COagulation and Platelet laboratory Testing in Cardiac surgery

ISRCTN	ISRCTN20778544
DOI	https://doi.org/10.1186/ISRCTN20778544
Secondary identifying numbers	CS/2009/3228

Submission date: 21/02/2011
Registration date: 11/05/2011
Last edited: 27/07/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrew Mumford
Scientific

Bristol Heart Institute
Level 7, Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Phone	+44 (0)117 342 3152
Email	a.mumford@bristol.ac.uk

Study information

Study design	Prospective single-centre observational study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	COagulation and Platelet laboratory Testing in Cardiac surgery : a prospective, single-centre observational study
Study acronym	COPTIC
Study objectives	To estimate the patient benefit associated with pre and post operative measurement of coagulation factors and platelet function in cardiac surgery patients.
Ethics approval(s)	Wiltshire Research Ethics Committee, 09/09/2009
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	30/03/2010
Completion date	31/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	2400
Key inclusion criteria	Age >18 years undergoing cardiac surgery at Bristol Heart Institute
Key exclusion criteria	1. Prisoners 2. Patients unable to give prospective or retrospective consent through mental incapacity
Date of first enrolment	30/03/2010
Date of final enrolment	31/08/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Bristol Heart Institute

Bristol
BS2 8HW
United Kingdom

Sponsor information

University Hospitals Bristol NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Office
University Hospitals Bristol NHS Foundation Trust
Education Centre, Level 3
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom

Phone	+44 (0)117 34 20233
Email	mary.perkins@ubht.nhs.uk
"ROR"	https://ror.org/04nm1cv11

Funders

Funder type

Government

Programme Grants for Applied Research (UK) (ref: RP-PG-0407-10384)
Government organisation / National government

Alternative name(s): NIHR Programme Grants for Applied Research, PGfAR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/07/2017		Yes	No

Editorial Notes

27/07/2018: Publication reference added.
21/12/2017: No publications found, verifying study status with principal investigator.
01/05/2012: The overall trial end date was changed from 31/03/2012 to 31/08/2012.