COagulation and Platelet laboratory Testing in Cardiac surgery

COagulation and Platelet laboratory Testing in Cardiac surgery : a prospective, single-centre observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN20778544

Enrollment

2400

Registered

2011-05-11

Start date

2010-03-30

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac disease/coronary surgery Circulatory System Cardiac disease/coronary surgery

Interventions

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 th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >18 years undergoing cardiac surgery at Bristol Heart Institute

Exclusion criteria

Exclusion criteria: 1. Prisoners 2. Patients unable to give prospective or retrospective consent through mental incapacity

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026