Cardiovascular SurgeryNCT05966012
Tranexamic Acid Dose and Confusion After Cardiac Surgery
An observational study of Cardiovascular Surgery, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Delirium is one of the most common complications after cardiac surgery and occurs with an incidence of 3 - 70%. Both predisposing factors (age, diabetes, severity of cardiac disease, atrial fibrillation) and precipitating factors (type of surgery, duration of cardiopulmonary bypass (CPB) and surgery, ventilator time… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Surgery
- What is being tested?
- Tranexamic acid
- How many people
- 5,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2023to 31 Dec 2023
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients undergoing elective or in-house urgent cardiac surgery at RPH between 05/2018 and 08/2022
Who may be able to join
- All patients undergoing elective or in-house urgent cardiac surgery at RPH between 05/2018 and 08/2022
Who cannot join
- Patients undergoing
- operations involving deep hypothermic circulatory arrest,
- operations involving thoracic vessels other than the ascending aorta,
- solid organ transplantation or mechanical assist device implantation,
- emergency operations
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB23 3RE
About this study
Official title: Are Higher Doses of Tranexamic Acid Associated With a Lower Incidence of Post-operative Delirium After Cardiac Surgery? A Retrospective Cohort Study
Delirium is one of the most common complications after cardiac surgery and occurs with an incidence of 3 - 70%.
Both predisposing factors (age, diabetes, severity of cardiac disease, atrial fibrillation) and precipitating factors (type of surgery, duration of cardiopulmonary bypass (CPB) and surgery, ventilator time in ICU, highest temperature in intensive care (ICU)) are difficult to influence. Post-operative delirium is a devastating complication, leading to longer ICU and hospital stay, increased incidence of discharge to nursing facility and poorer long-term cognitive outcome.
Read more
Despite the impact this complication has on individuals, their families and healthcare resources, little is known about the causes and potential preventative measures.
It is thought that systemic inflammation compromising the integrity of the blood brain barrier is an important contributing factor. Recent data suggests that antifibrinolytics like tranexamic acid (TXA) might be able to lessen the inflammation of the nervous system caused by surgery and CPB through the inhibition of plasmin production, thereby stabilising the blood brain barrier. Worldwide, the use of TXA has become standard of care in cardiac surgery and other types of surgery with a high risk of bleeding. It has been shown to reduce bleeding by 25% and significantly reduce the rate of transfusion in cardiac and noncardiac surgery.
At Royal Papworth hospital it is routine practice to administer 2g of TXA before commencing CPB irrespective of patients' body weight. We are hypothesising that there is a weight-based effect of TXA on neurological outcomes after cardiac surgery, showing a signal that a higher dose per kg bodyweight will lead to less delirium measured with the Richmond Agitation-Sedation Score (RASS). We intend to analyse 4 years' worth of patient data (05/2018 - 08/2022); the necessary information is routinely collected on using the hospital anaesthetic and ICU record.
Read the detailed description
There will be no patient contact at any point of this retrospective analysis. The data collected will have been routinely collected on the hospital's electronic systems as part of routine clinical care and data collection.
This is a very new field of interest in cardiac anaesthesia / surgery. No clinical data is currently available apart from recent preliminary data suggesting that Tranexamic Acid (TXA) improves the inflammatory reaction the nervous system has to surgery and cardiopulmonary bypass. The first trial in this area, a RCT (TXA vs no TXA) in abdominal surgery, has only just started recruiting (Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial; clinicaltrials.gov).
The statistical methods will be determined once data distribution is known; the interdependence of primary and secondary outcome measures will be determined by multivariate regression analysis.
At this stage it is not possible to devise a prospective randomised controlled trial similar the TRIGS-D study in cardiac surgery as giving TXA is considered standard of care. It might be possible, however, to design a RCT comparing different TXA dosing regimens once the the results of this retrospective analysis are available.
- Conditions
- Cardiovascular Surgery
- Being tested
- Tranexamic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Recent data suggests that antifibrinolytics like tranexamic acid (TXA) might be able to lessen the inflammation of the nervous system caused by surgery and CPB through the inhibition of plasmin production, thereby stabilising the blood brain barrier.
What is being measured
The primary outcome is the main question the study is designed to answer.
Richmond Agitation Sedation Score
Measured: Up to 48hours after surgery
Secondary outcomes (1)
30 day mortality
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Feb 2023
- Primary completion31 Mar 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966012
- Sponsor's protocol ID
- IRAS 323740
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Higher Doses of Tranexamic Acid Associated With a Lower Incidence of Post-operative Delirium After Cardiac Surgery? A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05966012
- Acronym / sponsor ID
- IRAS 323740
- Conditions
- Cardiovascular Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Jul 2023 (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.
Delirium is one of the most common complications after cardiac surgery and occurs with an incidence of 3 - 70%.
Both predisposing factors (age, diabetes, severity of cardiac disease, atrial fibrillation) and precipitating factors (type of surgery, duration of cardiopulmonary bypass (CPB) and surgery, ventilator time in ICU, highest temperature in intensive care (ICU)) are difficult to influence. Post-operative delirium is a devastating complication, leading to longer ICU and hospital stay, increased incidence of discharge to nursing facility and poorer long-term cognitive outcome.
Despite the impact this complication has on individuals, their families and healthcare resources, little is known about the causes and potential preventative measures.
It is thought that systemic inflammation compromising the integrity of the blood brain barrier is an important contributing factor. Recent data suggests that antifibrinolytics like tranexamic acid (TXA) might be able to lessen the inflammation of the nervous system caused by surgery and CPB through the inhibition of plasmin production, thereby stabilising the blood brain barrier. Worldwide, the use of TXA has become standard of care in cardiac surgery and other types of surgery with a high risk of bleeding. It has been shown to reduce bleeding by 25% and significantly reduce the rate of transfusion in cardiac and noncardiac surgery.
At Royal Papworth hospital it is routine practice to administer 2g of TXA before commencing CPB irrespective of patients' body weight. We are hypothesising that there is a weight-based effect of TXA on neurological outcomes after cardiac surgery, showing a signal that a higher dose per kg bodyweight will lead to less delirium measured with the Richmond Agitation-Sedation Score (RASS). We intend to analyse 4 years' worth of patient data (05/2018 - 08/2022); the necessary information is routinely collected on using the hospital anaesthetic and ICU record.
Detailed description
There will be no patient contact at any point of this retrospective analysis. The data collected will have been routinely collected on the hospital's electronic systems as part of routine clinical care and data collection.
This is a very new field of interest in cardiac anaesthesia / surgery. No clinical data is currently available apart from recent preliminary data suggesting that Tranexamic Acid (TXA) improves the inflammatory reaction the nervous system has to surgery and cardiopulmonary bypass. The first trial in this area, a RCT (TXA vs no TXA) in abdominal surgery, has only just started recruiting (Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial; clinicaltrials.gov).
The statistical methods will be determined once data distribution is known; the interdependence of primary and secondary outcome measures will be determined by multivariate regression analysis.
At this stage it is not possible to devise a prospective randomised controlled trial similar the TRIGS-D study in cardiac surgery as giving TXA is considered standard of care. It might be possible, however, to design a RCT comparing different TXA dosing regimens once the the results of this retrospective analysis are available.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing elective or in-house urgent cardiac surgery at RPH between 05/2018 and 08/2022
Key inclusion criteria (1 listed)
- All patients undergoing elective or in-house urgent cardiac surgery at RPH between 05/2018 and 08/2022
Key exclusion criteria (5 listed)
- Patients undergoing
- operations involving deep hypothermic circulatory arrest,
- operations involving thoracic vessels other than the ascending aorta,
- solid organ transplantation or mechanical assist device implantation,
- emergency operations
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 |
|---|---|---|
| Tranexamic acidRecent data suggests that antifibrinolytics like tranexamic acid (TXA) might be able to lessen the inflammation of the nervous system caused by surgery and CPB through the inhibition of plasmin production, thereby stabilising the blood brain barrier. | Drug | – |
Primary outcome
Richmond Agitation Sedation Score
Time frame: Up to 48hours after surgery
1 secondary outcome
30 day mortality
Time frame: Up to 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Surgery
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingObservational study
Registry of Ehlers-Danlos Syndrome
Ehlers-Danlos Syndrome
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
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?
An observational study of Cardiovascular Surgery, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 5 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 28 Jul 2023. 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 United Kingdom. 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.
What does the primary outcome measure?
Richmond Agitation Sedation Score (time frame: Up to 48hours after 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 28 Jul 2023.