Condition category
Circulatory System
Date applied
21/02/2011
Date assigned
11/05/2011
Last edited
20/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes