Use of PRP in Open Surgery for Type A Aortic Dissection

Capital Medical University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Transfusions; Organ Protection; Aortic Dissection Type A; Platelet Rich Plasma (PRP)

Treatments: Biological: Autologous Platelet Rich Plasma; Procedure: Standard Blood Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07005661

KS2025076

2023ZD0504400 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups

PRP Group

Experimental group

Description:

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.

Treatment:

Procedure: Standard Blood Management

Biological: Autologous Platelet Rich Plasma

Control Group

Active Comparator group

Description:

Participants in this group will not receive autologous PRP infusion during open surgery for Type A aortic dissection and will undergo standard blood management.

Treatment:

Procedure: Standard Blood Management