blood clothing system
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Coagulation activation markers F1+2 and ETP. If increased, the following will be tested: thrombin-antithrombin complexes (TAT), factor VII:C. • Endothelial cell activation and platelet activation markers von Willebrand factor antigen (vWf:Ag) and von Willebrand factor activity (vWf:RiCof). If increased, the following will be tested: thrombomodulin, P-selectin. • Clotting factor VIII activity (fVIII:C). • Fibrinolysis activation markers: plasmin-antiplasmin complexes (PAP) and D-dimer. If increased, the following will be tested: tissue-type Plasminogen Activator (t-PA), urokinase-type plasminogen activator (u-PA), Plasminogen Activator Inhibitor-1 (PAI-1) activity and antigen. • Blood coagulation time: PT, aPTT. | — |
Countries
Netherlands