STABACT: ACTH Stability on Whole Blood

• Sponsor: University Hospital, Rouen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04266587
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

ACTH is a peptide secreted by pituitary gland and plays an important role in regulating cortisol secretion. ACTH is determined in plasma by immunoassays using specific antibodies. Its determination is difficult because of instability in whole blood. Several factors which influence ACTH stability in blood before analysis have been identified: temperature, hemolysis, time to centrifugation and presence of protease inhibitors. Published results on ACTH whole blood stability seem contradictory.

The objective of this study is to evaluate the effect of aprotinin in 10 healthy volunteers. ACTH measurements will be performed on cobas e602 (Roche Diagnostics, Mannheim, Germany).

Condition or Disease	Intervention/Treatment	Phase
ACTH	Biological: Blood sampling	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Adrenocorticotropic Hormone Stability on Whole Blood
• Anticipated Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Nov 1, 2020
• Anticipated Study Completion Date: Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy volunteers blood sampling is done on healthy volunteers	Biological: Blood sampling; blood sampling is done on healthy volunteers

Outcome Measures

Primary Outcome Measures

1. ACTH concentration in plasma [8 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult patient aged 18 to 60,

Exclusion Criteria:

• Adult with insufficient venous capital for blood collection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rouen University Hospital	Rouen		France

Sponsors and Collaborators

• University Hospital, Rouen

Investigators

• Principal Investigator: Francois FRAISSINET, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Rouen
• ClinicalTrials.gov Identifier: NCT04266587
• Other Study ID Numbers: 2019/0350/HP
• First Posted: Feb 12, 2020
• Last Update Posted: Jun 29, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 29, 2020