Prevalence of Severe Bleeding in COVID-19 Patients Treate... | NCT04380779

Studies
Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses

NCT04380779

Sponsor

Manuel Monreal

Status

Completed

Last Update Posted

Dec 14, 2020Actual

Enrollment

2,430Actual

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 13, 2020Actual

Primary Completion Date

Oct 13, 2020Actual

Completion Date

Oct 13, 2020Actual

First Submitted Date

May 7, 2020

First Submission Date that Met QC Criteria

May 7, 2020

First Posted Date

May 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Manuel Monreal, Professor of Internal Medicine, Foundation for the study of VTE diseases. (FUENTE)Sponsor-Investigator

Lead Sponsor

Manuel MonrealOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,430Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bleeding events and complications	Study endpoints are clinically recognized (and objectively confirmed) major and minor bleeding complications, and death.	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses and admitted to hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manuel Monreal	Germans Trias i Pujol Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Manuel Monreal		Badalona	Barcelona	08916	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided