Before starting treatment with ReoPro, a thorough assessment of the benefit / risk ratio should be carried out. In patients with low risk, but above 65 years, a favorable benefit / risk ratio is not achieved.
RheOpro should be administered only if the following conditions are met: the availability of experienced specialists and appropriate equipment for transfusion of blood products, the possibility of appropriate care and the conduct of appropriate hematological tests.
It is recommended to use with caution the preparation of ReoPro in the following cases:
- reception of oral anticoagulants during the previous 7 days with a decrease in prothrombin time by 1.2 and more compared to baseline;
- intravenous dextrans before coronary angioplasty;
- body weight below 75 kg;
- age over 65;
- unsuccessful or prolonged (more than 70 min) percutaneous coronary intervention;
- Coronary angioplasty within 12 hours after the development of acute myocardial infarction.
Precautions associated with bleeding.
Treatment of ReoPro is associated with an increase in the frequency of bleeding,in particular at the site of arterial access for insertion of a catheter into the femoral artery. The following are specific recommendations for precautionary measures at the access point.
Catheterization of the femoral artery
- Use only arterial access (avoid insertion of the catheter into the vein).
- Only point the front wall of the vessel.
- The method of end-to-end approaches for determining the vascular structure is not recommended.
When a catheter is in the femoral artery
- Check the location of the catheter insertion and the distal pulse on the corresponding leg (s) every 15 minutes for the first hour, then every hour for 6 hours.
- The patient should be on the bed with an elevated angle of no more than 30 ° the head end in a state of complete rest.
- Maintain the corresponding leg (legs) in the extended position with rollers from the sheet or soft immobilization.
- If necessary, eliminate pain in the back and inguinal area medically.
- Consult a patient on how to behave after a percutaneous coronary intervention.
Removal of a catheter from the femoral artery
- The administration of heparin must be discontinued no less than 2 hours before the removal of the arterial catheter.
- Before removing the arterial catheter, you need to check the APTT or ABC: do not withdraw the catheter until APTTV is set <50 seconds or ABC <175 seconds.
- After removing the catheter, firmly press the access site for at least 30 minutes.
- After reaching the hemostasis, apply a pressure bandage.
After removal of the catheter from the femoral artery
- Check for bleeding / hematoma in the groin and distal pulse every 15 minutes for the first hour or until a stable condition is established. Next - every hour for 6 hours after removal of the catheter.
- Continue to maintain the patient's complete resting state. The patient should continue to be in a state of complete rest on the bed with an elevated angle of at most 30 ° the head of the bed and with elongated legs for 6-8 hours after removal of the catheter from the femoral artery, 6-8 hours after stopping the introduction of ReoPro or 4 hours after stopping the administration of heparin, depending on which procedure will be completed later.
- Before lifting the patient from bed, it is necessary to remove the pressure bandage.
Stop bleeding with the formation of a hematoma (or without) at the access point to the femoral artery
- Lower the head of the bed to 0 °.
- Press the access site manually or with a pressure device until the bleeding stops.
- Any hematoma must be measured and controlled to increase it.
- If necessary, change the pressure bandage.
- Before the appointment of heparin, it is necessary to measure the APTT and select a dose of heparin. Preserve venous access if the catheter has been removed.
If, despite these measures, inguinal bleeding continues or the hematoma increases in size during the infusion of ReoPro, the infusion of ReoPro should be stopped immediately and, in accordance with the recommendations outlined above, remove the arterial catheter. After removal of the catheter, the venous access should be maintained until control of the bleeding is restored.
Uncontrolled bleeding
In case of serious profuse bleeding or if an emergency surgical procedure is necessary, the introduction of ReoPro should be discontinued. In most patients, bleeding time returns to 12 minutes for 12 hours. If the bleeding time remains longer than 12 minutes, you can enter 10 units of platelet mass. ReoPro can be displaced from endogenous platelet receptors, followed by binding to transfused platelets.However, a single transfusion may be sufficient to reduce the blockade of receptors to 60-70%. With this level of blockade, the function of platelets is restored. To maintain bleeding time at 12 minutes or less, repeated transfusions of platelet mass may be required.
Possible places of bleeding
Attention should be paid to all possible bleeding sites, including venous and arterial puncture sites, catheter insertion sites, venesection sites and needle points.
Retroperitoneal bleeding
During the introduction of ReoPro, the risk of retroperitoneal bleeding associated with puncture of the femoral vessels increases. The use of femoral catheters should be kept to a minimum, and when establishing vascular access, only the front wall of the arteries or veins should be pointed.
Pulmonary haemorrhage
Introduction ReoPro is not often the cause of pulmonary (mainly alveolar) bleeding, which can be accompanied by: hypoxemia, increased alveolar infiltration on the roentgenogram of the chest, hemoptysis, or a decrease in hemoglobin of an unknown etiology.In case of confirmation of bleeding, the introduction of ReoPro, all anticoagulants and antiaggregants should be discontinued.
Prevention of gastrointestinal bleeding
To prevent gastrointestinal bleeding, it is recommended to prescribe patients with histamine H antagonists2-receptors or solutions of antacids. If necessary, antiemetics should be prescribed.
General Nursing Care
It should be avoided without the need for puncture of arteries and veins, intramuscular injections, routine catheterization of the bladder, nasotracheal intubation, the introduction of a nasogastric tube and the imposition of an automatic pressure cuff. When creating a venous access, non-compressible sites (for example, subclavian or jugular veins) should be avoided. Blood fetuses should be taken from a catheter, for the flushing of which heparin or physiological saline should be used. Puncture sites need to be documented and monitored. When removing the bandages, you need to be extra careful.
Dynamic monitoring of the patient
Before the introduction of ReoPro to detect existing disorders of blood clotting, it is necessary to determine the number of platelets, ABC, prothrombin time and APTT.
Additional platelet counts should be taken 2-4 hours later, and 24 hours after bolus administration. Before the introduction of ReoPro, and also at 12 and 24 hours after the bolus is administered, it is necessary to determine the level of hemoglobin and hematocrit. Before the introduction of the RheoPro bolus, when returning the patient to the ward from the catheterization laboratory and 24 hours after the administration of the RheoPro bolus, a 12-channel ECG should be made. Vital signs (including blood pressure and pulse) should be evaluated every hour for the first 4 hours after the administration of the RheoPro bolus and at 6, 12, 18 and 24 hours after the bolus is administered.
Recovery of platelet function
In the event of serious uncontrolled bleeding or the need for emergency surgery, the introduction of ReoPro must be discontinued. In most patients, bleeding time is normalized within 12 hours. In case of prolonged bleeding time, and / or obvious suppression of platelet function, if rapid hemostasis is required, and / or lack of adequate hemostatic recovery, the decision should be based on the recommendation of a hematologist with experience in diagnosing and managing patients with bleeding.If it is necessary to achieve rapid hemostasis, a platelet mass (at least 5.5 x 1011 thrombocytes). There may be a redistribution of ReoPro from the endogenous platelet receptors to the platelets received during transfusion. Single transfusion can reduce blockade of receptors to 60-70% of the level at which the function of platelets is restored. To maintain hemostasis, repeated platelet transfusions may be required.
Thrombocytopenia
To reduce the likelihood of thrombocytopenia, the number of platelets should be monitored before treatment, 2-4 hours after the bolus injection of ReoPro and after 24 hours. If the patient shows an acute drop in the number of platelets, it is necessary to conduct an additional determination of the number of platelets. Blood samples for these studies should be collected in three separate tubes containing ethylenediaminetetraacetic acid (EDTA), citrate and heparin, respectively, to exclude pseudothrombocytopenia due to interactions of anticoagulants in vitro. If true thrombocytopenia is confirmed, then ReoPro should be immediately discontinued and appropriate monitoring and treatment performed.The daily number of platelets should be determined as long as their number does not return to normal. If the patient's platelet count drops to 60,000 cells / μl, then heparin and aspirin should be discontinued. If the platelet count falls below 50,000 cells / μl, platelet transfusion should be addressed, especially in case of bleeding and / or current or planned invasive procedure. If the platelet count falls below 20,000 cells / μl, transfusion of platelet mass should be performed. The question of transfusion of platelet mass should be decided on the basis of the clinical picture individually.
Repeated administration.
Introduction RheoPro can lead to the formation of human anti-chimeric antibodies (CHAHA), which potentially can cause hypersensitivity and allergic reactions (including, anaphylactic reactions), thrombocytopenia and a decrease in the beneficial effect upon repeated administration. In the Phase III studies, CHAXs usually appeared in low titers in about 5-6% of patients after a single injection of ReoPro. The available data indicate that human antibodies to other monoclonal antibodies cross-react with ReoPro.
Re-introduction of RheoPro to patients undergoing percutaneous coronary interventions was evaluated in a register that included 1,342 appointments in 1,284 patients. The majority of patients had a second injection of ReoPro, 15% of patients had a third and subsequent administration. The total number of CHAX-positive before reintroduction was 6% and increased to 27 % after repeated administration. No serious allergic and anaphylactic reactions have been reported. Thrombocytopenia was more frequent in studies with repeated administration than in phase III studies with a single administration, suggesting a possible relationship between repeated administration and increased frequency and severity of thrombocytopenia.
Kidney Diseases
In patients with kidney disease, the positive effects of RheoPro can be reduced. The decision to use ReoPro in patients with severe renal failure should be taken after a thorough assessment of the risk and benefit. Since the potential risk of bleeding in patients with severe renal disease is elevated, patients should be monitored more carefully for bleeding.In case of serious bleeding, the question of transfusion of platelet mass should be decided. In patients on dialysis, the use of ReoPro is contraindicated.
Recommendations for transportation and storage.
RhePro does not contain preservatives and is intended for single use only. Unused portions must be poured. To carry out intravenous infusion, the solution of ReoPro must be prepared immediately before administration.
When transporting the drug, special containers with cooling elements (coolers 8 MSZ and 4 MC28) should be used to avoid violation of temperature storage conditions.