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LEUKAPHERESIS RISKS


Just like any medical procedure, risks are inevitably involved. The risks associated with leukapheresis are associated with the decrease in WBC count, interaction with anticoagulation solutions, and the actual venipuncture site for withdrawal and return of blood. Detailed below are the risks involved with the leukapheresis procedure for those otherwise healthy participants (i.e. patients donating for research purposes as opposed to patients receiving therapeutic leukapheresis for treatment of hyperleukocytosis).

Hypocalcemia

Hypocalcemia is a decrease in calcium levels. Hypocalcemia is a response to citrate toxicity, which can result with large volume leukapheresis treatments. Symptoms of hypocalcemia include numbness and tingling, especially in the hands, feet, and around the mouth. Hypocalcemia can also cause painful muscle spasms that can be alleviated with calcium-rich foods and supplements. If symptoms persist during the procedure, the following protocols are advised: slowing the procedure, decreasing the amount of anticoagulation, and administering oral or intravenous calcium supplementation.

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Vasovagal Response

Few subjects experience episodes of vasovagal responses such as lightheadedness or fainting. These occurrences are induced by extracorporeal blood flow and discomfort and/or fear of venipunctures. Major vasovagal episodes have been reported from patients receiving therapeutic leukapheresis in research for treatment of polymyositis and dermatomyositis, diseases of the muscle tissue.

Venous Access/Need for Catheter

For otherwise healthy patients utilizing leukapheresis for donation to research, peripheral access may be used for the procedure. Venous access is dependent on the individual integrity of the structural components of the antecubital veins. In some cases, for reasons including but not limited to difficulty in locating strong venous support or poor blood flow, catheter placement may be necessary. Cannula and catheter-related complications are not unique to the leukapheresis procedure.

Blood Loss

Varying, minor degrees of RBC or platelet loss have been reported. Devices separate and return blood according to different manufacturer settings that may have an influence on accounted hemoglobin or hematocrit levels. Significant blood loss, however, has not been reported. Patients with a history of anemia or thrombocytopenia should proceed leukapheresis treatments with caution.

Discomfort at Venipuncture Site

Discomfort, bruising, bleeding, or swelling at the venipuncture site may occur. These minor interactions may occur with any venipuncture procedure and is usually dependent on venous structural integrity. Routine procedures are in place at each facility to help minimize the occurrence of these discomforts and, in some cases, an alternate venipuncture site may be utilized.

Infection

Infection, although rare, can occur at the venipuncture site due to cannula or catheter placement. Infection is minimized with proper sterilization standards and has been significantly reduced with disposable collection and storage equipment.

See LEUKAPHERESIS PRODUCTS for more information on studies involving antifungal activity.

To significantly reduce the occurrence of these side effects, routine protocols are set in place at most facilities to prepare for leukapheresis treatments [PPA IRB Protocol]. These standing orders from the medical director include but are not limited to:

• Eat foods containing calcium such as low fat milk, cheese, yogurt, tofu, spinach, kale, other dark green vegetables, almonds, and sunflowers
• Eat foods low in saturated fats in the 48 hours prior to leukapheresis treatment
• Drink plenty of non-caffeinated fluids such as water the day of donation
• Get plenty of rest
• Eat a meal at least 2 hours prior to leukapheresis treatment
• If prone to low calcium reactions, take 2 Tums™ or equivalent calcium supplements at the time leukapheresis treatment


"Physician’s Plasma Alliance (PPA) can collect bulk quantities of plasma, serum, blood or other human biological materials ranging from a single unit to thousands of liters. Whether you need healthy or disease state donor material: PPA has access to the patients your research requires. "
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