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NCT03535090
Coagulation After Intravenous Methylprednisolone Administration
trial testing Methylprednisolone in Graves' Disease in 26 participants. Completed in 31 December 2014.
31 December 2014
Quick facts
| Lead sponsor | Piotr Miskiewicz |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 26 |
| Start date | 1 January 2011 |
| Primary completion | 31 December 2014 |
| Estimated completion | 31 December 2014 |
Drugs / interventions tested
- Methylprednisolone (methylprednisolone) — full drug profile →
Conditions studied
- Graves' Disease — all drugs for Graves' Disease →
- Graves Ophthalmopathy — all drugs for Graves Ophthalmopathy →
- Blood Coagulation — all drugs for Blood Coagulation →
- Venous Thromboembolism — all drugs for Venous Thromboembolism →
Sponsor
Piotr Miskiewicz
Who can join
18 and older, any sex, with Graves' Disease or Graves Ophthalmopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The alterations of coagulation and fibrinolysis parameters have been described in patients with endogenous Cushing's syndrome (CS) and those treated with glucocorticosteroids (GCs). The change in hemostatic process is associated with an increased risk of venous thromboembolic events (VTE) and pulmonary embolism (PE). Anticoagulation prophylaxis reduces thromboembolic complications in endogenous and exogenous hypercortisolism. The impact of the intravenous GCs therapy on hypercoagulability, however, remains unclear and perplexing. According to the European Group On Graves' Orbitopathy (EUGOGO), patients with active, severely symptomatic and sight-threatening Graves' orbitopathy (GO) should be treated with high dose intravenous methylprednisolone (IVMP) pulses. There are, however, reports of fatal side effects that may be associated with this therapy (e.g.: PE, myocardial infarction, severe cerebrovascular events, acute liver damage and sudden death). For this reason, the cumulative dose of IVMP should not exceed 8 g within each treatment course, and pulses should not be given on consecutive or alternate days, except for the case of dysthyroid optic neuropathy. Nevertheless, even smaller cumulative therapy may be associated with fatal cardiovascular complications. Hence the aim of our study was to evaluate the effects of IVMP therapy on hemostatic process in patients with GO. All of patients were treated according to EUGOGO recommendations with standard doses of methylprednisolone with standard recommended schedule. Inclusion criterion for the therapy was according to EUGOGO guidelines moderate-to-severe and active GO (12 pulses of IVMP 6x0.5g followed by 6x0.25g every week).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03535090
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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- NCT07265258 — A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease · Phase 4 · not yet recruiting
Other recruiting trials for Graves' Disease
Currently open trials in the same condition.
- NCT06984627 — A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease · Phase 2 · recruiting
- NCT07369063 — Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease · Phase 2 · recruiting
- NCT06068179 — Graves' Disease Remission Study: MycoMeth Combo · Phase 2, PHASE3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03535090 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Piotr Miskiewicz
- Last refreshed: 24 May 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03535090.
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