The effectiveness of various groups of 24-hour tranexamic acid treatment in the prevention of systemic inflammatory response syndrome and post-operative bleeding in elective cardiopulmonary bypass patients

ISRCTN	ISRCTN84413719
DOI	https://doi.org/10.1186/ISRCTN84413719
Clinical Trials Information System (CTIS)	2004-001366-41
Protocol serial number	TX/05 v.2; EudraCT: 2004-001366-41
Sponsor	Hospital Universitario de Canarias (Spain)
Funder	Canary Islands Foundation of Health Research (Fundación Canaria de Investigación y Salud [FUNCIS]) (Spain) (ref: 48/04)

Submission date: 10/06/2009
Registration date: 15/07/2009
Last edited: 05/04/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Juan Jose Jimenez
Scientific

Ofra s/n. La Cuesta
La Laguna
38320
Spain

Email	jjjimenezrivera@gmail.com

Study information

Primary study design	Interventional
Study design	Randomised double-blind phase IV clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised double-blind phase IV clinical trial on 24 hours duration of various groups of tranexamic acid treatment on the effectiveness in the prevention of systemic inflammatory response syndrome and post-operative bleeding in elective cardiopulmonary bypass patients
Study objectives	Hyperfibrinolysis may play a role in systemic inflammatory response syndrome (SIRS) after cardiopulmonary bypass (CPB). Irregular inhibition of fibrinolysis with different doses of tranexamic acid may attenuate unequally SIRS after CPB.
Ethics approval(s)	The local medical ethics committee (Comite Etico de Investigacion Clinica del Hospital Universitario De Canarias) approved on the 1st March 2005
Health condition(s) or problem(s) studied	Systemic inflammatory response syndrome (SIRS), post-operative bleeding
Intervention	Patients were randomly assigned by independent pharmacists using a list of pseudo-randomised numbers to receive coded infusions of either tranexamic acid (TA) (40 mg/kg pre-CPB and 40 mg/kg post-CPB) or TA (40 mg/kg pre-CPB and 0 mg/kg post-CPB) after protamine administration. Patients were followed-up from the first 24 hours after surgery up to ICU discharge.
Intervention type	Drug
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Tranexamic acid, protamine
Primary outcome measure(s)	Biochemical determinations and haemodynamics parameters, recorded before intervention (baseline), on admission to the ICU after surgery (0 hours), and at 4 hours, 12 hours and 24 hours after surgery
Key secondary outcome measure(s)	1. Blood loss, measured by tube chest drainage and the amount of haemoderivatives used, as well as its frequency, collected after intervention on admission to the ICU after surgery (0 hours), and at 4 hours, 12 hours and 24 hours after surgery, and when chest tubes were removed 2. Mortality, measured from the first 24 hours after surgery up to ICU discharge 3. Mechanical ventilation time, measured from the first 24 hours after surgery up to ICU discharge 4. Vasopressor requirements, measured from the first 24 hours after surgery up to ICU discharge 5. ICU length of stay, measured from the first 24 hours after surgery up to ICU discharge
Completion date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	160
Key inclusion criteria	1. Equal or older than 18 years old, either sex 2. Elective cardiopulmonary bypass surgery 3. Informed consent approval
Key exclusion criteria	1. Younger than 18 years old 2. Tranexamic acid hypersensibility 3. Gross haematuria 4. Emergency interventions 5. Off-pump cardiac surgery 6. Patients with a history of: 6.1. Chronic coagulopathy (prothrombin time [PT] of less than 50% or international normalised ratio of greater than 2 and platelets of less than 50,000/mm^3 or aggregation dysfunction) 6.2. Renal failure (creatinine of greater than 2 mg/dl) 6.3. Chronic hepatopathy (Child B or higher degree) 6.4. Use of immunosuppressant drugs 6.5. Endocarditis, sepsis in the first 24 hours after intervention, or 6.6. Unwillingness to enrol 6.7. Use of anti-inflammatory agents such as corticosteroids or non-steroidal anti-inflammatory agents, on the previous 5 days before intervention
Date of first enrolment	01/12/2005
Date of final enrolment	01/01/2007

Locations

Countries of recruitment

Spain

Study participating centre

Ofra s/n. La Cuesta

La Laguna
38320
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	14/10/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes