Clinical trial NCT07005661: Use of PRP in Open Surgery for Type A Aortic Dissection
Official title: Multicenter, Prospective, Randomized Controlled Trial of Autologous Platelet Rich Plasma (PRP) Use in Open Surgery for Type A Aortic Dissection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Aortic Dissection Type A
Transfusions
Platelet Rich Plasma (PRP)
Organ Protection
Keywords: aortic dissection
transfusions
platelet rich plasma
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: Xiangya Hospital of Central South University
name: Guangzhou First People's Hospital
First posted: 2025-06-05
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Undergoing open surgery for type A aortic dissection (TAAD);
2. Body weight between 60-100 kg; hemoglobin (Hb) \> 120 g/L; platelet count (PLT) ≥ 120 × 10⁹/L;
3. Able to understand the purpose of the study, voluntarily participate, and sign the informed consent form.

Exclusion Criteria:

1. Requires mechanical ventilation before surgery;
2. Age under 18 or over 70 years;
3. Use of anticoagulant or antiplatelet drugs within 7 days before surgery;
4. Cardiogenic shock, cardiac arrest, severe hypotension (requiring two or more vasopressors), or mechanical circulatory support within 24 hours before surgery;
5. Renal failure requiring dialysis;
6. Severe coagulopathy or active bleeding tendency;
7. Known history of heparin-induced thrombocytopenia (HIT);
8. Severe psychiatric illness or other conditions affecting study reliability;
9. Any condition deemed unsuitable by the investigator.

Primary outcomes:
measure: Units of Allogeneic RBC Transfusion Within 24 Hours Perioperatively
timeFrame: From anesthesia induction to 24 hours post-surgery
Secondary outcomes:
measure: Total Volume of Allogeneic Blood Products Used During Hospitalization
timeFrame: From anesthesia induction to hospital discharge
measure: Intraoperative Blood Loss
timeFrame: From the start of anesthesia induction to the end of surgery.
measure: Postoperative 24-Hour Chest Drainage Volume
timeFrame: Within the first 24 hours after surgery
measure: Postoperative Cardiac Dysfunction
timeFrame: 24 hours before surgery and 24 hours after surgery
measure: Postoperative Pulmonary Dysfunction
timeFrame: 24 hours before surgery and 24 hours after surgery
measure: Postoperative Intestinal Dysfunction
timeFrame: 24 hours before surgery and 24 hours after surgery
measure: Postoperative Renal Dysfunction
timeFrame: 24 hours before surgery and 24 hours after surgery
measure: Postoperative Hepatic Dysfunction
timeFrame: 24 hours before surgery and 24 hours after surgery.
measure: Postoperative Neurological Dysfunction
timeFrame: 24 hours before surgery and 24 hours after surgery.
measure: ICU Length of Stay
timeFrame: From postoperative day 0 (the day of surgery) to ICU discharge,up to 30 days.
measure: Total Hospital Length of Stay
timeFrame: From postoperative day 0 (the day of surgery) to hospital discharge, up to 60 days.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology, Beijing Anzhen Hospital
name: Sheng Wang, PhD
role: STUDY_DIRECTOR
References: