Use of PRP in Open Surgery for Type A Aortic Dissection

NCT07005661 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: KS20250762023ZD0504400
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Keywords

aortic dissection; transfusions; platelet rich plasma

Outcome Measures

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 .

  From anesthesia induction to 24 hours post-surgery

Secondary Outcomes (11)

• Total Volume of Allogeneic Blood Products Used During Hospitalization

  From anesthesia induction to hospital discharge

• Intraoperative Blood Loss

  From the start of anesthesia induction to the end of surgery.

• Postoperative 24-Hour Chest Drainage Volume

  Within the first 24 hours after surgery

• Postoperative Cardiac Dysfunction

  24 hours before surgery and 24 hours after surgery

• Postoperative Pulmonary Dysfunction

  24 hours before surgery and 24 hours after surgery

Study Arms (2)

PRP Group

EXPERIMENTAL

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.

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

Control Group

ACTIVE COMPARATOR

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

Procedure: Standard Blood Management

Interventions

Autologous Platelet Rich Plasma BIOLOGICAL

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 .

PRP Group

Standard Blood Management PROCEDURE

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.

Control Group; PRP Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Guangdong Provincial People's Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• Guangzhou First People's Hospital: collaborator

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Sheng Wang, PhD

  Department of Anesthesiology, Beijing Anzhen Hospital

  STUDY DIRECTOR

Central Study Contacts

Sheng Wang, PhD

CONTACT

86-13560182353; shengwang_gz@163.com

Pei-rong Lin, PhD

CONTACT

lalunalin@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 5, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available starting 6 months after publication of the primary results and will remain accessible for up to 5 years.
• Access Criteria: Access will be granted to researchers with scientifically valid proposals and a signed data use agreement. Requests should be directed to the principal investigator via the sponsor institution.