## Protocol Section
### Identification Module
**NCT ID:** NCT03183479

**Brief Title:** The Effects of Fibrinogen Concentrate Infusion on Blood Loss and Allogeneic Blood Conservation in Scoliosis Surgery

**Official Title:** The Effects of Fibrinogen Concentrate Infusion on Perioperative Blood Loss and Allogeneic Blood Conservation in Patients Undergoing Scoliosis Surgery

#### Organization Study ID Info
**ID:** PUMCH-FC
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2019-08-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-03-02

**Type:** ACTUAL

**Last Update Submit Date:** 2020-02-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-08-31

**Type:** ACTUAL

#### Start Date
**Date:** 2017-06-14

**Type:** ACTUAL

**Status Verified Date:** 2020-02

#### Study First Post Date
**Date:** 2017-06-12
**Type:** ACTUAL
**Study First Submit Date:** 2017-06-05
**Study First Submit QC Date:** 2017-06-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking Union Medical College Hospital

#### Responsible Party

**Investigator Affiliation:** Peking Union Medical College Hospital

**Investigator Full Name:** Weiyun Chen

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Allogeneic blood products transfusions are often necessary to treat perioperative bleeding in patients undergoing complex scoliosis surgeries. A prospective, randomized trial is designed to evaluate if the infusion of fibrinogen concentrate may reduce allogeneic blood transfusion in patients undergoing scoliosis surgery. Eligible patients will be randomly assigned to treatment group (fibrinogen concentrate infusion) and control group (normal saline infusion), and functional fibrinogen will be measured to guide the infusion of fibrinogen concentrate. Perioperative blood loss, intraoperative blood loss, and the amount of perioperative allogeneic blood transfusion will be compared between the two groups to determine the effect of fibrinogen concentrate infusion.

**Detailed Description:** This is a prospective, randomized, double-blinded, placebo controlled trial to evaluate the effects of fibrinogen concentrate infusion on perioperative blood loss and the amount of perioperative allogeneic blood transfusion in patients undergoing scoliosis surgery.

Recently, the inherent risks of blood, along with the continued rise in blood costs, activated the development and use of alternatives to blood transfusion. Fibrinogen concentrate may limit postoperative bleeding and lead to a significant reduction in allogeneic blood products transfusions in cardiac surgery and craniosynostosis surgery. However, the effect of fibrinogen concentrate in scoliosis surgery is still uncertain. Therefore, a prospective, randomized trial is designed to evaluate if the infusion of fibrinogen concentrate may reduce allogeneic blood transfusion in patients undergoing scoliosis surgery.

Patients older than 12y/o with adolescent idiopathic scoliosis planed for elective posterior scoliosis correction surgery will be enrolled for this study after informed consent. Patients will be randomly assigned to a treatment group or a control group. Functional fibrinogen will be measured using TEG 5000 (Haemoscope Corp, IL, USA) at the start of surgery and the results of FLEV and MA will be recorded. After pedicle screw placement, a second functional fibrinogen will be measured and the patients in treatment group will receive fibrinogen concentrate (FIBRORAAS, Shanghai RAAS Blood Products Co, Ltd, Shanghai, China) 30mg kg-1. For safety concern, the maximum fibrinogen concentrate administration for each individual shall not exceed either 2g. Patients in the control group will receive placebo treatment with normal saline. After 15 minutes from fibrinogen concentrate or placebo administration, a third functional fibrinogen measurement will be performed to assess the effect of treatment. The following treatment will be guaranteed by the standard protocol in the presence of ongoing bleeding.

Data includes all the demographics, preoperative conditions, procedure details, intraoperative data, and outcome measurements will be recorded. Additional data including FLEV and MA value, as well as fibrinogen values both preoperatively and at the arrival at wards. The primary endpoint of this study will be the total perioperative blood loss, and secondary endpoints will include: perioperative blood loss per fused level, intraoperative blood loss per fused level, the amount of postoperative drainage, the amount of postoperative drainage per fused level, total units of perioperative allogeneic pRBCs transfused, total volume of FFP transfused, total PLT units transfused. Safety endpoints will include operative mortality and perioperative thromboembolic complications.

### Conditions Module

**Conditions:**

- Scoliosis; Adolescence

- Bleeding

- Surgery

**Keywords:**

- adolescent idiopathic scoliosis

- fibrinogen concentrate

- perioperative blood loss

- transfusion

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** After randomization, the unblinded independent investigator will be in charge of fibrinogen concentrate (drug) or placebo preparation, which will be performed in a laboratory next to the operating room. When the patient meets the inclusion criteria and is enrolled in the study, the functional fibrinogen tests will be done in the same laboratory by the same researcher, and drug or placebo will be prepared in sterile bags with opaque covers afterwards. Fibrinogen concentrate will be diluted in 100mL of sterile water or an equivalent volume of 0.9% saline solution as placebo and will be delivered to the operating room by the investigator. The anesthesiologists, the surgical staff, and the patients will all be blinded.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 102

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The patients in treatment group will receive Fibrinogen Concentrate Human administration.

**Intervention Names:**

- Drug: Fibrinogen Concentrate Human

**Label:** Treatment group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The patients in control group will be administered with normal saline solution as placebo.

**Intervention Names:**

- Drug: Normal saline

**Label:** Control group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment group

**Description:** After start of surgery when all pedicle screws are placed, the patients in treatment group will receive fibrinogen concentrate 30mg kg-1. For safety concern, functional fibrinogen will be measured and the maximum fibrinogen concentrate administration for each individual shall not exceed 2g. Fibrinogen concentrate will be diluted in 100mL of sterile water and then be administered to patients.

**Name:** Fibrinogen Concentrate Human

**Other Names:**

- FIBRORAAS

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** 100mL normal saline will be administered to patients in control group as placebo

**Name:** Normal saline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** the total amount of intraoperative and postoperative blood loss

**Measure:** Perioperative blood loss

**Time Frame:** hospital stay up to 30 days

#### Secondary Outcomes

**Description:** amount of intraoperative and postoperative blood loss divided by the number of surgical fused levels

**Measure:** Perioperative blood loss per fused level

**Time Frame:** hospital stay up to 30 days

**Description:** the amount of intraoperative blood loss

**Measure:** Intraoperative blood loss

**Time Frame:** From the time of skin incision until wound closure, assessed up to 12 hours

**Description:** amount of intraoperative blood loss divided by the number of surgical fused levels

**Measure:** Intraoperative blood loss per fused level

**Time Frame:** From the time of skin incision until wound closure, assessed up to 12 hour

**Description:** the amount of postoperative drainage

**Measure:** Postoperative drainage

**Time Frame:** hospital stay up to 30 days

**Description:** amount of postoperative drainage divided by the number of surgical fused levels

**Measure:** Postoperative drainage per fused level

**Time Frame:** hospital stay up to 30 days

**Description:** total units of RBC transfused perioperatively

**Measure:** Perioperative allogeneic red blood cell (RBC) transfusion

**Time Frame:** hospital stay up to 30 days

**Description:** total volume of plasma transfused perioperatively

**Measure:** Perioperative plasma transfusion

**Time Frame:** hospital stay up to 30 days

**Description:** total units of platelets transfused perioperatively

**Measure:** Perioperative platelets transfusion

**Time Frame:** hospital stay up to 30 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* patients diagnosed as adolescent idiopathic scoliosis
* planed for elective posterior scoliosis correction surgery at Peking Union Medical College Hospital

Exclusion Criteria:

* preoperative anemia
* preoperative congenital or acquired coagulopathy
* ongoing anticoagulation therapy or drug intake that could cause bleeding
* clinical signs or diagnosis of acute thromboembolism
* emergency surgery
* redo surgery

**Maximum Age:** 18 Years

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** Peking Union Medical College Hospital

**State:** Beijing

**Zip:** 100730

#### Overall Officials

**Official 1:**

**Affiliation:** Peking Union Medical College Hospital

**Name:** Weiyun Chen, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Data would only be shared with IRB approved collaborators.

**Description:** Coded data is anticipated to be shared with potential collaborators.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** Anticipated that data from the study will become available within 5 years after publication of main data.

### References Module

#### References

**Citation:** Chen W, Shen J, Zhang Y, Hu A, Liang J, Ma L, Yu X, Huang Y. A randomised controlled trial of fibrinogen concentrate during scoliosis surgery. Anaesthesia. 2020 Nov;75(11):1476-1481. doi: 10.1111/anae.15124. Epub 2020 Jun 4.

**PMID:** 32500569

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013121

- Term: Spinal Curvatures

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Blood Loss

- ID: M15417

- Name: Scoliosis

- Relevance: HIGH

- As Found: Scoliosis

- ID: M15918

- Name: Spinal Curvatures

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012600

- Term: Scoliosis

- ID: D000006470

- Term: Hemorrhage

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
