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Protocol - Lactate Dehydrogenase Level

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Description:

This protocol provides instructions for drawing, processing, and storing blood according to the National Health and Nutrition Examination Survey (NHANES) methods. Because there are many comparable assays for measuring lactate dehydrogenase, the protocol also provides basic guidelines to aid comparability among different studies.

Protocol:

The following is a summary version of the full National Health and Nutrition Examination Survey 2011-2012 protocol.

Exclusion Criteria

Persons will be excluded from this component if they:

  • Report that they have hemophilia; or
  • Report that they have received cancer chemotherapy in the last 4 weeks

SP = Sample Person.

1. Do you have hemophilia?

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers "Yes," the SP is excluded from the blood draw.

If SP answers "No" or "Don’t Know," blood is drawn from the SP.

2. Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks?

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers "Yes," the SP is excluded from the blood draw.

If SP answers "No" or "Don’t Know," blood is drawn from the SP.

Venipuncture Procedures

Editor’s Note: Please review chapter 4 of the Laboratory Procedures Manual from the 2011-2012 National Health and Nutrition Examination Survey (NHANES) for a full description of phlebotomy procedures. This manual is posted here, and is also available at the NHANES website: 2011-2012 NHANES Laboratory Procedures Manual

Venipuncture should generally be performed using the median cubital, cephalic, or basilic veins in the left arm unless this arm is unsuitable. If the veins in the left arm are unsuitable, look for suitable veins on the right arm. If the veins in the antecubital space on both arms are not suitable, then look for veins in the forearm or dorsal side of the hand on the left arm/hand and then the right arm/hand.

Recording the Results of the Venipuncture Procedure

Immediately after completing the venipuncture, record the results of the blood draw, the reasons for a tube not being drawn according to the protocol, and any comments about the venipuncture.

Blood Processing

Please review chapter 8 of the Laboratory Procedures Manual from the National Health and Nutrition Examination Survey 2011-2012 for a full description of blood processing procedures: 2011-2012 NHANES Laboratory Procedures Manual

  • Allow the blood to clot by setting aside for 30 to 45 minutes at room temperature. Do not clot for more than an hour.
  • Centrifuge the tube at room temperature to separate the serum and aliquot into an appropriate storage tube.
  • Determine if the serum is hemolyzed, turbid, lipemic, or icteric. If so, enter a comment to describe the serum.

Pediatric blood collection - volumes may change depending on the laboratory but volumes as low as 0.5mL in a red top, green top or no additive tube/Microtainer™ have been used.

Laboratory Assay for Lactate Dehydrogenase

The Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group notes that there are a number of different assays and instruments that are appropriate to measure the concentration of lactate dehydrogenase. Once an assay is chosen for a particular study, the Working Group recommends that no changes in the protocol be made over the course of the study. To aid comparability, the Working Group recommends that the investigator record the make and manufacturer of equipment used and the repeatability and coefficients of variation for the assay.

Reference Ranges for Lactate Dehydrogenase:

Age (years)

IU/L

0-5

140-304

5-10

142-290

10-15

115-257

>15

93-198

Protocol Name from Source:

This section will be completed when reviewed by an Expert Review Panel.

Availability:

Publicly available

Personnel and Training Required

Phlebotomist

Equipment Needs

Laboratory with the ability to perform the lactate dehydrogenase assay.

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Bioassay

Life Stage:

Toddler, Child, Adolescent, Adult, Senior, Pregnancy

Participants:

Individuals age 1 year and older.

Specific Instructions:

The National Health and Nutrition Examination Survey (NHANES) instructions for drawing, processing, and storing blood provide a standard methodology used successfully for many years to ensure comparable results across study sites. However, the Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group notes that certain aspects (e.g., exclusion criteria) of the NHANES protocol are study specific and might not be applicable to all types of studies (e.g., sickle cell disease). Investigators who want to include participants that have hemophilia or have received cancer chemotherapy in the last 4 weeks will need to implement special venipuncture procedures.

Lactate dehydrogenase (LDH) levels can be combined with other indirect markers of hemolysis (Aspartate Aminotransferase Level, Haptoglobin Level, Reticulocyte, and Bilirubin Level) to derive a hemolytic component for sickle cell disease patients.

LDH levels are increased with ineffective erythropoiesis and damage to liver, muscles, brain, heart, lungs, and other organs which are impacted by sickle cell disease.

LDH analysis is typically preformed via a serum assay using a serum gel separator collection tube.

Selection Rationale

The Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group selected the National Health and Nutrition Examination Survey 2011-2012 protocol as the best standardized methodology for blood collection, processing and storage.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Laboratory Procedure Lactate Dehydrogenase Result Unspecified Value 2597018 CDE Browser
Process and Review

This section will be completed when reviewed by an Expert Review Panel.

Source

Centers for Disease Control and Prevention (CDC). (2011). National Health and Nutrition Examination Survey Questionnaire, Laboratory Procedures Manual. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

Burtis, C. A., Ashwood, E. R., & Bruns, D.E. (2006). Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th ed. St. Louis, MO: Elsevier Saunders.

General References

Potoka, K. P. & Gladwin, M. T. (2015). Vasculopathy and pulmonary hypertension in sickle cell disease. American Journal of Physiology - Lung Cellular and Molecular Physiology, 308: L314-L324

Nouraie, M., Lee, J. S., Zhang, Y., Kanias, T., Zhao, X., Xiong, Z., Oriss, T. B., Zeng, Q., Kato, G. J., Gibbs, J. S., Hildesheim, M. E., Sachdev, V., Barst, R. J., Machado, R. F., Hassell, K. L., Little, J. A., Schraufnagel, D. E., Krishnamurti, L., Novelli, E., Girgis, R. E., Morris, C.R., Rosenzweig, E. B., Badesch, D. B., Lanzkron, S., Castro, O. L., Goldsmith, J. C., Gordeuk, V. R., Galdwin, M. T., & Walk-PHASST Investigators and Patients. (2013). The relationship between the severity of hemolysis, clinical manifestations and risk of death in 415 patients with sickle cell anemia in the US and Europe. Haematologica, 98(3), 464-472.

Sachdev, V., Kato, G. J., Gibbs, J. S., Barst, R. J., Machado, R. F., Nouraie, M., Hassell, K. L., Little, J. A., Schraufnagel, D. E., Krishnamurti, L., Novelli, E. M., Girgis, R. E., Morris, C. R., Rosenzweig, E. B., Badesch, D. B., Lanzkron, S., Castro, O. L., Taylor, J. G. 6th, Hannoush, H., Goldsmith, J. C., Gladwin, M. T., Gordeuk, V. R., & Walk-PHASST Investigators. (2011). Echocardiographic markers of elevated pulmonary pressure and left ventricular diastolic dysfunction are associated with exercise intolerance in adults and adolescents with homozygous sickle cell anemia in the United States and United Kingdom. Circulation, 124(13), 1452-1460.

Protocol ID:

811001

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX811001_Lactate_Dehydrogenase_Age PX811001030000 Age 4 N/A
PX811001_Lactate_Dehydrogenase_Assay_Repeatability PX811001110000 Repeatability of the lactate dehydrogenase assay. 4 N/A
PX811001_Lactate_Dehydrogenase_Blood_DrawTube_Deviation PX811001050000 Record reasons for a tube not being drawn according to the protocol. 4 N/A
PX811001_Lactate_Dehydrogenase_Blood_Draw_Results PX811001040000 Record the results of the blood draw. 4 N/A
PX811001_Lactate_Dehydrogenase_Chemotheraphy_4weeks PX811001020000 Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks? 4 N/A
PX811001_Lactate_Dehydrogenase_Coefficients_Variation_Assay PX811001120000 Coefficients of variation of the lactate dehydrogenase assay. 4 N/A
PX811001_Lactate_Dehydrogenase_Concentration PX811001080000 Lactate dehydrogenase level 4 N/A
PX811001_Lactate_Dehydrogenase_Equipment_Make PX811001090000 Make of the equipment used to perform the lactate dehydrogenase assay. 4 N/A
PX811001_Lactate_Dehydrogenase_Equipment_Manufacturer PX811001100000 Manufacturer of the equipment used to perform the lactate dehydrogenase assay. 4 N/A
PX811001_Lactate_Dehydrogenase_Hemophilia PX811001010000 Do you have hemophilia? 4 N/A
PX811001_Lactate_Dehydrogenase_Serum_Description PX811001070200 If serum is hemolyzed, turbid, lipemic, or iteric, then describe. 4 N/A
PX811001_Lactate_Dehydrogenase_Serum_Determination PX811001070100 Determine if the serum is hemolyzed, turbid, lipemic, or icteric. 4 N/A
PX811001_Lactate_Dehydrogenase_Venipuncture_Comments PX811001060000 Record any comments about the venipuncture. 4 N/A
Research Domain Information
Measure Name:

Lactate Dehydrogenase Level

Release Date:

July 30, 2015

Definition

A bioassay to measure levels of lactate dehydrogenase, an enzyme released during tissue damage and injury.

Purpose

Elevated lactate dehydrogenase (LDH) levels are reflective of increased hemolysis in sickle cell disease. Additionally, elevated LDH levels are associated with cancer, tissue damage, hemolysis and anemia, and infectious diseases such as HIV and bacterial meningitis.

Keywords

Lactate dehydrogenase, LDH, hemolysis, hemoglobin, sickle cell disease, SCD, anemia, pulmonary hypertension, PH, cutaneous leg ulceration, hypoxemia, hemolytic anemia, chronic kidney disease, CKD, vasculopathy, stroke, hemolytic component, HIV, bacterial menigitis