Autologous Blood TransfusionNCT02572440
Autologous Platelet-rich Plasma (aPRP) for Complex Aortic Arch Surgerymacrovascular Operation
A study testing Sorin XTRA/Sorin Group, in people with Autologous Blood Transfusion, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Perioperative blood loss continues to be a serious problem in complex aortic arch surgery using deep hypothermic circulatory arrest (DHCA). Major blood loss causes increased morbidity and mortality [1]. These patients often require transfusion of allogeneic blood products. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autologous Blood Transfusion
- What is being tested?
- Sorin XTRA/Sorin Group,
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Oct 2014to Jun 2015
- Phase
- Expanded access
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- adults older than 18 years old, type A aortic dissections patients undergoing frozen elephant trunk with total arch replacement (Bentall plus Sun's surgery) with DHCA.
Who cannot join
- patients with hepatitis B virus infection, coagulation disorder, anemia (HBG<11mg/dl), stopping anticoagulants less than 7 days and end-stage renal disease dependent on hemodialysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University
Perioperative blood loss continues to be a serious problem in complex aortic arch surgery using deep hypothermic circulatory arrest (DHCA). Major blood loss causes increased morbidity and mortality [1]. These patients often require transfusion of allogeneic blood products. It has been estimated shortages of blood supply in China will worsen [2]. Clinicians have made significant progress to decrease the quality of allogenic blood transfusion.
Increasing postoperative hemorrhage risk of aortic arch patients undergoing DHCA may be related to CPB induced hemostatic defect, the use of the CPB is likely to contribute to coagulation factor lost and platelet dysfunction [3, 4]. We are aware of the potential benefit of aPRP, withdrawal of aPRP immediately before initiating CPB appears to be a promising approach because it avoids CPB-related platelet damage and limits post-CPB blood loss. So we adopted and used aPRP as a blood conservation technique to reduce blood transfusion in aortic arch surgery with DHCA. Autologous red blood cells were infused to maintain a HGB level above 100 g/L after heparin neutralizing activity. And aPRPs were transfused after heparin neutralizing activity as no active bleeding was observed. Our goal was to determine the effect between aPRP and homologous transfusion on perioperative bleeding during complex aortic arch surgery using DHCA.
Read the detailed description
- Patient selection 42 type A aortic dissections patients were asked to participate in a prospective, randomized trial comparing aPRP technique with regular blood conservation. 6 patients were excluded The patients were randomized into two groups: regular blood conservation group(n=18) and aPRP group(n=18). Patients gave informed consent, and ethical permission was approved by the Human Ethics Committee of Beijing Anzhen Hospital. The grouping situation is blinded to the surgeon, perfusionist and statistician.
- Anesthesia and monitoring method All patients were monitored according to the American Society of Anesthesia guidelines and received standard general anesthesia. A post-operative analgesic pump was used until four days after surgery. The same group of surgeons performed all operations. Extracorporeal circulation used DHCA and axillary arterial anterograde cerebral perfusion. In addition, the same group of physicians managed extracorporeal circulation.
- Autologous Platelet-Rich Plasma Harvest Technique In the treatment group, shortly after administration of general anesthesia, blood was collected via central venous catheter 60 ml per minute (that was proven to be safe) and approximately 15-20 mL/kg of whole blood was collected. The harvested blood was then centrifuged at 2400 rpm to separate the red blood cells (RBC) from the autologous platelet rich plasma (aPRP). The separated blood component was processed by acid sodium citrate glucose solution (AcD-A) for anti-coagulation. No systemic heparin was administered at this time. The aPRP component was then stored at 20℃ - 24℃. When the blood withdrawal was proceeding, lactated ringer's solution and succinylated gelatin were used via the peripheral vein to dilate circulating capacity and maintain hemodynamic stability. A vasoactive drug was used if necessary. The systematic heparinization began after blood collection had completed. General blood salvage was performed during surgery and transfused according to the patient's actual intraoperative needs. The mean quantity of whole blood collected for Autologous Platelet-Rich Plasma Harvest was 1037 ± 286 mL. The control group was only subjected to general intraoperative blood conservation using red blood cell salvage and allogenic blood transfusion.
- Transfusion Practice Autologous red blood cells were infused to maintain the HGB level above 100 g/L. While on CPB, the hemoglobin (HGB) level was maintained between 70 g/L to 90 g/L. Salvaged blood was also used following CPB. FFP, platelets, and aPRP were transfused after protamine reversed heparinization, since no active bleeding was observed. Therapeutic transfusion triggers were: INR TEG-R>11 min for FFP administration; TEG-a <63 degrees for human fibrinogen; and TEG-MA <52 mm for aphaeresis platelets
- Conditions
- Autologous Blood Transfusion
- Being tested
- Sorin XTRA/Sorin Group,
- Keywords
- Aortic arch surgery; Blood conservation; aPRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorin XTRA/Sorin Group,Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Blood TransfusionStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Liyun, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572440
- Sponsor's protocol ID
- Z13110700213134
- Status last verified
- Oct 2015
- First submitted
- 7 Oct 2015
- Last updated
- 9 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University
- ClinicalTrials.gov ID
- NCT02572440
- Acronym / sponsor ID
- Z13110700213134
- Conditions
- Autologous Blood Transfusion
- Keywords
- Aortic arch surgery; Blood conservation; aPRP
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- First posted
- 9 Oct 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.
Perioperative blood loss continues to be a serious problem in complex aortic arch surgery using deep hypothermic circulatory arrest (DHCA). Major blood loss causes increased morbidity and mortality [1]. These patients often require transfusion of allogeneic blood products. It has been estimated shortages of blood supply in China will worsen [2]. Clinicians have made significant progress to decrease the quality of allogenic blood transfusion.
Increasing postoperative hemorrhage risk of aortic arch patients undergoing DHCA may be related to CPB induced hemostatic defect, the use of the CPB is likely to contribute to coagulation factor lost and platelet dysfunction [3, 4]. We are aware of the potential benefit of aPRP, withdrawal of aPRP immediately before initiating CPB appears to be a promising approach because it avoids CPB-related platelet damage and limits post-CPB blood loss. So we adopted and used aPRP as a blood conservation technique to reduce blood transfusion in aortic arch surgery with DHCA. Autologous red blood cells were infused to maintain a HGB level above 100 g/L after heparin neutralizing activity. And aPRPs were transfused after heparin neutralizing activity as no active bleeding was observed. Our goal was to determine the effect between aPRP and homologous transfusion on perioperative bleeding during complex aortic arch surgery using DHCA.
Detailed description
- Patient selection 42 type A aortic dissections patients were asked to participate in a prospective, randomized trial comparing aPRP technique with regular blood conservation. 6 patients were excluded The patients were randomized into two groups: regular blood conservation group(n=18) and aPRP group(n=18). Patients gave informed consent, and ethical permission was approved by the Human Ethics Committee of Beijing Anzhen Hospital. The grouping situation is blinded to the surgeon, perfusionist and statistician.
- Anesthesia and monitoring method All patients were monitored according to the American Society of Anesthesia guidelines and received standard general anesthesia. A post-operative analgesic pump was used until four days after surgery. The same group of surgeons performed all operations. Extracorporeal circulation used DHCA and axillary arterial anterograde cerebral perfusion. In addition, the same group of physicians managed extracorporeal circulation.
- Autologous Platelet-Rich Plasma Harvest Technique In the treatment group, shortly after administration of general anesthesia, blood was collected via central venous catheter 60 ml per minute (that was proven to be safe) and approximately 15-20 mL/kg of whole blood was collected. The harvested blood was then centrifuged at 2400 rpm to separate the red blood cells (RBC) from the autologous platelet rich plasma (aPRP). The separated blood component was processed by acid sodium citrate glucose solution (AcD-A) for anti-coagulation. No systemic heparin was administered at this time. The aPRP component was then stored at 20℃ - 24℃. When the blood withdrawal was proceeding, lactated ringer's solution and succinylated gelatin were used via the peripheral vein to dilate circulating capacity and maintain hemodynamic stability. A vasoactive drug was used if necessary. The systematic heparinization began after blood collection had completed. General blood salvage was performed during surgery and transfused according to the patient's actual intraoperative needs. The mean quantity of whole blood collected for Autologous Platelet-Rich Plasma Harvest was 1037 ± 286 mL. The control group was only subjected to general intraoperative blood conservation using red blood cell salvage and allogenic blood transfusion.
- Transfusion Practice Autologous red blood cells were infused to maintain the HGB level above 100 g/L. While on CPB, the hemoglobin (HGB) level was maintained between 70 g/L to 90 g/L. Salvaged blood was also used following CPB. FFP, platelets, and aPRP were transfused after protamine reversed heparinization, since no active bleeding was observed. Therapeutic transfusion triggers were: INR TEG-R>11 min for FFP administration; TEG-a <63 degrees for human fibrinogen; and TEG-MA <52 mm for aphaeresis platelets
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults older than 18 years old, type A aortic dissections patients undergoing frozen elephant trunk with total arch replacement (Bentall plus Sun's surgery) with DHCA.
Key exclusion criteria (1 listed)
- patients with hepatitis B virus infection, coagulation disorder, anemia (HBG<11mg/dl), stopping anticoagulants less than 7 days and end-stage renal disease dependent on hemodialysis.
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 |
|---|---|---|
| Sorin XTRA/Sorin Group, | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sorin XTRA/Sorin Group, in people with Autologous Blood Transfusion, run by Beijing Anzhen Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Oct 2015. 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?
Results are not available in the source record.
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.
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 9 Oct 2015.