Purpura Fulminans Clinical Trial
— hOPeFULOfficial title:
Short and Long-term Outcomes of Purpura Fulminans in Adults
| Verified date | March 2018 |
| Source | Henri Mondor University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Purpura fulminans (PF) is a rare life-threatening infectious disease characterized by the association of a sudden and extensive purpura together with acute circulatory failure. The mortality of PF has been reported to be as high as 50% in previous adult series. Additionally, patients surviving to the early phase of PF are exposed to a high risk of limb amputation. The hOPeFUL study aims at assessing the short and long term outcomes of adult patients admitted in the intensive care unit for a purpura fulminans.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | March 8, 2018 |
| Est. primary completion date | March 8, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients admitted in the intensive care unit between 2010 and 2016 for an infectious purpura fulminans and discharged alive Exclusion Criteria: - Age < 18 years - Non infectious purpura - Infective endocarditis |
| Country | Name | City | State |
|---|---|---|---|
| France | Aulnay sous Bois Hospital | Aulnay-sous-Bois | |
| France | Caen University Hospital | Caen | |
| France | Chartres Hospital | Chartres | |
| France | Louis Mourier Hospital | Colombes | |
| France | Henri Mondor Hospital | Créteil | |
| France | Grenoble University Hospital | Grenoble | |
| France | La Roche sur Yon Hospital | La Roche sur Yon | |
| France | Versailles Hospital | Le Chesnay | |
| France | Le Havre Hospital | Le Havre | |
| France | Lilles University Hospital | Lilles | |
| France | Edouard Herriot Hospital | Lyon | |
| France | Melun Hospital | Melun | |
| France | Nice University Hospital | Nice | |
| France | Orléans Hospital | Orléans | |
| France | Bichat University Hospital | Paris | |
| France | Cochin Hospital | Paris | |
| France | Pitié-Salpétrière Hospital | Paris | |
| France | Saint Louis Hospital | Paris | |
| France | Saint-Antoine Hospital | Paris | |
| France | Poissy Hospital | Poissy | |
| France | Poitiers University Hospital | Poitiers | |
| France | Clinique Gallien | Quincy-sous-Sénart | |
| France | Reims University Hospital | Reims | |
| France | Rennes University Hospital | Rennes | |
| France | Roubaix Hospital | Roubaix | |
| France | Tours University Hospital | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| Henri Mondor University Hospital | Fondation de France |
France,
Giraud T, Dhainaut JF, Schremmer B, Regnier B, Desjars P, Loirat P, Journois D, Lanore JJ. Adult overwhelming meningococcal purpura. A study of 35 cases, 1977-1989. Arch Intern Med. 1991 Feb;151(2):310-6. — View Citation
Lerolle N, Carlotti A, Melican K, Aubey F, Pierrot M, Diehl JL, Caille V, Hékimian G, Gandrille S, Mandet C, Bruneval P, Dumenil G, Borgel D. Assessment of the interplay between blood and skin vascular abnormalities in adult purpura fulminans. Am J Respir — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hospital mortality | factors associated with hospital mortality (and rate of amputation in the hospital) will be identified using a polytomous logistic regression model | day 60 | |
| Primary | Rate of amputation in the hospital; | factors associated with rate of amputation in the hospital (and hospital mortality) will be identified using a polytomous logistic regression model | day 60 | |
| Primary | Long-term outcome measure: Physical dimension scale of the SF-36 questionnaire | This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans | Within 6 years of hospital discharge | |
| Secondary | Mental component score of the SF-36 score | This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans | Within 6 years of hospital discharge | |
| Secondary | Activity of daily living (ADL score) | This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans | Within 6 years of hospital discharge | |
| Secondary | Hospital anxiety and depression scale | This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans | Within 6 years of hospital discharge | |
| Secondary | Impact of Event Scale | This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans | Within 6 years of hospital discharge | |
| Secondary | Physical dimension scale of the SF-36 questionnaire | This variable will be compared between patients with purpura fulminans who were and those who were not amputated | Within 6 years of hospital discharge | |
| Secondary | Mental component score of the SF-36 score | This variable will be compared between patients with purpura fulminans who were and those who were not amputated | Within 6 years of hospital discharge |