Protocol - Lactate Dehydrogenase Level
- Aspartate Aminotransferase Level
- Bilirubin Level
- Complete Blood Count (CBC)
- Haptoglobin Level
- Liver Function - Assay
- Reticulocyte Count
- Serum or Plasma Ferritin
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.
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.
The Sickle Cell Disease Curative Therapy Working Group recommends that lactate dehydrogenase (LDH) levels be determined in sickle cell patients undergoing hematopoietic cell transplant at one time point pre-transplant (baseline) and 100 days, six months, and annually post-transplant.
Availability
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 |
Personnel and Training Required
Phlebotomist
Equipment Needs
Laboratory with the ability to perform the lactate dehydrogenase assay.
Requirements
| Requirement Category | Required |
|---|---|
| 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
Lifestage
Toddler, Child, Adolescent, Adult, Senior, Pregnancy
Participants
Individuals age 1 year and older.
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
| Standard | Name | ID | Source |
|---|---|---|---|
| Human Phenotype Ontology | Abnormal lactate dehydrogenase activity | HP:0045040 | HPO |
| caDSR Form | PhenX PX811001 - Lactate Dehydrogenase Level | 6252569 | caDSR Form |
Derived Variables
Hemolytic Component:
Lactate dehydrogenase levels can be combined with other indirect markers of hemolysis (Bilirubin Level, Reticulocyte Count, Aspartate Aminotransferase Level, and Haptoglobin Level) by principle component analysis (PCA) to derive a hemolytic component for sickle cell disease patients.
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.
Process and Review
Not applicable.
Protocol Name from Source
National Health and Nutrition Examination Survey Questionnaire (NHANES), Laboratory Procedures Manual, 2011
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 Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX811001_Lactate_Dehydrogenase_Age | ||||
| PX811001030000 | Age | Variable Mapping | ||
| PX811001_Lactate_Dehydrogenase_Assay_Repeatability | ||||
| PX811001110000 | Repeatability of the lactate dehydrogenase assay. | N/A | ||
| PX811001_Lactate_Dehydrogenase_Blood_DrawTube_Deviation | ||||
| PX811001050000 | Record reasons for a tube not being drawn more | N/A | ||
| PX811001_Lactate_Dehydrogenase_Blood_Draw_Results | ||||
| PX811001040000 | Record the results of the blood draw. | N/A | ||
| PX811001_Lactate_Dehydrogenase_Chemotheraphy_4weeks | ||||
| PX811001020000 | Have you received cancer chemotherapy in the more | Variable Mapping | ||
| PX811001_Lactate_Dehydrogenase_Coefficients_Variation_Assay | ||||
| PX811001120000 | Coefficients of variation of the lactate more | N/A | ||
| PX811001_Lactate_Dehydrogenase_Concentration | ||||
| PX811001080000 | Lactate dehydrogenase level | Variable Mapping | ||
| PX811001_Lactate_Dehydrogenase_Equipment_Make | ||||
| PX811001090000 | Make of the equipment used to perform the more | N/A | ||
| PX811001_Lactate_Dehydrogenase_Equipment_Manufacturer | ||||
| PX811001100000 | Manufacturer of the equipment used to more | N/A | ||
| PX811001_Lactate_Dehydrogenase_Hemophilia | ||||
| PX811001010000 | Do you have hemophilia? | Variable Mapping | ||
| PX811001_Lactate_Dehydrogenase_Serum_Description | ||||
| PX811001070200 | If serum is hemolyzed, turbid, lipemic, or more | N/A | ||
| PX811001_Lactate_Dehydrogenase_Serum_Determination | ||||
| PX811001070100 | Determine if the serum is hemolyzed, turbid, more | N/A | ||
| PX811001_Lactate_Dehydrogenase_Venipuncture_Comments | ||||
| PX811001060000 | Record any comments about the venipuncture. | N/A | ||
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, "Cardiovascular, Pulmonary, and Renal"
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 811001 | Lactate Dehydrogenase Level |
Publications
There are no publications listed for this protocol.