Use of PRP in Open Surgery for Type A Aortic Dissection
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Anzhen Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undergoing open surgery for type A aortic dissection (TAAD);
Body weight between 60-100 kg; hemoglobin (Hb) > 120 g/L; platelet count (PLT) ≥ 120 × 10⁹/L;
Able to understand the purpose of the study, voluntarily participate, and sign the informed consent form.
Disqualifiers
Requires mechanical ventilation before surgery;
Age under 18 or over 70 years;
Use of anticoagulant or antiplatelet drugs within 7 days before surgery;
Cardiogenic shock, cardiac arrest, severe hypotension (requiring two or more vasopressors), or mechanical circulatory support within 24 hours before surgery;
Trial design
Design model
Parallel
Treatments tested in this trial
Autologous Platelet Rich Plasma
Biological/VaccinePlatelet 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 .
Standard Blood Management
Procedure/SurgeryPerioperative 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: PRP GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 .
Time frame
From anesthesia induction to 24 hours post-surgerySecondary outcomes
1
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.
Time frame
From anesthesia induction to hospital discharge2
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.
Time frame
From the start of anesthesia induction to the end of surgery.3
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.
Time frame
Within the first 24 hours after surgery4
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).
Time frame
24 hours before surgery and 24 hours after surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Anzhen Hospital
Lead sponsor
Guangdong Provincial People's Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Guangzhou First People's Hospital
Collaborator
Source ClinicalTrials.gov
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