamp, as illustrated in angiographic images obtained of the iTClamp applied to the neck and groin wounds. The average needle penetration depth into the skin was 4.21 ± 0.02 mm; furthermore, the iTClamp did not cause any visible skin damage or skin tearing. CONCLUSION: The iTClamp is effective at controlling fluid loss from open wounds within multiple compressible areas. The iTClamp does not occlude distal flow, and aside from small needle punctures, there was no other visible skin damage or skin tearing.

The immunomodulatory effects of hypertonic saline resuscitation in patients sustaining traumatic hemorrhagic shock: a randomized, controlled, double-blinded trial.

OBJECTIVE: To investigate the potential immunologic and anti-inflammatory effects of hypertonic saline plus dextran (HSD) in hemorrhagic trauma patients. BACKGROUND: Unbalanced inflammation triggered by shock has been linked to multiorgan dysfunction (MOD) and death. In animal and cellular models, HSD alters the inflammatory response to shock, attenuating MOD and improving outcome. It remains untested whether HSD has similar effects in humans. METHODS: A single 250-mL dose of either HSD (7.5% NaCl, 6% dextran-70) or placebo (0.9% NaCl) was administered to adult blunt trauma patients in hemorrhagic shock. The primary outcome was to measure changes in immune/inflammatory markers, including neutrophil activation, monocyte subset redistribution, cytokine production, and neuroendocrine changes. Patient demographics, fluid requirements, organ dysfunction, infection, and death were recorded. RESULTS: A total of 27 patients were enrolled (13 HSD) with no significant differences in clinical measurements. Hyperosmolarity was modest and transient, whereas the immunologic/anti-inflammatory effects persisted for 24 hours. HSD blunted neutrophil activation by abolishing shock-induced CD11b up-regulation and causing CD62L shedding. HSD altered the shock-induced monocyte redistribution pattern by reducing the drop in "classic" CD14 and the expansion of the "pro-inflammatory" CD14CD16 subsets. In parallel, HSD significantly reduced pro-inflammatory tumor necrosis factor (TNF)-alpha production while increasing anti-inflammatory IL-1ra and IL-10. HSD prevented shock-induced norepinephrine surge with no effect on adrenal steroids. CONCLUSIONS: This first human trial evaluating the immunologic/anti-inflammatory effects of hypertonic resuscitation in trauma patients demonstrates that HSD promotes a more balanced inflammatory response to hemorrhagic shock, raising the possibility that similar to experimental models, HSD might also attenuate post-trauma MOD.