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The influence of ACTH on blood coagulation

The influence of ACTH on blood coagulation - ACTH study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34344
Enrollment
30
Registered
2010-05-31
Start date
2011-02-25
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood clothing system

Interventions

Phase 1: We will first carry out a pilot study in which we will perform one short ACTH stimulation test on 10 patients in light of routine laboratory testing. Ten healthy volunteers will serve as co

Sponsors

Slotervaartziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)