Coagulation Disorder Program Overview

How the Program Works | Facts You Need to Know | Facts About Coagulation Disorders | Facts About Heparin

How the Program Works

Coagulation disorders occur when one of the many substances involved in the blood clotting process fails to work properly and results in a blood clot. Blood clotting can lead to serious complications and even death during and after pregnancy. Accurate diagnosis and careful administration of anticoagulation therapy is essential to manage these complications and optimize patient health while avoiding side effects.

Under physician direction, Heparin, an injectable anticoagulant, is administered at varying rates to achieve a patient-specific predetermined laboratory goal. Alere's Coagulation Disorder Management Program provides comprehensive obstetrical nursing care complemented by a full-time pharmacy staff experienced in obstetrics. Clinicians work with patients during at-home visits and regular telephonic interactions to help them improve self-care skills with the primary goal of preventing prenatal complications.

When prescribed, Alere's services for our Coagulation Disorder Management Program include:

• An initial home visit that includes home assessment and appropriate patient education
• Nursing support as required
• Provision of equipment and medical supplies
• Consultations with pharmacists experienced in the management of anticoagulants
• Detailed clinical reports

Alere's coagulation program provides the following:

• Experience/expertise in obstetrical homecare
• Comprehensive patient education
• 24-hour availability of high-risk obstetrical nurses
• Experienced clinical pharmacist consultations
• Patient-specific dosing guidelines
• Microinfusion pump technology providing continuous infusions and patient
• specific dosings
• Improved patient compliance
• Detailed clinical reports

Alere's program is designed to meet the following goals:

• Reduce hospitalizations after birth
• Reduce costs from hospitalizations
• Result in pregnancy outcomes comparable to hospital management

Facts You Need to Know

More than one-third of all pregnant women develop complications costing $1 billion annually for 2 million hospital days. Women comprise 63 percent of the workforce, with 80 percent of them of childbearing age. Nine out of 10 women in the workforce will conceive while employed. Twelve percent of those pregnancies will end prematurely.

Between 1992 and 2002, the number of preterm infants in the United States increased by 13 percent. Given that most premature infants must be hospitalized in neonatal intensive care units (NICUs), which cost an average of $2,000 a day, premature infants can cost as little as $5,000 and as much as $1 million depending on how early they are born and if they have serious medical problems.

Facts about Coagulation Disorders

Blood clots occur in approximately one out of 2,000 to three out of 1,000 pregnancies each year, which translates to .05 percent to .3 percent. Physicians typically prescribe anticoagulant medications for patients at risk for developing blood clots or who already have a blood-clotting disorder.

During pregnancy, there is an increase in the substances that cause blood to clot and a decrease in the substances that keep it from clotting. This altered balance in the clotting system causes pregnancy itself to be a risk factor for blood clotting. In addition to pregnancy, there are multiple other risk factors that include the following conditions:

• Obesity
• Maternal age greater than 35 years
• Prolonged bed rest or immobilization
• Surgery, including cesarean deliveries
• History of a previous blood clot

Symptoms of a blood clot (deep vein thrombosis-DVT) include:

• Pain and tenderness of the leg or other extremities
• Swelling and/or warmth of the leg or other extremities
• Local cyanosis (blue or purple discoloration of the skin)
• Fever

Possible adverse pregnancy outcomes in patients with coagulation disorders include but are not limited to:

• Maternal death
• Stillbirth
• Intrauterine growth restriction
• Severe preeclampsia
• Intrauterine fetal demise

Facts About Heparin

Heparin has proven to be effective at preventing and treating blood clots during pregnancy. Unlike most oral anticoagulants, the drug does not cross the placental barrier and expose the fetus to serious health risks and birth defects. Heparin does not remain in the body for long, which means dosing can be individually adjusted instantly and anticoagulation can be halted quickly for an emergency or a planned delivery.

Heparin is administered either via self-injection, continuous intravenous infusion or a subcutaneous infusion, which involves the placement of a tiny needle under the skin, through which the drug is administered via a small pump into the fatty tissue. The needle is replaced every five days. Decisions about when to administer heparin therapy during gestation and how long the treatment is used should be tailored to a patient's individual needs. A physician may begin this therapy as early as six weeks and continue up to 12 weeks after delivery.

Bleeding is the primary side effect and is often associated with high dosages that can be easily adjusted. A loss of bone density (osteoporosis) may also occur. Therefore, laboratory assessments and careful dosage management are required when this drug is used.

Clinical benefits from continuous subcutaneous or intravenous heparin infusions include individualized dosing, comfort and patient compliance. Intermittent injections of heparin may be painful and can lead to severe bruising or bleeding at the injection sites. Due to the short duration of action in the body, a patient who is noncompliant with the drug regimen may place herself at serious risk for a blood clot.

On the other hand, continuous administration of Heparin using a subcutaneous pump provides a continuous level of prescribed anticoagulation until the pump is replaced and allows for dosage adjustments according to each patient's need. In addition, patients infusing subcutaneously use a catheter to enhance comfort and reduce the number of skin punctures, which may lead to improved patient compliance.