US2015127078A1PendingUtilityA1

Method of Determining Hypoxia

Assignee: CALMARK SWEDEN AKTIEBOLAGPriority: Oct 13, 2006Filed: Jan 8, 2015Published: May 7, 2015
Est. expiryOct 13, 2026(~0.2 yrs left)· nominal 20-yr term from priority
A61B 5/14546G01N 33/492A61B 5/1405G01N 2333/904A61B 10/0045C12Q 1/32A61B 5/4362A61F 7/00A61B 5/14542A61B 10/0048A61B 5/412G01N 2333/91188A61B 5/157G01N 2800/7038A61B 2503/02C12Q 1/52G01N 33/573A61B 5/150015G01N 2800/2871
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Claims

Abstract

A method of determining hypoxia in fetal scalp blood sampled during labor including the determination of total lactate dehydrogenase (LDH) in plasma obtained from the sample. The method can include the additional determination of K, Mg, Ca, AST, ALT, lactate in the plasma and/or blood. Increased values of one or more of LDH, Mg, Ca, AST, ALT, lactate are indicative of hypoxia in the fetus. Also disclosed is the use of a plasma separation apparatus in the method.

Claims

exact text as granted — not AI-modified
1 . A method of assessing hypoxia at a tissue site of a mammal, comprising:
 a. collecting a blood sample from the tissue site, said blood sample comprising plasma and blood cells;   b. separating the plasma from the blood cells;   c. determining the amount of LDH in the plasma; and   d. assessing the presence of hypoxia at the tissue site from the amount of LDH in the plasma.   
     
     
         2 . The method of  claim 1 , further comprising determining the amount of at least one additional prognostic marker in the plasma selected from the group consisting essentially of K, Mg, Ca, AST, ALT and lactate. 
     
     
         3 . The method of  claim 1 , wherein the volume of the blood sample comprises from 5 μL to 150 μL. 
     
     
         4 . The method of  claim 1 , wherein the blood sample is collected prior to a medical procedure and further comprising:
 a. collecting a second blood sample after a medical procedure, said blood sample comprising plasma and blood cells;   b. separating the plasma from the blood cells of the second blood sample; and   c. determining the total amount of LDH in the plasma of the second blood sample.   
     
     
         5 . The method of  claim 1 , wherein the blood sample is collected from one or more of a specific organ, cerebrospinal fluid, urine, or intraperitoneal fluid of a mammal during a surgical procedure. 
     
     
         6 . The method of  claim 5 , wherein the organ comprises a mammal's aorta. 
     
     
         7 . The method of  claim 1 , wherein the blood sample is collected from an organ to be transplanted into a mammal of need for said organ. 
     
     
         8 . The method of  claim 1 , wherein the blood sample is collected prior to transplantation surgery. 
     
     
         9 . The method of  claim 8 , wherein the organ comprises a liver. 
     
     
         10 . The method of  claim 1 , wherein the determination of hypoxia allows the prediction of brain injury after prenatal asphyxia. 
     
     
         11 . The method of  claim 10 , further comprising determining the amount of at least one additional prognostic marker in the plasma selected from the group consisting essentially of AST, ALT and lactate. 
     
     
         12 . The method of  claim 10 , further comprises providing hypothermia treatment to a mammal in need thereof, wherein the determination of LDH in the plasma indicate delayed cell death in a mammal's brain. 
     
     
         13 . The method of  claim 1 , wherein determining the total amount of LDH in the plasma allows the assessment of blood circulation to a mammal's limbs before, during, and after a medical or surgical treatment. 
     
     
         14 . A method of determining acute hypoxia in fetal scalp blood, comprising collecting a blood sample during labor and treating the blood sample to look for at least one indication to determine hypoxia characterized in that it comprises the determination of total lactate dehydrogenase (LDH) in plasma obtained from the sample. 
     
     
         15 . The method of  claim 14 , further comprising the comparison of LDH so determined with LDH determined in plasma obtained from fetal scalp blood sampled during partum from a fetus in a non-hypoxic state. 
     
     
         16 . The method of  claim 14 , additionally comprising the determination of one or several members of the group consisting of K, Mg, Ca, AST, ALT, and lactate in said scalp blood and/or said plasma. 
     
     
         17 . The method according to  claim 14  characterized in that sample is collected on a disposable device including means for separation of plasma and a compartment arranged to perform detection of LDH. 
     
     
         18 . Testing system for performing the method according to  claim 14 , said testing system comprising a disposable device having a blood sample collecting portion, a plasma separation device and a compartment arranged to indirectly or directly determine the total lactate dehydrogenase (LDH) in the plasma. 
     
     
         19 . Testing system according to  claim 18 , characterized in that there is a number of detection compartments arranged on the card, wherein preferably each one of said compartments is connected to an upstream compartment with a reagent. 
     
     
         20 . Testing system according to  claim 18 , characterized in that said body is arranged with a unique code and preferably that said instrument is arranged with a reader. 
     
     
         21 . Testing system according to  claim 18 , characterized in that said disposable device includes a compartment arranged with dry chemical means for visual detection.

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