Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2026-01-10 @ 3:11 PM
Study NCT ID:
NCT07005661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-05
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of PRP in Open Surgery for Type A Aortic Dissection
Sponsor:
Beijing Anzhen Hospital
Organization:
Study Overview
Official Title:
Multicenter, Prospective, Randomized Controlled Trial of Autologous Platelet Rich Plasma (PRP) Use in Open Surgery for Type A Aortic Dissection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023ZD0504400 | OTHER_GRANT | the Ministry of Science and Technology of China | View |