Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery
Study Details
- Unmapped
- Drug: Prothrombin Complex Concentrate, Human
- Drug: Fresh Frozen Plasma
- Age between 18 and 80 years.
- Undergoing elective coronary artery bypass grafting (CABG) or valve replacement or valvuloplasty through CPB.
- Signing of the informed consent form.
- Developing coagulation factor deficiency or coagulopathic bleeding during the surgery, meeting the indications of PCC or FFP treatment: a) prolonged APTT (\> 45 s) measured 20 minutes after CPB, and b) excessive bleeding observed.
- History of cardiac surgery.
- Severe hepatic dysfunction before surgery.
- Coagulopathy before surgery, including inherited or acquired coagulation factor deficiencies, thrombocytopenia, platelet dysfunction and other bleeding disorders.
- Use of warfarin and INR \> 1.2 before surgery.
- Withdrawal of clopidogrel less than 5 days and low molecular weight heparin less than 12 hours before surgery.
- Allergy to allogeneic blood products.
- Pregnancy.
- Other serious diseases that may affect patient survival time, such as cancers.
Protocol Summary
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.