## Protocol Section
### Identification Module
**NCT ID:** NCT04380779

**Acronym:** BLEEDING

**Brief Title:** Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses

**Official Title:** Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses (BLEEDING Study)

#### Organization Study ID Info
**ID:** BLEEDING042020
#### Organization
**Class:** OTHER
**Full Name:** Foundation for the study of VTE diseases. (FUENTE)
### Status Module
#### Completion Date
**Date:** 2020-10-13

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-12-14

**Type:** ACTUAL

**Last Update Submit Date:** 2020-12-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-10-13

**Type:** ACTUAL

#### Start Date
**Date:** 2020-04-13

**Type:** ACTUAL

**Status Verified Date:** 2020-12

#### Study First Post Date
**Date:** 2020-05-08
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-07
**Study First Submit QC Date:** 2020-05-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Manuel Monreal

#### Responsible Party

**Investigator Affiliation:** Foundation for the study of VTE diseases. (FUENTE)

**Investigator Full Name:** Manuel Monreal

**Investigator Title:** Professor of Internal Medicine

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### 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.

### Conditions Module

**Conditions:**

- COVID-19

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 2430

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Bleeding events and complications

**Time Frame:** 30 days

### 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).

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Badalona

**Country:** Spain

**Facility:** Manuel Monreal

**State:** Barcelona

**Zip:** 08916

#### Overall Officials

**Official 1:**

**Affiliation:** Germans Trias i Pujol Hospital

**Name:** Manuel Monreal

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

### Misc Info Module

- Version Holder: 2024-05-24
