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™ efficacy

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ClearPlasma™ was tested in several animal models with massive bleeding

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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%. 

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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 :

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PlasFree is initiating a clinical trial to examine the safety and efficacy if ClearPlasma

 

ClearPlasma™ safety

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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.

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Description of disease being studied and problem being addressed

Acute upper gastrointestinal bleeding (UGIB) is frequent, with an estimated annual incidence of 60/100 000 in USA (iii). The incidence of UGIB is higher in men than in women and increases with age. It commonly presents with hematemesis and/or melena. The most common sources of bleeding are  gastric or duodenal ulcers, esophageal varices, erosive esophagitis/gastritis/duodenitis, and mass lesions.

Objectives

Examination of safety of 1-2 units of ClearPlasma in patients presenting with acute upper gastrointestinal bleeding

Primary

This is a non-inferiority study. The main outcome is safety; thromboembolic events (venous or arterial ) [ Time Frame:  2 weeks ]

And adverse reactions to plasma

Secondary

Efficacy. Total blood loss after plasma transfusion [ Time Frame: The first post plasma transfusion 48h ]

 

Evaluation of blood loss:

1 RBC’s blood units  transfused [ Time Frame:  30 days] 

2. Plasma units  transfused [ Time Frame:  30 day] 

3. Hemoglobin drop – compare to baseline [ Time Frame:  48h ]

4. Platelets  units transfused [ Time Frame:  30 days ]

5. Re-bleeding episodes [ Time Frame: 30 days ]

 

B. Length of hospital stay [ Time Frame: during 30 days of follow-up.  

C.  Mortality related to plasma transfusion  

Study Design

A randomized, double blind, -controlled trial to evaluate the safety and efficacy of plasminogen-depleted plasma filtered by ClearPlasma device in patients presenting with acute upper gastrointestinal bleeding.

Single center or multicenter

Multi / single center

Phase

I/II

Single center or multicenter

Multi / single center

Number and definition of arms

Two arms:

  1. Transfusion of up to two units of plasminogen depleted plasma (PDP). Each unit of plasma contains approximately 250 ml. If more plasma is required the patient will receive regular plasma

  2. Transfusion of regular plasma only 

Blinding

Double blind

Randomization if multiple arms

Randomized

Indication and patient population

Patients presenting with acute upper gastrointestinal bleeding

Sample size

80 (40 in each group)