BLEEDING: Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses
Sponsor
Manuel Monreal (Other)
Overall Status
Completed
CT.gov ID
NCT04380779
Collaborator
(none)
2,430
1
6
404.2
Study Details
Study Description
Brief Summary
The main objectives are:
-
To establish the prevalence of major bleeding in patients treated with higher than recommended thromboprophylaxis doses.
-
To identify variables associated to higher risk of bleeding.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
2430 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses (BLEEDING Study)
Actual Study Start Date
:
Apr 13, 2020
Actual Primary Completion Date
:
Oct 13, 2020
Actual Study Completion Date
:
Oct 13, 2020
Outcome Measures
Primary Outcome Measures
- Bleeding events and complications [30 days]
Study endpoints are clinically recognized (and objectively confirmed) major and minor bleeding complications, and death.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses.
-
Admission to hospital.
Exclusion Criteria:
- Patients treated with ECMO (Extracorporeal membrane oxygenation).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Manuel Monreal | Badalona | Barcelona | Spain | 08916 |
Sponsors and Collaborators
- Manuel Monreal
Investigators
- Study Chair: Manuel Monreal, Germans Trias i Pujol Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Manuel Monreal,
Professor of Internal Medicine,
Foundation for the study of VTE diseases. (FUENTE)
ClinicalTrials.gov Identifier:
NCT04380779
Other Study ID Numbers:
- BLEEDING042020
First Posted:
May 8, 2020
Last Update Posted:
Dec 14, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: