Inotech's Heparin Adsorbent is intended for the in vitro removal of heparin from the plasma of patients on heparin therapy or from plasma transported in heparin based anticoagulation tubes, prior to coagulation testing. Each tube will remove at least 2 Units of heparin per ml of plasma, returning APTT and TT values to baseline.

Product No.	Quantity
HA-1	10 tubes/pack	10% discount on order of 10 or more packs

                            

Packaging

Inotech's Heparin Adsorbent is supplied in polystyrene test tubes (10 per pack) sealed in a foil lined pouch.

Materials/Reagents

Each tube contains 70mg of Heparin Adsorbent. Each 1gm of heparin adsorbent contains 20mg of ECTEOLA-cellulose equilibrated in veronal buffer.

Shelf-Life

Tubes sealed in the foil lined pouch, maintained at room temperature (RT), have a shelf-life of 18 months beyond the date of manufacture. Once removed from the foil pouch, the exposed tubes have a shelf-life of 45 days when stored at RT in a high humidity sealed container (e.g. plastic box or zip-lock bag with a small aliquot of water or moistened paper towel added); or up to 35 days in a refrigerator, again in a sealed container. Water condensation on the inside walls of the tubes will not interfere with product performance.

Quality Control

Each lot is tested for the adsorption of heparin from human plasma by the manufacturer's laboratory and independently by a university hospital.

Explanation Of How Heparin Adsorbent Works

Heparin is a sulfated polysaccharide which is strongly acidic and negatively charged1. Because of heparin's exceptional anticoagulant activity, it has been used widely in both treatment and prevention of thrombosis. The major anticoagulant effect of heparin is its ability to bind with antithrombin III, a naturally occurring inhibitor of thrombin and other activated clotting factors2. The interaction of heparin, antithrombin III, and the clotting factors will lead to a state of anticoagulation via interference with the coagulation sequence3.

Therapeutic doses of heparin are administered to prevent progression of thrombosis, with care taken not provoke bleeding. Heparin therapy is effective in thrombotic diseases such as thromboembolism, arterial thrombosis, pulmonary embolism, coronary thrombosis, and myocardial infarction. It is also administered to patients with acute or disseminated intravascular coagulation in order to slow factor consumption and permit restoration of normal hemostasis3. Under these conditions, the recommended therapeutic dose for the drug will result in an average prolongation of the APTT (Activated Partial Thromboplastin Time) from 1.5 to 2.5 times the normal value.

Heparin is also used in high doses as a prophylactic during extracorporeal (outside the body) circulation, e.g., in cardiopulmonary bypass surgery, renal dialysis, and during use of indwelling catheters. Doses of heparin under these conditions result in a markedly prolonged APTT or prevent clot formation totally.

Inotech's Heparin Adsorbent, added to heparinized plasma, follows the principles of anion exchange. The ECTEOLA-cellulose component, a moderately basic anion exchange resin, binds the negatively charged heparin4. The heparin-cellulose complex is removed from the plasma by centrifugation, allowing coagulation tests to be performed without heparin interference.

The use of Inotech's Heparin Adsorbent allows the laboratory and physician to determine base line (pre-heparin treatment) values for the APTT and TT (Thrombin Time).

Performance Characteristics

Studies have shown that Inotech's Heparin Adsorbent will effectively remove at least 2 units of heparin per ml of plasma.

A comparison between untreated plasma samples and plasma samples with heparin added in vitro, which were then processed with Heparin Adsorbent, showed the APTT and TT values of the heparin containing plasma to return to the non-heparin plasma baseline values.

Assays for factors II, V, VII, VII, IX, X, XI, and XII were performed on 48 different plasma samples to which heparin was added in vitro and then processed with Heparin Adsorbent. Results showed no significant activity loss for the factors tested. Plasma samples obtained for the factor determinations were from normal subjects.

References
1.   Penner, J.; Kelly, P.: American Dade: Anticoagulants: Heparin and Coumadin; p.55-76.
2.   Rosenburg, R.D.: Actions and Interactions of Antithrombin and Heparin; N.Engl.J.Med. 292:146-151 (1975).
3.   Hudson, P.: American Dade: The Activated Partial Thromboplastin Time Test: A Laboratory Procedure for Factor Deficiency Screening and Heparin Monitoring (1983).
4.   Thompson, A.R.; Counts, R.B.: Removal of Heparin and Protamine from Plasma; J. Lab. Clin. Med. 88:6 922-929 (1976).