COVID-19BLEEDINGNCT04380779
Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses
An observational study of COVID-19, run by Manuel Monreal at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- How many people
- 2,430 participants
- Where
- 1 siteSpain
- Study dates
- 13 Apr 2020to 13 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses and admitted to hospital
Who may be able to join
- Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses.
- Admission to hospital.
Who cannot join
- Patients treated with ECMO (Extracorporeal membrane oxygenation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses (BLEEDING Study)
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.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding events and complications
Study endpoints are clinically recognized (and objectively confirmed) major and minor bleeding complications, and death.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start13 Apr 2020
- Primary completion13 Oct 2020
- Study completion13 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manuel Monreal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manuel Monreal, Foundation for the study of VTE diseases. (FUENTE)
- Investigators
- Manuel Monreal, Study chair, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380779
- Sponsor's protocol ID
- BLEEDING042020
- Acronym
- BLEEDING
- Status last verified
- Dec 2020
- First submitted
- 7 May 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses (BLEEDING Study)
- ClinicalTrials.gov ID
- NCT04380779
- Acronym / sponsor ID
- BLEEDING / BLEEDING042020
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,430 participants (actual)
- Lead sponsor
- Manuel MonrealUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses and admitted to hospital
Key inclusion criteria (2 listed)
- Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses.
- Admission to hospital.
Key exclusion criteria (1 listed)
- Patients treated with ECMO (Extracorporeal membrane oxygenation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bleeding events and complications
Time frame: 30 days
Study endpoints are clinically recognized (and objectively confirmed) major and minor bleeding complications, and death.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Monreal study chair
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Manuel Monreal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding events and complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.