## Protocol Section
### Identification Module
**NCT ID:** NCT06437990

**Brief Title:** Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Surgery

**Official Title:** Pilot Study of Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Injured Patients With Insufficient Flow of Donor Artery

#### Organization Study ID Info
**ID:** 652/2556(EC4)
#### Organization
**Class:** OTHER
**Full Name:** Siriraj Hospital
### Status Module
#### Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-04-30

**Type:** ACTUAL

#### Start Date
**Date:** 2015-11-19

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Siriraj Hospital

#### Responsible Party

**Investigator Affiliation:** Siriraj Hospital

**Investigator Full Name:** Panai Laohaprasitiporn, MD

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Free functional muscle transfer (FFMT) using the gracilis muscle as a donor muscle has become a standard treatment for reconstructing late-onset brachial plexus injuries. Successful implementation of this procedure relies on the availability of functional donor vessels in the injured limb to supply the muscle flap. However, some brachial plexus injuries are accompanied by subclavian or axillary artery injuries, which compromise the viability of the muscle flap due to insufficient vascular supply. To address this, arteriovenous (AV) loop grafts have been employed to extend donor vessels to the flap and have been utilized in various body regions, including the upper extremity. Despite their widespread use, AV loop grafts have not been previously utilized in FFMT for late-onset brachial plexus injuries with concurrent subclavian or axillary artery injuries. This study aimed to assess the feasibility of this surgical approach and report the long-term outcomes of the procedure.

### Conditions Module

**Conditions:**

- Brachial Plexus Injury

**Keywords:**

- brachial plexus injury

- brachial plexus palsy

- free functional muscle transfer

- arteriovenous loop graft

- subclavian artery injury

- axillary artery injury

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Late-onset brachial plexus injury patient with concomitant subclavian or axillary artery injury

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** A saphenous vein graft was used to create an arteriovenous loop from the common carotid artery to the external jugular vein, providing vascular supply for a free functional gracilis muscle flap in patients with late-onset brachial plexus injury.

**Intervention Names:**

- Procedure: Arteriovenous loop graft

**Label:** Arteriovenous loop graft

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arteriovenous loop graft

**Description:** Using saphenous vein graft to create an arteriovenous loop from the common carotid artery to the external jugular vein, providing vascular supply for a free functional gracilis muscle flap in patients with late-onset brachial plexus injury with concomitant subclavian or axillary artery injury.

**Name:** Arteriovenous loop graft

**Other Names:**

- AV loop graft

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Survival of the flap after the surgery

**Measure:** Viability of the flap

**Time Frame:** 1 month

#### Secondary Outcomes

**Description:** Medical Research Council (MRC) grading for motor power assessment

**Measure:** Motor power

**Time Frame:** 12 months, 18 months

**Description:** Bleeding, infection, blood transfusion, stroke, embolism, thrombosis

**Measure:** Complications

**Time Frame:** 1 month

**Description:** Total operative time including flap revision surgery or other related complications

**Measure:** Operative time

**Time Frame:** 1 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age equal or more than 20 years old
* Patients with brachial plexus injury with depletion of blood flow to the injured limb which confirmed by abnormal computed tomography arteriogram

Exclusion Criteria:

* Patients who had sufficient thoraco-acromial or thoraco-dorsal artery blood flow for standard free functional muscle transfer operation without the need of an AV loop graft

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bangkoknoi

**Country:** Thailand

**Facility:** Faculty of Medicine Siriraj Hospital, Mahidol University

**State:** Bangkok

**Zip:** 10700

#### Overall Officials

**Official 1:**

**Affiliation:** Siriraj Hospital

**Name:** Panai Laohaprasitiporn, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
