HealthyPhase 3NCT00040235
Magnesium Effects in Apheresis
A Phase 3 study testing magnesium in people with Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- magnesium
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Feb 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: Citrate Effects and Role of Prophylactic Magnesium Administration During Large-Volume Leukapheresis
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.
Read more
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
Read the detailed description
Large volume leukapheresis (LVL) is increasingly used to collect peripheral blood stem cells (PBSCs) and other mononuclear cells (MNC) for hematopoietic and immune reconstitution, with recent emphasis on increased processing volumes. Decreases in divalent cation levels caused by administration of citrate anticoagulant during LVL can be associated with severe donor reactions, and may limit the rate at which blood can be processed. Several donors at NIH experienced citrate-related hypocalcemic tetany during LVL, in response to which we developed standard operating procedures for the routine administration of prophylactic intravenous calcium solutions during longer apheresis procedures. Other centers have utilized heparin to reduce the amount of citrate returned to the donor, however, this exposes the donor to systemic anticoagulation and may be associated with hematomas or clumping of the apheresis product.
We previously determined that citrate administration during apheresis results in significant excretion of calcium and magnesium in the urine during the procedure, and that performance of prolonged or repeated LVL causes significant depletion of blood calcium and magnesium levels. Decreases in calcium levels were ameliorated during procedures performed with prophylactic calcium administration. Our preliminary studies also demonstrated that ionized magnesium levels were markedly reduced during LVL as well as plateletpheresis procedures. The clinical impact of severe, acute decreases in ionized magnesium levels in healthy apheresis donors is not clear, however. Since most of the adverse effects related to citrate administration can be prevented by prophylactic calcium administration, it is unknown what aspect of the remaining discomfort may be attributable to hypomagnesemia. This protocol will focus on determining the contribution of acute hypomagnesemia to citrate-related symptoms during large-volume apheresis, and establishing the role of and indications for prophylactic intravenous magnesium replacement in this setting. The study plan will consist of a prospective, randomized, placebo-controlled, double-blind study. Healthy allogeneic donors will be assigned to one of two treatment groups. One group will receive intravenous magnesium infusions throughout scheduled LVL procedures; the other group will receive equivalent volume infusions of normal saline. Symptoms and blood samples will be obtained by apheresis nurses and laboratory assays will be performed by associate laboratory investigators, all in a blinded fashion.
- Conditions
- Healthy
- Being tested
- magnesium
- Keywords
- Leukapheresis, Hypomagnesemia, Plateletpheresis, Hypocalcemia, Citrate, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesiumProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2002 (estimated)
- Study startJun 2002
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 52 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040235
- Sponsor's protocol ID
- 020234
- Other IDs
- 02-CC-0234
- Status last verified
- Feb 2004
- First submitted
- 22 Jun 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 8874224Hester 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.
PubMed 6546053Wiesneth 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.
PubMed 9712487
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citrate Effects and Role of Prophylactic Magnesium Administration During Large-Volume Leukapheresis
- ClinicalTrials.gov ID
- NCT00040235
- Acronym / sponsor ID
- 020234
- Conditions
- Healthy
- Keywords
- Leukapheresis, Hypomagnesemia, Plateletpheresis, Hypocalcemia, Citrate, Healthy Volunteer, HV, Normal Control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Jun 2002
- Study completion
- Feb 2004
- First posted
- 24 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Large volume leukapheresis (LVL) is increasingly used to collect peripheral blood stem cells (PBSCs) and other mononuclear cells (MNC) for hematopoietic and immune reconstitution, with recent emphasis on increased processing volumes. Decreases in divalent cation levels caused by administration of citrate anticoagulant during LVL can be associated with severe donor reactions, and may limit the rate at which blood can be processed. Several donors at NIH experienced citrate-related hypocalcemic tetany during LVL, in response to which we developed standard operating procedures for the routine administration of prophylactic intravenous calcium solutions during longer apheresis procedures. Other centers have utilized heparin to reduce the amount of citrate returned to the donor, however, this exposes the donor to systemic anticoagulation and may be associated with hematomas or clumping of the apheresis product.
We previously determined that citrate administration during apheresis results in significant excretion of calcium and magnesium in the urine during the procedure, and that performance of prolonged or repeated LVL causes significant depletion of blood calcium and magnesium levels. Decreases in calcium levels were ameliorated during procedures performed with prophylactic calcium administration. Our preliminary studies also demonstrated that ionized magnesium levels were markedly reduced during LVL as well as plateletpheresis procedures. The clinical impact of severe, acute decreases in ionized magnesium levels in healthy apheresis donors is not clear, however. Since most of the adverse effects related to citrate administration can be prevented by prophylactic calcium administration, it is unknown what aspect of the remaining discomfort may be attributable to hypomagnesemia. This protocol will focus on determining the contribution of acute hypomagnesemia to citrate-related symptoms during large-volume apheresis, and establishing the role of and indications for prophylactic intravenous magnesium replacement in this setting. The study plan will consist of a prospective, randomized, placebo-controlled, double-blind study. Healthy allogeneic donors will be assigned to one of two treatment groups. One group will receive intravenous magnesium infusions throughout scheduled LVL procedures; the other group will receive equivalent volume infusions of normal saline. Symptoms and blood samples will be obtained by apheresis nurses and laboratory assays will be performed by associate laboratory investigators, all in a blinded fashion.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8874224Mavroudis 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.
- Background: PubMed 6546053Hester 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.
- Background: PubMed 9712487Wiesneth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing magnesium in people with Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00040235, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.