AriClot Powder 

The AriClot powder produced by Healda, utilizing modern methods and safe biopolymers, will quickly prevent blood loss. This biodegradable and biocompatible compound is completely absorbed by the body's enzymes within 5 to 72 hours after use. Healda hemostatic powder rapidly stops various types of bleeding (capillary, venous, and arterial), reducing the need for blood transfusions. It facilitates surgery and trauma management, improving the patient's condition, increasing survival rates, and enhancing medical services.

Mechanism of action:
This biocompatible product is designed to control bleeding (capillary, venous, and arterial) and its role in stopping bleeding and rapid blood coagulation can be explained through the following mechanisms:
1- Concentration of coagulation factors, platelets, red blood cells, thrombin, etc., to initiate the clotting process.
2- Creating a soft but strong biopolymer matrix to mechanically block the exterior of damaged vessels.

The biodegradable and biocompatible Healda​​​​​​​ powder is free from any allergies, skin irritation, and cellular toxicity. Its efficacy has been demonstrated in clinical studies in accordance with ISO10993-5, ISO10993-10, ISO10993-11 standards. According to tests conducted by the Hemophilia and Thalassemia Research Center (Shahid Dastgheib Hospital), the effectiveness and speed of hemostasis of this compound have been recognized as superior compared to current global samples.

Features:
- Polysaccharide-based
- Biocompatible and biodegradable
- Free of animal or human coagulating agents (eliminates the risk of transmissible zoonotic diseases)
- Does not cause tissue adhesion (Adhesion formation) or inflammatory responses
- Degraded and absorbed by the body's enzymes in a short period (5-72 hours)
- Easy to use (no need for special mixing conditions or specific storage conditions)
- Long shelf life of up to 3 years
- Sterilized with radiation

Clinical particulars
Therapeutic indications
The primary purpose of the product is to control oozing bleeding. However, it can also be utilized as adjunctive treatment in hemostasis and local bleeding control in various types of wounds such as cuts, tears, burns, and other injuries caused by accidents. Additionally, it is suitable for use in different types of minor and major surgeries, as well as laparoscopic or robotic procedures (excluding brain, nerve, and eye surgeries), situations like wars, accidents, natural disasters, and more. This product can be effectively used in conjunction with other treatment methods.
Posology and Method of administration
The powder does not require dissolution or mixing and can be applied directly to wounds or bleeding areas. An applicator contains a predefined dosage of powder, and depending on the wound area, multiple packs can be used in one procedure. There is currently no toxicity report for this material, but it is recommended that the total dosage for a single procedure does not exceed 50 grams (based on recommendations of other similar products). It is a powder that is fully absorbed by human cells and can be used by both adults and children.
Method of administration:
1-      Dry the bleeding area with gas or suction.
2-      Spray the appropriate amount of AriClot ™ on the wound surface.
3-      For oozing bleeding, this operation will be sufficient. To increase the efficiency of hemostasis, a moist gauze can be used at the dressing site. For severe bleeding, place a dry gauze on the powder spray site and hold it for 2 minutes with hand pressure. Make sure the bleeding stops before removing the gauze. Continue to squeeze if bleeding continues. After making sure that the bleeding has controlled, pour some normal saline on the gauze to make sure that the gel is formed. Then remove the gauze, in special cases (for diabetic patients) it is better to remove the remaining powder by washing.
For open surgery:
Before use, make sure that the packaging and the applicator are intact. If any is damaged, do not use it. Remove the cap of the applicator with a bending and twisting motion. For maximum benefit, the following technique is recommended:
1- Clean the excess blood from the bleeding tissue. It is very important to remove excess blood, apply the coagulant powder directly to the site of active bleeding.
2- Place the tip of the applicator as close as possible to the bleeding source. Immediately spray some of the powder on the bleeding site to cover the wound completely. For deep wounds, it is necessary to use an epilator with a longer nozzle. To minimize tip blockage, pressure should be applied to deliver the sprayed powder to the wound.

Contraindications
AriClotTM powder must not be used in the following cases:
1. Do not use in Neurosurgery and ophthalmic surgeries.
2. Avoid injection into veins and arteries.
3. Consult with a physician if there is a history of sensitivity to sugar compounds.
4. In case of infection or in contaminated areas of the body, the blood clotting powder should be used with caution.
5. It is advisable not to use the powder in cases where there is a lack of local blood flow due to tight tourniquet closure or vascular occlusion under pressure, as this may lead to the powder entering the veins, causing thrombosis and congestion due to the absence of positive blood outflow. It is best to refrain from using the powder until blood flow is restored to the limb.

Special warnings and precautions for use
Blood coagulant powder is supplied as a sterile product and cannot be re-sterilized. Opened applicators should be discarded.
AriClotTM powder should be used with particular caution in the following cases:
1-      Caution should be exercised when using this product in infants under 24 months of age. While there is limited research specifically focused on this age group, evidence from similar products suggests a potential decrease in the activity of the amylase enzyme in this population. Avoid more than 30 gram (6 to 10 packages of 5 or 3’ gram doses) in one procedure.
2-      hypersensitivity or severe food allergy or known case of amylase deficiency
3-      don’t combine multiple coagulant agents on one site
4-      The breakdown of this product into glucose may affect blood glucose levels in diabetic patients. Caution should be exercised when administering high amounts of powder (more than 30 grams) to diabetic patients, and blood glucose levels should be monitored for the next 48 hours. This recommendation is based on similar product cautions.
5-      Since these hemostatic agents work through barrier method by superabsorbent and swelling mechanisms, the application near a nerve root or brain can cause pressure effect on the nerve.
Interaction with other medicinal products and other forms of interaction
AriClotTM is a pure vegetable starch with excellent biocompatibility and biodegradability properties. Unlike other hemostatic agents that may take up to 3-4 weeks to absorb, this product breaks down quickly to simple sugar and has a fast absorption time.  Until now, no interaction was reported for AriClotTM but based on the report of other hemostatic agents these coagulant agents should not be used in patient with hypercoagulative stat.
Fertility, pregnancy and lactation
AriClotTM have not been clinically evaluated in children and pregnant women. Because there have been reports of decreased amylase activity in newborns up to 10 months, absorption rates in this population may be longer than 48 hours
Effects on ability to drive and use machines
No contraindication.
Overdose
AriClotTM can be digest in the GI system and theoretically there is no risk of poisoning. If it used accidently used by oral route may cause temporary bowel obstruction. If any abdominal symptom develops refer to emergency department. No need for specific antidot and the plug gradually dissolved.
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Comparison with similar products:
Flowability and spreadability
- The spreadability of the powder is a factor that affects its hemostatic efficiency. This index is determined based on the angle of repose. The smaller the angle of repose, the better the spreadability and quality of the product.
- The results of comparing Healda powder with three of the world's leading hemostasis samples show a lower number and consequently better coverage.

Water Absorption Rate

- The primary mechanism of hemostatic powders is the speed and amount of blood water absorption, ultimately concentrating the clotting agents. Healda hemostasis powder absorbs a large volume of blood water in a very short time. In this regard, Healda hemostasis performs significantly better compared to similar foreign products.

Biodegradability
- A desirable characteristic of a biocompatible compound is its complete decomposition within an appropriate timeframe. Faster decomposition of the hemostasis compound can reduce undesirable effects such as inflammatory responses. The Healda sample in the decomposition and biodegradability test is fully absorbed from a few hours to ultimately one day. This duration is significantly less compared to similar samples.

Hemolysis
- According to the blood compatibility standard (ISO 10993-4), the hemolysis threshold for the quality rejection of hemostasis products is declared to be 5%. Healda hemostasis powder, due to the presence of biocompatible compounds, does not have a destructive effect on red blood cells and has also shown better performance in this regard compared to similar foreign samples.

Blood Coagulation Test
- The coagulation ability of Healda hemostasis was indicative of its superior quality in comparison with similar samples in cases of severe and very severe bleeding in New Zealand rabbits.
- Healda hemostasis caused the cessation of fatal bleeding in 100% of cases, while the best similar foreign powder only managed to stop bleeding in 40% of cases. Healda showed superior efficiency in a shorter amount of time.

Histopathological Evaluation
- To evaluate and compare histopathologically, the ISO10993-6 guideline is used. After using AriClot, no discoloration, edema, inflammation, hematoma, encapsulation, fibrosis, or necrosis was observed. After conducting histopathological tests, AriClot was superior to foreign samples. According to the ISO10993-6 guideline, Healda hemostasis is completely safe, showing remarkable ability in preventing both severe and mild bleeding without causing any cellular or tissue complications.