C.Surgical Procedure; CardiacNCT02513862
Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery
A study testing Autologous Platelet-Rich Plasma Harvest Technique in people with C.Surgical Procedure; Cardiac, run by Hongwen Ji at 1 site in China.
Trial summary
The purpose of this study is to determine whether autologous platelet rich plasma (APRP)is effective in reducing allogeneic blood transfusions during aortic surgery using deep hypothermic circulatory arrest. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- C.Surgical Procedure; Cardiac
- What is being tested?
- Autologous Platelet-Rich Plasma Harvest Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- patients undergoing elective or emergency aortic surgery using deep hypothermic circulatory arrest、
- preoperative platelet counts>150000000000/L、
- preoperative hematocrit>33%、
- without recent anticoagulants less than 5 days
Who cannot join
- preoperative coagulation disorder
- severe renal and liver dysfunction
- preoperative hemodynamic instability
Trial locations and contacts
1 site in 1 country.
China1 site
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037
About this study
Official title: Prospective Randomized Trial of Autologous Platelet Rich Plasma in Reducing Allogeneic Transfusions During Aortic Surgery Under Deep Hypothermic Circulatory Arrest
The purpose of this study is to determine whether autologous platelet rich plasma (APRP)is effective in reducing allogeneic blood transfusions during aortic surgery using deep hypothermic circulatory arrest.
- Conditions
- C.Surgical Procedure; Cardiac
- Being tested
- Autologous Platelet-Rich Plasma Harvest Technique
- Keywords
- autologous platelet rich plasma, deep hypothermic circulatory arrest, transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-Rich Plasma Harvest TechniqueDevice
Also called neutralizing heparin with protamine
15 to 20 mL/kg of whole blood is collected before the administration of heparin from a large-bore central venous access,and is separated into red blood cells component and autologous platelet-rich plasma component by an autologous transfusion system(Sorin Group Electa Essential; Sorin Group Italia, Milan, Italy).
| Study group | Role | What they receive |
|---|---|---|
| APRP group | Experimental | APRP group is performed autologous platelet-rich plasma harvest technique before administration of heparin to the patient,the red blood cell(RBC) component is retransfused to the patient when the RBC transfusion protocol is reached,and the autologous platelet-rich plasma is transfused to the patient immediately after heparin is neutralized with protamine. Receives: Device: Autologous Platelet-Rich Plasma Harvest Technique |
| control group | No intervention | APRP group receive no autologous platelet-rich plasma harvest technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
total perioperative allogenic transfusions of platelet and fresh frozen plasma
Measured: on the 7th day postoperatively
Secondary outcomes (2)
postoperative blood loss
Measured: on the 7th day postoperatively
rate of reexploration for bleeding
Measured: on the 7th day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Surgical Procedure; CardiacStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hongwen Ji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongwen Ji, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Hongwen Ji, MD, Study chair, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMCYongyuan Wang, Principal investigator, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513862
- Sponsor's protocol ID
- 2014-zx011
- Status last verified
- Nov 2016
- First submitted
- 23 Jun 2015
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Autologous Platelet Rich Plasma in Reducing Allogeneic Transfusions During Aortic Surgery Under Deep Hypothermic Circulatory Arrest
- ClinicalTrials.gov ID
- NCT02513862
- Acronym / sponsor ID
- 2014-zx011
- Conditions
- C.Surgical Procedure; Cardiac
- Keywords
- autologous platelet rich plasma, deep hypothermic circulatory arrest, transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hongwen JiUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Aug 2015 (estimated)
- 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 purpose of this study is to determine whether autologous platelet rich plasma (APRP)is effective in reducing allogeneic blood transfusions during aortic surgery using deep hypothermic circulatory arrest.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APRP group | Experimental | Device: Autologous Platelet-Rich Plasma Harvest TechniqueAPRP group is performed autologous platelet-rich plasma harvest technique before administration of heparin to the patient,the red blood cell(RBC) component is retransfused to the patient when the RBC transfusion protocol is reached,and the autologous platelet-rich plasma is transfused to the patient immediately after heparin is neutralized with protamine. |
| control group | No intervention | –APRP group receive no autologous platelet-rich plasma harvest technique. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing elective or emergency aortic surgery using deep hypothermic circulatory arrest、
- preoperative platelet counts>150000000000/L、
- preoperative hematocrit>33%、
- without recent anticoagulants less than 5 days
Key exclusion criteria (3 listed)
- preoperative coagulation disorder
- severe renal and liver dysfunction
- preoperative hemodynamic instability
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 Plasma Harvest TechniqueAlso: neutralizing heparin with protamine15 to 20 mL/kg of whole blood is collected before the administration of heparin from a large-bore central venous access,and is separated into red blood cells component and autologous platelet-rich plasma component by an autologous transfusion system(Sorin Group Electa Essential; Sorin Group Italia, Milan, Italy). | Device | APRP group |
Primary outcome
total perioperative allogenic transfusions of platelet and fresh frozen plasma
Time frame: on the 7th day postoperatively
2 secondary outcomes
postoperative blood loss
Time frame: on the 7th day postoperatively
rate of reexploration for bleeding
Time frame: on the 7th day postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
Related trials for C.Surgical Procedure; Cardiac
Active, not recruiting
Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
C.Surgical Procedure; Cardiac
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. This study is not recruiting at the moment.
Hongwen Ji, MD study chair
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Yongyuan Wang principal investigator
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet-Rich Plasma Harvest Technique in people with C.Surgical Procedure; Cardiac, run by Hongwen Ji at 1 site in China.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total perioperative allogenic transfusions of platelet and fresh frozen plasma (time frame: on the 7th day postoperatively). 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 16 Nov 2016.