The influence of ACTH on blood coagulatio

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Phase 1: Patients and healthy volunteers
a. Adults >= 18 years old.
b. Informed consent.;Phase 2. Cases
a. Adults >= 18 years old.
b. Informed consent.
c. Primary adrenal insufficiency defined as:
1) Bilateral adrenalectomy
2) Auto-immuun adrenalitis
3) Congenital adrenal hypoplasia/ adrenal dysgenesis

Exclusion Criteria

Phase 1.
a. Use of oral contraceptive agents, corticosteroids, anticoagulants, platelet aggregation inhibitors and NSAIDs.
b. Known or suspected hypersensitivity to Synacthen; poorly controlled asthma; pregnancy and lactation; untreated acute or chronic bacterial, fungal and viral infections; diabetes mellitus type II; Cushing's syndrome; refractory congestive heart failure; active or latent peptic ulcer; acute psychosis; non-specific ulcerative colitis; diverticulitis; recent intestinal anastomosis; renal insufficiency (kreatinin > 200 umol/l); liver failure (ALAT, ASAT, yGT, AF > 3 times normal value); hypertension (systolic pressure above 140); myasthenia gravis or malignancy.;Phase 2.
1) Congenital adrenal hyperplasia (CAH)
2) Secondary adrenal insufficiency
3) Tertiary adrenal insufficiency
4) Primairy adrenal insufficiency induced by:
a. Steroid synthesis inhibitors (e.g., metyrapone, ketoconazole, aminoglutethimide)
b. Adrenolytic agents (o,p'DDD, suramin)
c. Glucocorticoid antagonists (RU 486)
d. Metastatic neoplasia/infiltration
e. Criteria mentioned at phase 1 with the exception of corticosteroid use.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Coagulation activation markers F1+2 and ETP. If increased, the following will<br /><br>be tested: thrombin-antithrombin complexes (TAT), factor VII:C.<br /><br>• Endothelial cell activation and platelet activation markers von Willebrand<br /><br>factor antigen (vWf:Ag) and von Willebrand factor activity (vWf:RiCof). If<br /><br>increased, the following will be tested: thrombomodulin, P-selectin.<br /><br>• Clotting factor VIII activity (fVIII:C).<br /><br>• Fibrinolysis activation markers: plasmin-antiplasmin complexes (PAP) and<br /><br>D-dimer. If increased, the following will be tested: tissue-type Plasminogen<br /><br>Activator (t-PA), urokinase-type plasminogen activator (u-PA), Plasminogen<br /><br>Activator Inhibitor-1 (PAI-1) activity and antigen.<br /><br>• Blood coagulation time: PT, aPTT.</p><br>

Secondary Outcome Measures