NCT07005661

Use of PRP in Open Surgery for Type A Aortic Dissection

Multicenter, Prospective, Randomized Controlled Trial of Autologous Platelet Rich Plasma (PRP) Use in Open Surgery for Type A Aortic Dissection

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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: 1. Does PRP reduce the amount of allogeneic red blood cell transfusions for participants? 2. Does PRP administration provide protective effects on organs (heart, liver, lungs, kidneys, brain) in participants? 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: 1. Receive autologous PRP infusion during surgery 2. Undergo multiple checkups and tests before and after surgery 3. Be recorded for allogeneic red blood cell usage within 24 hours perioperatively and all allogeneic blood products usage during the entire hospitalization 4. Be assessed for organ function (heart, liver, lungs, kidneys, brain) and symptom-related outcomes through clinical evaluations

Detailed description

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.

Conditions

• Aortic Dissection Type A
• Transfusions
• Platelet Rich Plasma (PRP)
• Organ Protection

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Platelet Rich Plasma	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 .
PROCEDURE	Standard Blood Management	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.

Timeline

• Start date: 2025-06-30
• Primary completion: 2028-01-31
• Completion: 2028-10-31
• First posted: 2025-06-05
• Last updated: 2025-06-05