NCT04380779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2020

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

May 7, 2020

Last Update Submit

December 11, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Bleeding events and complications

    Study endpoints are clinically recognized (and objectively confirmed) major and minor bleeding complications, and death.

    30 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses.
  • Admission to hospital.

You may not qualify if:

  • Patients treated with ECMO (Extracorporeal membrane oxygenation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manuel Monreal

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Manuel Monreal

    Germans Trias i Pujol Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 8, 2020

Study Start

April 13, 2020

Primary Completion

October 13, 2020

Study Completion

October 13, 2020

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations

ES(1)