INFORMATION FOR PHYSICIANS
50% Less Bleeding
Pre-clinical trials indicate that plasminogen-depleted plasma obtained by using the PlasFree ClaerPlasma filtration device reduces the amount of bleeding by more than 50%.
ClearPlasma™ was tested in several animal models with massive bleeding
1. Tail Bleeding assay is widely used as an in vivo assessment of haemostatic action in rodents (1), the company has preformed several experiments utilizing this model and has demonstrated that ClearPlasma™ reduces the amount of bleeding in more than 50%.
ClearPlasma™ was Reduces the amount of bleeding in more than 50%. The blood cell pellet from the bleeding test was centrifuged and the supernatant was aspirated. Pellet size was then measured using a ruler. A. Pellet size results for each mouse; B. Statistical analysis of pellet size measurement. Statistics was calculated using One-way ANOVA followed by posthoc LSD/SCHELF( p<0.05 considered significant). (N=20 for each group) .
2. liver lacerations model- this model mimics trauma sustained to the liver. These trauma events can occur through either a blunt force such as a car accident, or a penetrating foreign object such as a knife. The company exmined ClearPlasma™ using this model in pigs. The Company demonstrated that plasma transfusion using ClearPlasma™ reduces the amount of bleeding in more than 50%, improves the hemodynamic parameters and benefits the animal condition.
Clinical Study :
PlasFree is initiating a clinical trial to examine the safety of ClearPlasma please find more information in the link: (https://clinicaltrials.gov/ct2/show/NCT04174989?cond=clearplasma&draw=2&rank=1)
The company examined the safety of the device and the improved plasma in several aspects:
Its effect on thromboembolic events, Pyrogenicity or Haemolysis of red blood cells. The company demonstrated that ClearPlasma did not increase the levels of thromboembolic events, fever or Haemolysis.