Tranexamic Acid Dose and Confusion After Cardiac Surgery

NCT05966012 | Unknown

• 1 other identifier: IRAS 323740
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cardiovascular Surgery

Outcome Measures

Primary Outcomes (1)

• Richmond Agitation Sedation Score

  Up to 48hours after surgery

Secondary Outcomes (1)

• 30 day mortality

  Up to 30 days after surgery

Interventions

Tranexamic acid DRUG

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing elective or in-house urgent cardiac surgery at RPH between 05/2018 and 08/2022

You may qualify if:

• All patients undergoing elective or in-house urgent cardiac surgery at RPH between 05/2018 and 08/2022

You may not qualify if:

• 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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 28, 2023
• Study Start: February 1, 2023
• Primary Completion: March 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)