## Protocol Section
### Identification Module
**NCT ID:** NCT02712879

**Acronym:** SPO

**Brief Title:** Moderate Bleeding in Cardiac Surgery Post Operative

**Official Title:** Bleeding Moderate Postoperative Cardiac Surgery and Prognostic Implications Anemia and Postoperative Transfusion: Prospective, Observational, Descriptive.

#### Organization Study ID Info
**ID:** UF9695
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Montpellier
### Status Module
#### Completion Date
**Date:** 2016-06-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-04-20

**Type:** ACTUAL

**Last Update Submit Date:** 2022-04-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-06-30

**Type:** ACTUAL

#### Start Date
**Date:** 2016-03-11

**Type:** ACTUAL

**Status Verified Date:** 2022-04

#### Study First Post Date
**Date:** 2016-03-18
**Type:** ESTIMATED
**Study First Submit Date:** 2016-03-04
**Study First Submit QC Date:** 2016-03-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Montpellier

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.

**Detailed Description:** Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.

Secondary objectives:

To evaluate the kinetics of moderate SPORT and its impact on anemia and postoperative transfusion.

To evaluate the prognostic impact of the SPO moderate in terms of post-operative complications.

Determine predictors of moderate SPO.

### Conditions Module

**Conditions:**

- Heart Surgery

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 303

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Hourly blood loss in drains during the first twelve hours

**Measure:** Evolution of blood loss per hour drains

**Time Frame:** Hourly blood loss in drains during the first twelve hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients in the postoperative intensive care in cardiac surgery

Exclusion Criteria:

* Patients who received a heart transplant, a heart surgery beating, cardiac support establishment of long duration, or have a disease that alters the coagulation.

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** patients admitted to intensive care after surgery for heart surgery

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Montpellier

**Country:** France

**Facility:** UHMontpellier

**Zip:** 34700

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital, Montpellier

**Name:** Marine SAOUR, CCA

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Bleeding

- ID: M4070

- Name: Anemia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006470

- Term: Hemorrhage

### Misc Info Module

- Version Holder: 2024-05-24
