Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023ZD0504400 | Other Grant/Funding Number | the Ministry of Science and Technology of China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Guangdong Provincial People's Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Guangzhou First People's Hospital | OTHER |
Not provided
Not provided
Not provided
The goal of this clinical trial is to determine if autologous platelet rich plasma (PRP) can reduce the need for blood transfusions in patients undergoing open surgery for Type A aortic dissection. It will also evaluate the potential organ-protective effects of autologous PRP. The main questions it aims to answer are:
Researchers will compare the administration of autologous PRP with no PRP infusion to assess whether PRP can reduce blood transfusions and provide organ-protective effects in patients undergoing open surgery for Type A aortic dissection.
Participants will:
This multicenter, prospective, randomized, double-blind clinical trial aims to evaluate the efficacy of autologous platelet rich plasma (PRP) in improving outcomes for patients undergoing open surgery for Type A aortic dissection. The study primarily focuses on PRP's ability to reduce transfusion while also exploring its potential role in organ protection. Autologous PRP is prepared from the patient's own blood and administered intraoperatively, integrated with standard blood management practices .
The trial employs a two-arm design, with participants randomly assigned to either the PRP group or the control group. The intervention aligns seamlessly with existing surgical protocols, ensuring feasibility across multiple centers. Data collection emphasizes real-time monitoring and standardized procedures to maintain consistency. The double-blind approach, where participants, investigators, and outcome assessors are masked, minimizes bias and enhances the reliability of results.
The rationale for this trial stems from the high morbidity associated with Type A aortic dissection surgery, particularly due to excessive bleeding and organ injury. Preliminary evidence suggests that PRP may enhance hemostasis and tissue repair, offering a novel therapeutic avenue for this high-risk procedure. This study seeks to provide robust evidence on PRP's clinical utility, potentially shaping future surgical management strategies.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP Group | Experimental | Participants in this group will undergo standard blood management and will receive autologous platelet rich plasma (PRP) infusion during open surgery for Type A aortic dissection. |
|
| Control Group | Active Comparator | Participants in this group will not receive autologous PRP infusion during open surgery for Type A aortic dissection and will undergo standard blood management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Platelet Rich Plasma | Biological | Platelet apheresis was initiated immediately after central venous catheterization and completed before systemic heparinization using the XTRA system (LivaNova, UK). Whole blood was collected at ~60 mL/min via central venous access, ~300 mL per cycle, anticoagulated with sodium citrate. After separation, autologous platelet rich plasma and concentrated RBCs were obtained. The process was repeated for 4-6 cycles, collecting plasma equal to ~20-30% of estimated blood volume (Nadler formula). Crystalloids or colloids were infused during the procedure, and RBCs from the prior cycle were reinfused to maintain hemodynamic stability. Platelet rich plasma was stored in collection bags, agitated at room temperature, and reinfused after heparin neutralization . |
| Measure | Description | Time Frame |
|---|---|---|
| Units of Allogeneic RBC Transfusion Within 24 Hours Perioperatively | The total number of allogeneic RBC units transfused from the start of anesthesia induction through 24 hours post-surgery for Type A aortic dissection, to evaluate the effect of autologous PRP on transfusion . | From anesthesia induction to 24 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Volume of Allogeneic Blood Products Used During Hospitalization | The cumulative volume of allogeneic blood products (including red blood cells, plasma, platelets, and cryoprecipitate) used throughout the entire hospitalization period for Type A aortic dissection surgery, to assess the broader impact of autologous PRP on transfusion. | From anesthesia induction to hospital discharge |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Wang, PhD | Contact | 86-13560182353 | shengwang_gz@163.com | |
| Pei-rong Lin, PhD | Contact | lalunalin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Sheng Wang, PhD | Department of Anesthesiology, Beijing Anzhen Hospital | Study Director |
Not provided
Shared materials will include the study protocol and statistical analysis plan (SAP). Data will be available starting 6 months after publication of the primary results and will remain accessible for up to 5 years. Access will be granted to researchers with scientifically valid proposals and a signed data use agreement. Requests should be directed to the principal investigator via the sponsor institution.
Data will be available starting 6 months after publication of the primary results and will remain accessible for up to 5 years.
Access will be granted to researchers with scientifically valid proposals and a signed data use agreement. Requests should be directed to the principal investigator via the sponsor institution.
Not provided
Not provided
| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard Blood Management | Procedure | Perioperative transfusion is based on intraoperative hemodynamics and internal environment. Routine blood salvage is performed, with tranexamic acid given throughout (30 mg/kg IV loading dose, 16 mg/kg/h IV maintenance, 2 mg/kg for CPB priming). CPB is primed with 1500 ml using an integrated oxygenator, without ultrafiltration emphasis. At surgery's end, heparin-protamine neutralization is guided by a decision-making system, with point-of-care coagulation monitoring to selectively transfuse blood products based on coagulation abnormalities. |
|
| Intraoperative Blood Loss | Estimated intraoperative blood loss, recorded based on anesthesia records and the surgeon's assessment. This outcome is used to evaluate whether autologous PRP contributes to reduced intraoperative bleeding. | From the start of anesthesia induction to the end of surgery. |
| Postoperative 24-Hour Chest Drainage Volume | The total chest drainage volume (mL) within 24 hours after surgery, based on actual measured values. This outcome is used to assess postoperative bleeding and evaluate the potential hemostatic effect of PRP. | Within the first 24 hours after surgery |
| Postoperative Cardiac Dysfunction | Defined by elevated cardiac troponin T (cTnT), new ischemic changes on ECG, or reduced ejection fraction on transthoracic echocardiography, compared to preoperative values. This outcome aims to evaluate the potential cardioprotective effect of autologous platelet rich plasma (PRP). | 24 hours before surgery and 24 hours after surgery |
| Postoperative Pulmonary Dysfunction | Defined as a decreased PaO₂/FiO₂ ratio or elevated neutrophil elastase levels postoperatively, compared to baseline. This outcome aims to assess the potential effect of PRP on pulmonary function preservation. | 24 hours before surgery and 24 hours after surgery |
| Postoperative Intestinal Dysfunction | Defined by increased levels of diamine oxidase (DAO) or intestinal fatty acid-binding protein (I-FABP) postoperatively, compared to preoperative baseline. This outcome is intended to explore the potential protective role of PRP on intestinal barrier function. | 24 hours before surgery and 24 hours after surgery |
| Postoperative Renal Dysfunction | Defined by increased serum creatinine (Scr), blood urea nitrogen (BUN), neutrophil gelatinase-associated lipocalin (NGAL), or decreased eGFR, relative to preoperative values. This measure aims to evaluate whether PRP use is associated with reduced postoperative renal dysfunction. | 24 hours before surgery and 24 hours after surgery |
| Postoperative Hepatic Dysfunction | Defined by elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBil) levels postoperatively, relative to preoperative baseline. This outcome assesses the potential hepatic protective effect of PRP. | 24 hours before surgery and 24 hours after surgery. |
| Postoperative Neurological Dysfunction | Defined by increased neuron-specific enolase (NSE) levels after surgery or the occurrence of new-onset stroke confirmed by clinical evaluation or imaging. This outcome aims to determine whether PRP contributes to neuroprotection in the early postoperative period. | 24 hours before surgery and 24 hours after surgery. |
| ICU Length of Stay | Duration of ICU stay, measured in days, from postoperative day 0 (the day of surgery) to ICU discharge, up to 30 days. This outcome evaluates whether autologous PRP affects postoperative ICU recovery. The time frame excludes any preoperative ICU stays due to unrelated conditions.As immediate postoperative ICU transfer is standard for type A aortic dissection, this period accurately reflects surgery-related ICU recovery. | From postoperative day 0 (the day of surgery) to ICU discharge,up to 30 days. |
| Total Hospital Length of Stay | Total duration of hospitalization, measured in days, from postoperative day 0 (the day of surgery) to hospital discharge, up to 60 days. This outcome assesses the impact of autologous PRP on overall recovery and resource utilization. Hospital length of stay will be calculated starting from postoperative day 0, which is defined as the date of surgery, to exclude variability introduced by hospitalization prior to the surgical diagnosis or intervention. | From postoperative day 0 (the day of surgery) to hospital discharge, up to 60 days. |
| D000094683 |
| Acute Aortic Syndrome |
| D001018 | Aortic Diseases |