Magnesium Effects in Apheresis

NCT00040235 | Completed Phase 3

• 2 other identifiers: 02023402-CC-0234
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine whether magnesium replacement during apheresis can decrease side effects that donors commonly experience. Apheresis is a method of collecting large numbers of certain blood cells, such as white cells, stem cells, or platelets. In this procedure, whole blood is collected through a needle in an arm vein, similar to donating blood. The blood is separated into its components by centrifugation (spinning), the required cells are extracted, and the rest of the blood is returned to the body, either through the same needle or through another needle in the other arm. When healthy people donate cells by apheresis, a blood thinner called citrate is added to prevent the blood from clotting in the apheresis machine. Citrate works by reducing calcium in the blood. When the blood is returned to the donor, citrate from the machine is also returned, lowering the donor's calcium levels. As a result, donors often feel tingling around the mouth, hands, and feet. Some of these symptoms can be prevented by giving calcium intravenously (through a vein) during the procedure. Even with the added calcium, however, some donors still have symptoms. Magnesium levels are also lowered by citrate, but it is not known if this causes symptoms. This study will examine whether the decrease in magnesium levels also contributes to the side effects of apheresis and whether magnesium replacement can reduce these symptoms. Healthy apheresis donors 18 years of age or older who are enrolled in NIH protocols may participate in this study. Donors will undergo the apheresis procedures required by the NIH protocol they are enrolled in. Throughout the procedure, they will receive an intravenous infusion of a salt solution that may or may not contain magnesium. Blood samples of 5 milliliters (1 teaspoon) each will be taken from the apheresis machine at the beginning and end of the procedure and at 30- to 60-minute intervals during the procedure. No more than 50 ml (3 tablespoons) will be taken during any single apheresis. The last sample will be drawn 60 minutes after completion of the apheresis. In addition, donors will:

• Provide a urine sample at the beginning and end of each apheresis procedure.
• Donate an additional urine sample and an additional 5 ml blood sample the morning after apheresis
• Describe any symptoms experienced during apheresis to the apheresis nurse

Conditions

Healthy

Keywords

Leukapheresis; Hypomagnesemia; Plateletpheresis; Hypocalcemia; Citrate; Healthy Volunteer; HV; Normal Control

Interventions

magnesium PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy allogeneic subjects enrolled on NIH LVL protocols, with approval of the PI:
• NHLBI protocols-99-H-0046, 99-H-0050, 99-H-0064, 98-H-0122, 98-H-0006, 97-H-0202, 97-H-0196, 98-H-0154, 01-H-0162, 01-H-0010, 02-H-0111;
• NIAID protocols -98-I-0104, 01-I-0013;
• DTM protocols-00-CC-0165;
• NCI protocols-00-C-0119, 00-C-0201, 00-C-0206
• Weight greater than or equal to 40 kg
• Bilateral peripheral venous access
• Minimum LVL volume of 12 liters processed (per subject's primary protocol)
• Hematocrit greater than or equal to 35 percent
• Normal serum electrolyte, calcium and magnesium values
• Normal hepatic and kidney function tests
• Able to give informed consent
• Age greater than 18 years.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Mavroudis D, Read E, Cottler-Fox M, Couriel D, Molldrem J, Carter C, Yu M, Dunbar C, Barrett J. CD34+ cell dose predicts survival, posttransplant morbidity, and rate of hematologic recovery after allogeneic marrow transplants for hematologic malignancies. Blood. 1996 Oct 15;88(8):3223-9.

  PMID: 8874224 BACKGROUND

• Hester JP, McCullough J, Mishler JM, Szymanski IO. Dosage regimens for citrate anticoagulants. J Clin Apher. 1983;1(3):149-57. doi: 10.1002/jca.2920010306. No abstract available.

  PMID: 6546053 BACKGROUND

• Wiesneth M, Schreiner T, Friedrich W, Bunjes D, Duncker C, Krug E, Maccari B, Muller S, Nowak S, Kubanek B. Mobilization and collection of allogeneic peripheral blood progenitor cells for transplantation. Bone Marrow Transplant. 1998 Jun;21 Suppl 3:S21-4.

  PMID: 9712487 BACKGROUND

MeSH Terms

Conditions

Hypocalcemia

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 22, 2002
• First Posted: June 24, 2002
• Study Start: June 1, 2002
• Study Completion: February 1, 2004
• Last Updated: March 4, 2008

Record last verified: 2004-02

Locations

US (1)