Contact information
Type
Scientific
Primary contact
Dr Andrew Mumford
ORCID ID
Contact details
Bristol Heart Institute
Level 7
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
+44 117 342 3152
a.mumford@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CS/2009/3228
Study information
Scientific title
COagulation and Platelet laboratory Testing in Cardiac surgery : a prospective, single-centre observational study
Acronym
COPTIC
Study hypothesis
To estimate the patient benefit associated with pre and post operative measurement of coagulation factors and platelet function in cardiac surgery patients
As of 01/05/2012, the anticipated end date of trial was updated from 31/03/2012 to 31/08/2012.
Ethics approval
Wiltshire Research Ethics Committee approved on 9th September 2009
Study design
Prospective single-centre observational study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiac disease/coronary surgery
Intervention
Participants will undergo standard pre-operative, anaesthetic, surgical and post-operative care according to existing protocols.
1. For the research, two 22.5 ml blood samples will be obtained in the operating theatre at the following time-points:
1.1. Immediately before induction of anaesthesia
1.2. Reversal of heparin anticoagulation
Blood samples will be taken from existing arterial lines that are inserted as part of standard clinical care. No additional venepunctures are required for this study. These samples represent a total additional blood requirement of 45 ml.
Decisions about intra- and post-operative haemostasis and transfusion treatment will be guided by thromboelastography (TEG®) and other laboratory investigations, performed at the discretion of the responsible clinician in accordance with our routine institutional practice. These decisions will not be influenced by participation in this study.
2. Reference coagulation and platelet function assays
2.1. Prothrombin time
2.2. Activated partial thromboplastin time
2.3. Fibrinogen activity (Clauss assay)
2.4. Factor XIII activity (Berichrom assay)
2.5. Heparin activity (anti-Xa assay)
2.6. Endogenous thrombin potential (Thrombin generation assay in platelet poor plasma)
2.7. Von Willebrand factor activity (collagen binding assay)
2.8. D-dimer concentration
2.9. Platelet count
2.10. Immature platelet count
2.11. Mean platelet volume
2.12. Maximum amplitude of platelet aggregation to ADP (Multiplate assay)
2.13. Maximum amplitude of platelet aggregation to AA (Multiplate assay)
2.14. Maximum amplitude of platelet aggregation to TRAP (Multiplate assay)
2.15. Maximum amplitude of platelet aggregation to adrenaline (Multiplate assay)
3. TEG® analysis (post-operative sample only)
Estimates of R-time, K value, MA and LY30 parameters using kaolin and kaolin+ heparinase reagents.
4. Rotational thrombelastography analysis (ROTEM®) (post-operative sample only)
Estimates of R-time, K value and MA parameters using in-tem®, fib-tem®, ap-tem® and hep-tem® reagents
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The primary predictor and outcome of interest differ by objective. Therefore, they are defined below with respect to each objective separately.
1. Key predictors: results from pre-operative coagulopathy assays
Key outcome: clinical concern about bleeding
2. Key predictor: time between stopping clopidogrel/prasrugrel medication prior to surgery and time of surgery
Key outcomes: results from reference coagulopathy assays
3. Key predictor: time between stopping clopidogrel/prasrugrel medication prior to surgery and time of surgery
Key outcome: clinical concern about bleeding
4. Key predictors: results from post-operative reference coagulopathy assays
Key outcome: category of coagulopathy
5. Key predictors: results from reference coagulopathy assays hypothesised to predict a category of coagulopathy (separate analyses for each category of coagulopathy)
Key outcome: category of coagulopathy (compared to category no coagulopathy)
6. Key predictors: results for parameters from TEG® and ROTEM® point-of-care analysers hypothesised to predict a category of coagulopathy (separate analyses for each category of coagulopathy)
Key outcome: category of coagulopathy (compared to category no coagulopathy)
Secondary outcome measures
No secondary outcome measures
Overall trial start date
30/03/2010
Overall trial end date
31/08/2012
Reason abandoned
Eligibility
Participant inclusion criteria
Age >18 years undergoing cardiac surgery at Bristol Heart Institute
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2400
Participant exclusion criteria
1. Prisoners
2. Patients unable to give prospective or retrospective consent through mental incapacity
Recruitment start date
30/03/2010
Recruitment end date
31/08/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Heart Institute
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
University Hospitals Bristol NHS Foundation Trust (UK)
Sponsor details
Research and Development Office
University Hospitals Bristol NHS Foundation Trust
Education Centre
Level 3
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
+44 117 34 20233
mary.perkins@ubht.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Programme Grant for Applied Research (UK) (ref:RP-PG-0407-10384)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary