Aortic Dissection Type APhase 2/3NCT07005661
Use of PRP in Open Surgery for Type A Aortic Dissection
A Phase 2/3 study testing Autologous Platelet Rich Plasma and Standard Blood Management in people with Aortic Dissection Type A and Transfusions, run by Beijing Anzhen Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aortic Dissection Type A, Transfusions, Platelet Rich Plasma (PRP)
- What is being tested?
- Autologous Platelet Rich Plasma and Standard Blood Management
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 31 Oct 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Known history of heparin-induced thrombocytopenia (HIT);
- Severe psychiatric illness or other conditions affecting study reliability;
- Any condition deemed unsuitable by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Pei-rong Lin, PhD contact
About this study
Official title: Multicenter, Prospective, Randomized Controlled Trial of Autologous Platelet Rich Plasma (PRP) Use in Open Surgery for Type A Aortic Dissection
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:
- Does PRP reduce the amount of allogeneic red blood cell transfusions for participants?
- Does PRP administration provide protective effects on organs (heart, liver, lungs, kidneys, brain) in participants?
Read more
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:
- Receive autologous PRP infusion during surgery
- Undergo multiple checkups and tests before and after surgery
- Be recorded for allogeneic red blood cell usage within 24 hours perioperatively and all allogeneic blood products usage during the entire hospitalization
- Be assessed for organ function (heart, liver, lungs, kidneys, brain) and symptom-related outcomes through clinical evaluations
Read the 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.
- Being tested
- Autologous Platelet Rich Plasma, Standard Blood Management
- Keywords
- aortic dissection, transfusions, platelet rich plasma
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet Rich PlasmaBiological
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 .
Standard Blood ManagementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard Blood Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: From anesthesia induction to 24 hours post-surgery
Secondary outcomes (11)
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.
Measured: From anesthesia induction to hospital discharge
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.
Measured: From the start of anesthesia induction to the end of surgery.
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.
Measured: Within the first 24 hours after surgery
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).
Measured: 24 hours before surgery and 24 hours after surgery
Postoperative Pulmonary Dysfunction
Defined as a decreased PaO₂/FiO₂ ratio or elevated neutrophil elastase levels postoperatively, compared to baseline. This outcome aims to assess the potential effect of PRP on pulmonary function preservation.
Measured: 24 hours before surgery and 24 hours after surgery
Postoperative Intestinal Dysfunction
Defined by increased levels of diamine oxidase (DAO) or intestinal fatty acid-binding protein (I-FABP) postoperatively, compared to preoperative baseline. This outcome is intended to explore the potential protective role of PRP on intestinal barrier function.
Measured: 24 hours before surgery and 24 hours after surgery
Postoperative Renal Dysfunction
Defined by increased serum creatinine (Scr), blood urea nitrogen (BUN), neutrophil gelatinase-associated lipocalin (NGAL), or decreased eGFR, relative to preoperative values. This measure aims to evaluate whether PRP use is associated with reduced postoperative renal dysfunction.
Measured: 24 hours before surgery and 24 hours after surgery
Postoperative Hepatic Dysfunction
Defined by elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBil) levels postoperatively, relative to preoperative baseline. This outcome assesses the potential hepatic protective effect of PRP.
Measured: 24 hours before surgery and 24 hours after surgery.
Postoperative Neurological Dysfunction
Defined by increased neuron-specific enolase (NSE) levels after surgery or the occurrence of new-onset stroke confirmed by clinical evaluation or imaging. This outcome aims to determine whether PRP contributes to neuroprotection in the early postoperative period.
Measured: 24 hours before surgery and 24 hours after surgery.
ICU Length of Stay
Duration of ICU stay, measured in days, from postoperative day 0 (the day of surgery) to ICU discharge, up to 30 days. This outcome evaluates whether autologous PRP affects postoperative ICU recovery. The time frame excludes any preoperative ICU stays due to unrelated conditions.As immediate postoperative ICU transfer is standard for type A aortic dissection, this period accurately reflects surgery-related ICU recovery.
Measured: From postoperative day 0 (the day of surgery) to ICU discharge,up to 30 days.
Total Hospital Length of Stay
Total duration of hospitalization, measured in days, from postoperative day 0 (the day of surgery) to hospital discharge, up to 60 days. This outcome assesses the impact of autologous PRP on overall recovery and resource utilization. Hospital length of stay will be calculated starting from postoperative day 0, which is defined as the date of surgery, to exclude variability introduced by hospitalization prior to the surgical diagnosis or intervention.
Measured: From postoperative day 0 (the day of surgery) to hospital discharge, up to 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Dissection Type AStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Xiangya Hospital of Central South University, Guangzhou First People's Hospital
- Responsible party
- Sponsor
- Investigators
- Sheng Wang, PhD, Study director, Department of Anesthesiology, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005661
- Sponsor's protocol ID
- KS2025076
- Other IDs
- 2023ZD0504400
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared materials will include the study protocol and statistical analysis plan (SAP). Data will be available starting 6 months after publication of the primary results and will remain accessible for up to 5 years. 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Randomized Controlled Trial of Autologous Platelet Rich Plasma (PRP) Use in Open Surgery for Type A Aortic Dissection
- ClinicalTrials.gov ID
- NCT07005661
- Acronym / sponsor ID
- KS2025076
- Keywords
- aortic dissection, transfusions, platelet rich plasma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Xiangya Hospital of Central South University, Guangzhou First People's Hospital
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does PRP reduce the amount of allogeneic red blood cell transfusions for participants?
- 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:
- Receive autologous PRP infusion during surgery
- Undergo multiple checkups and tests before and after surgery
- Be recorded for allogeneic red blood cell usage within 24 hours perioperatively and all allogeneic blood products usage during the entire hospitalization
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP Group | Experimental | Biological: Autologous Platelet Rich Plasma, Procedure: Standard Blood ManagementParticipants 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. |
| Control Group | Active comparator | Procedure: Standard Blood ManagementParticipants in this group will not receive autologous PRP infusion during open surgery for Type A aortic dissection and will undergo standard blood management. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet Rich PlasmaPlatelet 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 . | Biological | PRP Group |
| Standard Blood ManagementPerioperative 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. | Procedure or surgery | Control Group, PRP Group |
Primary outcome
Units of Allogeneic RBC Transfusion Within 24 Hours Perioperatively
Time frame: From anesthesia induction to 24 hours post-surgery
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 .
11 secondary outcomes
Total Volume of Allogeneic Blood Products Used During Hospitalization
Time frame: From anesthesia induction to hospital discharge
Intraoperative Blood Loss
Time frame: From the start of anesthesia induction to the end of surgery.
Postoperative 24-Hour Chest Drainage Volume
Time frame: Within the first 24 hours after surgery
Postoperative Cardiac Dysfunction
Time frame: 24 hours before surgery and 24 hours after surgery
Postoperative Pulmonary Dysfunction
Time frame: 24 hours before surgery and 24 hours after surgery
Postoperative Intestinal Dysfunction
Time frame: 24 hours before surgery and 24 hours after surgery
Postoperative Renal Dysfunction
Time frame: 24 hours before surgery and 24 hours after surgery
Postoperative Hepatic Dysfunction
Time frame: 24 hours before surgery and 24 hours after surgery.
Postoperative Neurological Dysfunction
Time frame: 24 hours before surgery and 24 hours after surgery.
ICU Length of Stay
Time frame: From postoperative day 0 (the day of surgery) to ICU discharge,up to 30 days.
Total Hospital Length of Stay
Time frame: From postoperative day 0 (the day of surgery) to hospital discharge, up to 60 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: Yes. Shared materials will include the study protocol and statistical analysis plan (SAP). Data will be available starting 6 months after publication of the primary results and will remain accessible for up to 5 years. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pei-rong Lin, PhD contact
Sheng Wang, PhD study director
Department of Anesthesiology, Beijing Anzhen Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Autologous Platelet Rich Plasma and Standard Blood Management in people with Aortic Dissection Type A and Transfusions, run by Beijing Anzhen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng Wang, PhD (86-13560182353, shengwang_gz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Units of Allogeneic RBC Transfusion Within 24 Hours Perioperatively (time frame: From anesthesia induction to 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.