dinesh
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2006-05-06 14:47
(6167 d 07:50 ago)

Posting: # 111
Views: 9,973
 

 justification for elevated lab parameters [Study Per­for­mance]

hi,
what can be told as a justification for a ALT level of 120iu/l in the screening sample.
p.s: volunteer was included in the study inspite of the derranged parameter,
Helmut
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2006-05-06 15:37
(6167 d 07:00 ago)

@ dinesh
Posting: # 112
Views: 8,136
 

 justification for elevated lab parameters

Hi dinesh,

I assume you are talking about alanine aminotransferase in serum (aka SGPT - serum glutamic-pyruvic transaminase) ;-)

What is your reference range (different for females/males and the method used)? - 120 U/l is about 2 - 4 times the upper limit.

Below the reference ranges [U/l] from three of our contract laboratories:
<31, 10-35,  5-38 (females)
<41, 10-50, 10-50 (males)

The result should be assessed in synopsis with other liver enzymes (e.g., ALP, AST); besides liver injury (e.g., chronic hepatitis) strenuous excercise may also increase ALT levels.
Are there other results from previous screenings available? The reference range includes 95% of the population, maybe the subject has a history of elevated values...
A single deviation may be assessed as not clinically significant by the investigator.
What was the result in the post-study evaluation?

If the volunteer was erroneously included in the study, you must report it as a protocol deviation and discuss the relevance on the outcome of the study (see above).

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dinesh
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2006-05-06 16:10
(6167 d 06:27 ago)

@ Helmut
Posting: # 114
Views: 7,929
 

 justification for elevated lab parameters

hi,
the referance range is 15-40 iu/l... he is a male volunteer.. post study sample value is 122iu/l ( pre study:120iu/l)... can any justification be given on medical grounds rather than considering it as a protocol deviation?
Helmut
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2006-05-06 16:58
(6167 d 05:39 ago)

@ dinesh
Posting: # 115
Views: 7,910
 

 justification for elevated lab parameters

Hi dinesh,

so the elevated value is:
  1. 3times the upper limit, and
  2. consistent within the subject.
You must distinguish between two cases:
  1. the subject was erroneously included -> that's a protocol deviation
  2. the subject was intentionally included
    1. was rated as 'not clinical significant' by the investigator in the CRF/lab. prinout: everything should be fine (it's the personal/professional responsibility of the investigator)
    2. was not rated 'ncs': should be corrected during the review of original data (dated and signed by the investigator)
The post-study value must be rated as 'not clinical significant' as well, because 'clinical significant' abnormal values should have been commented by the investigator, must have been documented as an adverse event and generally would trigger a follow-up exam.

For potential explanations see my first post, but I'm not a medical doctor/physician - you should talk with a specialist for laboratory medicine/clinical chemistry.

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