PB1042 - Advancing Haemostasis: Evaluating the Efficacy of a Novel Superhydrophobic Nanofiber

Background:

Background: Bleeding trauma claims 2 million lives globally every year. Early intervention through more effective haemostatic devices can avert >25% of post-traumatic haemorrhagic deaths, but existing haemostatic devices adhere to wounds and cause dangerous secondary bleeding upon removal. We developed a superhydrophobic nanofiber (SNF) coating for haemostatic devices to induce clotting, reduce blood loss, and prevent secondary bleeding.

Aims: To evaluate SNF’s haemostatic safety and efficacy.

Methods: Calibrated automated thrombography (CAT) assays were performed to assess the coagulation potential of SNF (0-50mg/ml). SNF’s haemostatic efficacy was evaluated using a rat femoral arterial injury model. Mechanical testing was employed to quantify the ease of detachment from whole blood clots. Skin toxicity of SNF was assessed in primary keratinocytes.

Results: The addition of SNF to human plasma resulted in effective and concentration-dependent initiation of thrombin generation (TG) in platelet-rich (PRP) and platelet-poor plasma (PPP) with peak heights of 110±41nM and 344±82nM, respectively, at 50mg/ml SNF. When corn trypsin inhibitor (CTI) was added with SNF, TG was significantly reduced (by 82% and 88% compared to the absence of CTI for PRP and PPP, respectively), suggesting that SNF initiated TG through activation of factor (F)XII. Bleeding time for SNF-coated gauzes was 2min less than commercially available devices and 4min faster than uncoated gauzes in our rat model and blood loss was significantly reduced by >47% vs commercial devices. Furthermore, the peeling force needed to detach SNF-coated gauzes was 240mN, 5.25-fold lower than the uncoated control. Lastly, cell toxicity showed SNF does not cause necrosis, apoptosis, genotoxicity, or reduce cell viability at up to 200µg/ml.

Conclusion(s): SNF exhibits promising haemostatic efficacy, likely via FXII activation; SNF reduced blood loss by avoiding gauze soaking, leading to easy detachment, which may prevent secondary bleeding without toxic effects. Further testing is required to determine clinical efficacy and safety.