Use of PRP in Open Surgery for Type A Aortic Dissection

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Биопрепарат 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). Cry
• Процедура 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 bloo

Первичные конечные точки

• Units of Allogeneic RBC Transfusion Within 24 Hours Perioperatively [Срок оценки: From anesthesia induction to 24 hours post-surgery]

Вторичные конечные точки (11)

• Total Volume of Allogeneic Blood Products Used During Hospitalization [Срок оценки: From anesthesia induction to hospital discharge]
• Intraoperative Blood Loss [Срок оценки: From the start of anesthesia induction to the end of surgery.]
• Postoperative 24-Hour Chest Drainage Volume [Срок оценки: Within the first 24 hours after surgery]
• Postoperative Cardiac Dysfunction [Срок оценки: 24 hours before surgery and 24 hours after surgery]
• Postoperative Pulmonary Dysfunction [Срок оценки: 24 hours before surgery and 24 hours after surgery]
• Postoperative Intestinal Dysfunction [Срок оценки: 24 hours before surgery and 24 hours after surgery]
• Postoperative Renal Dysfunction [Срок оценки: 24 hours before surgery and 24 hours after surgery]
• Postoperative Hepatic Dysfunction [Срок оценки: 24 hours before surgery and 24 hours after surgery.]
• Postoperative Neurological Dysfunction [Срок оценки: 24 hours before surgery and 24 hours after surgery.]
• ICU Length of Stay [Срок оценки: From postoperative day 0 (the day of surgery) to ICU discharge,up to 30 days.]
• Total Hospital Length of Stay [Срок оценки: From postoperative day 0 (the day of surgery) to hospital discharge, up to 60 days.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;
• Renal failure requiring dialysis;
• Severe coagulopathy or active bleeding tendency;
• Known history of heparin-induced thrombocytopenia (HIT);
• Severe psychiatric illness or other conditions affecting study reliability;
• Any condition deemed unsuitable by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07005661 · KS2025076 · 2023ZD0504400

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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