## Protocol Section
### Identification Module
**NCT ID:** NCT06429943

**Brief Title:** Cerebrolysin in SAH (Subarachnoidal Haemorrhage) - Observational Study

**Official Title:** Cerebrolysin in Patients Diagnosed With SAH - an Observational Cohort Study (PILOT)

#### Organization Study ID Info
**ID:** SAH/2020/2023
#### Organization
**Class:** OTHER
**Full Name:** Pomeranian Medical University Szczecin
### Status Module
#### Completion Date
**Date:** 2023-01-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-10-15

**Type:** ACTUAL

#### Start Date
**Date:** 2021-01-15

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Pomeranian Medical University Szczecin

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** Subarachnoid haemorrhage often affects people in middle age and is associated with high mortality or neurological damage. In recent years, advances in surgical techniques have im-proved the mortality rate. However, there is still need for the research for the optimal possible final effect of treatment. In our study, we've decided to examine the effect of a multimodal approach including Cerebrolysin in the supportive treatment of patients. We've examined the supply of neuroprotective drugs and neuromonitoring.

### Conditions Module

**Conditions:**

- SAH (Subarachnoid Hemorrhage)

**Keywords:**

- SAH

- Cerebrolysin

- neuromonitoring

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 47

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Month

### Arms Interventions Module

#### Arm Group 1

**Description:** Cerebrolysin administration

**Label:** A

#### Arm Group 2

**Description:** without Cerebrolysin administration

**Label:** B

### Outcomes Module

#### Primary Outcomes

**Description:** Glasgow Outcome Scale - 5 points scale, characterizing the patients' deficits

**Measure:** GOS Glasgow Outcome Scale

**Time Frame:** 1 month

#### Secondary Outcomes

**Description:** length of stay in days, that patient spent in hospital/ intensive care unit

**Measure:** LOS Length of Stay

**Time Frame:** hospitalisation time

**Description:** mortality

**Measure:** mortality

**Time Frame:** 1 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* age \>18 years old, diagnosis of SAH, treatment in ICU conditions

Exclusion Criteria:

* age \<18 years, medical history of allergy to Cerebrolysin, acute renal failure, pregnancy, multi organ trauma, death within 48 hours after admission

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The study population is the population of patients diagnosed with SAH, treated in University Hospital no.1 in Szczecin, Poland. Mainly the patients come from the population of westerpomeranian county, but as SAH is an acute disease also patients from the whole region of Poland, treated in the Hospital were included in the study.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Szczecin

**Country:** Poland

**Facility:** Pomeranian Medical University, University Hospital no.1

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020300

- Term: Intracranial Hemorrhages

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Hemorrhage

- ID: M16135

- Name: Subarachnoid Hemorrhage

- Relevance: HIGH

- As Found: Subarachnoid Hemorrhage

- ID: M22113

- Name: Intracranial Hemorrhages

- Relevance: LOW

- As Found: Unknown

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013345

- Term: Subarachnoid Hemorrhage

- ID: D000006470

- Term: Hemorrhage

### Intervention Browse Module - Browse Branches

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: NootAg

- Name: Nootropic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M352392

- Name: Cerebrolysin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
