Major bleeding during cardiac surgery not related to vitamin K antagonists MedDRA version: 20.1 Level: LLT Classification code 10051536 Term: Intraoperative bleeding System Organ Class: 100000004863 MedDRA version: 20.1 Level: LLT Classification code 10036277 Term: Postoperative bleeding System Organ Class: 100000004863 MedDRA version: 21.1 Level: PT Classification code 10042609 Term: Surgery System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: OCTAPLEX
Product Name: OCTAPLEX
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: Human Coagulation Factor II
CAS Number: 9001-26-7
Concentratio
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =18 years - Able to give consent - Any cardiovascular surgeries excluding procedures under exclusion criteria Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: A participant is not eligible if any of the following criteria are met: - Unable to consent - Patients refusing blood transfusion for any reason - First time isolated coronary artery bypass grafts (CABG) - First time isolated aortic valve replacement (excluding active endocarditis) - Thoraco-abdominal surgeries - Minor surgeries that do not involve cardiopulmonary bypass - Use of warfarin within three days - Use of direct oral anticoagulants (i.e. dabigaran, rivaroxban, apixaban or edoxaban) within 48 hrs (or 72 hours if patient has renal impairment – i.e. estimated glomerular filtration rate of <30ml/min) - Inherited bleeding disorder (i.e. any inherited clotting factor deficiencies, or platelet disorders) - Pregnancy - Known or suspected allergy to FFP, or LG-octaplas, or PCC - Known or suspected allergy to heparin, Sodium citrate dihydrate, sodium dihydrogenphosphate dihydrate and Glycine - History of Heparin-induced thrombocytopenia - Individuals who have IgA deficiency with known antibodies against IgA - Documented venous thromboembolism in the last three months - Documented antiphospholipid syndrome - Severe Protein S deficiency - Patients who are likely to go on Extracorporeal Membrane Oxygenation (ECMO) after cardiac surgery - Any other reasons the investigator may consider the patient to be ineligible for the study - Participation in another clinical trial, where the patient has received IMP in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the recruitment rate – defined as proportion of participants who consent to the study and receive intervention.;Secondary Objective: 1. Assess the delivery of different components of the trial 2. Compare the impact of FFP and PCC on the haemostatic capacity of bleeding patients, through the use of standard clotting tests and other global clotting tests. 3. Perform qualitative research to obtain input from patients, public and healthcare professionals on the design/running of the large trial, as well as identify the most important primary/secondary outcomes for the trial. ;Primary end point(s): The proportion of eligible participants who consent, and the proportion of participants who are randomised and receive intervention within 24 hours of surgery, out of all consenting participants.;Timepoint(s) of evaluation of this end point: 24 hours post surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to study drug administration Proportion of patients for whom clinical outcome data were collected up to 90 days, or death, whichever occur first Proportion of patients who are randomised within 24 hours of surgery Proportion of participants who consent, bleed and receive a protocol intervention within 24 hours of surgery (whether or not they are randomised) Proportion of patients for whom timing of administration, and completion of intervention(s) were documented Proportion of patients where there was protocol adherence, and protocol violation Reasons for non-participation Proportion of patients who do not consent to intervention, but agree to collection of de-identified data for up to 24 hours after surgery Obtain data on event rates in control group to help estimate the sample size for the large trial Clinical data that will be collected for eligible participants who have consented but not received intervention, and those who have agreed to provide pseudo-anonymised data for up to 24 hours after surgery - Baseline data: age, gender, hospital, type of surgery, - Previous medical history - Type of surgery - Date of admission - clinical data for up to 24 hours after surgery Clinical data that will be collected for participants who have consented and who receive intervention - Baseline data: age, gender, hospital, type of surgery, - Previous medical history - Type of surgery - Date of discharge - Mortality (all cause) up to 90 days - Date and time of administration and cessation of study drug - time from intervention to chest closure - amount and type of fluid and other haemostatic agents administered in the first 24 hours after randomisation. - number of patients who require resternotomy within 24 hours of first surgery; - total blood loss collected in chest drains in first 24 hours or until drain removal (whichever comes first) - thrombotic events (arterial and venous) as confirmed by radiological imaging - overall transf | — |
Countries
United Kingdom
Contacts
Public ContactMays Jawad
Queen Mary University of London
Outcome results
None listed