Introduction
A thorough pre-operative evaluation is fundamental for stratifying haemorrhagic risk, for predicting transfusion needs in relation to the type of surgical intervention, as well as for evaluating the indications and eligibility of a patient for autotransfusion procedures, and the need for any adjuvant therapies (Grade of recommendation: 2C)1–3.
The pre-operative assessment must include a careful review of the patient’s clinical documentation, a thorough personal and family history, focused particularly on revealing a suspected bleeding disorder, as well as a control of the laboratory tests.
The evaluation must be carried out a reasonable time before the planned date of the intervention, for example 30 days before, in order to allow detailed diagnostic investigations or planning of appropriate therapeutic measures (Grade of recommendation: 2C)4.
Evaluation of haemorrhagic risk
A detailed personal and family history of any bleeding episodes must be taken from all patients who are candidates for surgery or invasive procedures (Figures 1–3, Table I) (Grade of recommendation: 2C)5–10.
Table I.
Patient’s ID_________________ sex_____ date of birth_____________ | |||||
---|---|---|---|---|---|
Epistaxis | Bleeding from minor wounds | Oral cavity | |||
0 | None or rare (<5 episodes) | 0 | None or mild (<5 episodes) | 0 | No |
1 | >5 episodes or >10 min/episode | 1 | >5 episodes or >5 min/episode | 1 | Reported at least 1 episode |
2 | Only medical consultation | 2 | Only medical consultation | 2 | Only medical consultation |
3 | Packing or cauterisation or antifibrinolytic | 3 | Surgical haemostasis | 3 | Surgical haemostasis or antifibrinolytic |
4 | Transfusion or replacement therapy or DDAVP | 4 | Transfusion or replacement therapy or DDAVP | 4 | Transfusion or replacement therapy or DDAVP |
Menorrhagia | Muscle haematomas | Joint bleeds | |||
0 | No | 0 | None | 0 | None |
1 | Only medical consultation | 1 | After trauma, no treatment | 1 | After trauma, no treatment |
2 | Antifibrinolytic and OC | 2 | Spontaneous, no treatment | 2 | Spontaneous, no treatment |
3 | DDAVP or replacement therapy or iron treatment | 3 | Spontaneous or traumatic, requiring treatment | 3 | Spontaneous or traumatic, requiring treatment |
4 | Transfusion or replacement therapy or DDAVP or hysterectomy | 4 | Spontaneous or traumatic, requiring surgery or transfusions | 4 | Spontaneous or traumatic, requiring surgery or transfusions |
Dental extractions | Surgery | Post-partum bleeding | |||
– 1 | No bleeding after ≥2 extractions | – 1 | No haemorrhage in ≥2 operations | – 1 | No haemorrhage in ≥2 deliveries |
0 | No extractions or no bleeding after 1 extraction | 0 | No surgery or no haemorrhage in = 1 operation | 0 | No deliveries or no haemorrhage after 1 delivery |
1 | Reported in <25% of all procedures | 1 | Reported in <25% of all operations | 1 | Only medical consultation |
2 | Reported in >25% of all procedures, no intervention | 2 | Reported in >25% of all operations | 2 | DDAVP or replacement therapy or iron treatment or antifibrinolytic |
3 | Re-suturing or packing | 3 | Surgical haemostasis or antifibrinolytic | 3 | Transfusion or replacement therapy or DDAVP |
4 | Transfusion or replacement therapy or DDAVP | 4 | Transfusion or replacement therapy or DDAVP | 4 | Hysterectomy |
Skin Gastrointestinal bleeding | CNS bleeding | ||||
0 | None or mild (<1 cm) | 0 | None | 0 | None |
1 | >1 cm and without trauma | 1 | Associated with ulcer, portal hypertension, haemorrhoids, angiodysplasia | 1 | - |
2 | Only medical consultation | 2 | Spontaneous | 2 | - |
3 | - | 3 | Surgical haemostasis or transfusion or replacement therapy or DDAVP or antifibrinolytic | 3 | Subdural, any intervention |
4 | - | 4 | - | 4 | Intracerebral, any intervention |
Total score:___________ (attention if >0) |
Legend: DDAVP = desmopressin; ID = identity code; CNS = central nervous system; OC = oral contraceptive.
A well-conducted clinical interview should elicit information on any spontaneous, post-traumatic or post-surgical bleeding, any use of anticoagulant and anti-aggregant drugs (Grade of recommendation: 2C)2 and include the family history (Grade of recommendation: 2C)2,11.
For those patients with a positive history of bleeding, it may be helpful to use a structured questionnaire12, such as the one shown in Table I13, and a scheme to evaluate menorrhagia (Figure 2) in order to quantify the haemorrhagic risk (Grade of recommendation: 2C)14,15.
Indiscriminate screening of coagulation parameters in unselected patients who are candidates for surgery or invasive procedures, in the absence of a history suggestive of bleeding, cannot be recommended (Grade of recommendation: 2C+)2,16,17. In the presence of a history of bleeding or a clear indication (for example, liver disease) further diagnostic laboratory tests are necessary; these should be guided by clinical findings and the history and clinical features of the patient (Grade of recommendation: 2C)2. A platelet count is, however, advisable before surgery and invasive procedures (excluding diagnostic endoscopies) (Grade of recommendation: 2C)18.
The contemporaneous presence of anaemia and thrombocytopenia increases haemorrhagic risk19–31. In anaemic and thrombocytopenic patients (platelet count ≤20x109/L) who are candidates for surgery or invasive procedures, the haemorrhagic risk can be reduced by increasing the haematocrit to around 30% (besides correcting the platelet count to levels appropriate for the management of the procedure to be carried out) (Grade of recommendation: 1C+)19–31.
Laboratory tests
The laboratory tests commonly used to evaluate haemorrhagic risk are the prothrombin time (PT)32, which explores the extrinsic and common coagulation cascades, the activated partial thromboplastin time (aPTT), which explores the intrinsic and common coagulation cascades, and the platelet count. Both the PT and the aPTT can be altered in various situations, which may lead to a physiological response being masked. For example, the levels of factor VIII (FVIII) increase during pregnancy and in response to stress and inflammatory states.
This causes a shortening in the aPTT, which can mask a mild form of haemophilia or von Willebrand’s disease. Contrariwise, lengthening of the aPTT due to the presence of a lupus inhibitor is not associated with an increased risk of bleeding.
Further examinations are assays of fibrinogen and the clotting factors [von Willebrand factor (vWF), factor II, factor V, factor VII, FVIII, factor IX, factor X, and factor XI], the bleeding time, and platelet function tests33,34. The utility of the bleeding time, even when standardised, is limited by the poor sensitivity and specificity of this test2.
Figure 3 is a flow diagram illustrating the procedures to adopt for the initial evaluation and investigation of coagulation status (Grade of recommendation: 2C)35–37.
A lack of factor XII does not increase haemorrhagic risk, while, in selected cases in which no laboratory anomalies are apparent but there is a history of significant bleeding, it is suggested that platelet function is evaluated and factor XIII assayed (Grade of recommendation: 2C)38,39.
Treatment of defects of haemostasis
In the case of a clotting defect, replacement therapy with the deficient factor should be instituted (Grade of recommendation: 1A)40–44. Table II lists the inherited bleeding disorders, the haemostatic levels of the deficient factors and the mean dose of the specific factor or plasma necessary for the replacement therapy41.
Table II.
Deficient factor | Haemostatic plasma levels (IU/dL) | Factor half-life (hours) | Dose of specific concentrate (IU/kg) | PCC (IU/kg) | Dose of plasma (mL/kg) |
---|---|---|---|---|---|
Fibrinogen | 30–50 mg/dL | 72 | 20–30 mg/kg | - | 15–20 |
Prothrombin | 20–30 | 72 | - | 20–30 | 15–20 |
Factor V | 10–15 | 36 | - | - | 15–20 |
Factor VII | 10–15 | 4–6 | 30–40 | - | - |
Factor VIII | 50–100 | 8–12 | 50–100 | - | - |
Factor IX | 50–100 | 20–24 | 50–100 | - | - |
Factor X | 10–15 | 40 | - | 20–30 | 15–20 |
Factor XI | 5–10 | 60 | 15–20 | - | 15–20 |
Legend: PCC=prothrombin complex concentrate.
In type I von Willebrand’s disease, the drug of first choice for patients with vWF levels of 10 IU/dL or higher is desmopressin (DDAVP) (Grade of recommendation: 2B)42. vWF/FVIII concentrates are indicated for patients who do not respond to DDAVP (patients with severe type 1, types 2 and type 3 von Willebrand’s disease) (Grade of recommendation: 2B)42.
vWF concentrates without FVIII can be an alternative to vWF/FVIII concentrates as prophylaxis against bleeding in elective surgery (Grade of recommendation: 2C)42,45.
Thrombocytopenia
The suggested prophylaxis in the case of thrombocytopenia is as follows19:
- major surgery or invasive procedures such as lumbar puncture, epidural anaesthesia, liver biopsy, endoscopy with biopsy, placement of a central venous catheter: bring the platelet count to above 50x109/L (Grade of recommendation: 2C+)46–51;
- operations to critical sites, eye surgery and neurosurgery: administer prophylactic transfusions if the platelet count falls below the threshold of 100x109/L (Grade of recommendation: 2C)19,46–49;
- in patients with acute disseminated intravascular coagulation, in the absence of bleeding: reserve prophylactic platelet transfusions for those cases in which the thrombocytopenia and stratification of haemorrhagic risk indicate a high probability of bleeding (Grade of recommendation: 2C)52.
With regards to the treatment of thrombocytopenia:
- the surgical patient who is bleeding usually requires a platelet transfusion if his or her platelet count is below 50x109/L and rarely requires such a transfusion if the platelet count is above 100x109/L (Grade of recommendation: 2C)19,46–48,53;
- during massive transfusions, when the volume of red cell concentrate transfused is approximately double that of the circulating blood volume, a platelet count of 50x109/L can be expected; a transfusion threshold of 75x109/L is, therefore, suggested in those patients with active bleeding, in order to guarantee them a margin of safety and prevent the platelet count from dropping below 50x109/L, the critical threshold for haemostasis. A higher platelet count has been recommended for patients with multiple trauma resulting from high velocity accidents or with lesions involving the central nervous system (Grade of recommendation: 2C)19,54;
- in acute disseminated intravascular coagulation, in the presence of considerable bleeding and thrombocytopenia, besides treatment of the underlying disease and restoration of normal levels of clotting factors, the platelet count must be monitored and coagulation screening tests performed (PT, aPTT, fibrinogen, antithrombin, D-dimer). There is not a consensus on the target platelet count, but in the presence of substantial bleeding, it could be reasonable to maintain the platelet count around 50x109/L (Grade of recommendation: 2C)19,52,55.
Platelet disorders
Platelet transfusions are indicated, independently of the platelet count, for the prophylaxis of haemorrhage in patients with platelet function defects (congenital or acquired) at high risk of bleeding who must undergo surgery or an invasive procedure at high haemorrhagic risk, as well in the presence of peri-operative haemorrhage (Grade of recommendation: 2C)19,50.
Recombinant activated factor VII
The main indications for the use of recombinant activated factor VII (rFVIIa) are peri-operative prophylaxis and the treatment of bleeding in patients with haemophilia A or B with inhibitors, in whom replacement treatment with the deficient factor is not possible or not indicated (Grade of recommendation: 2C)56,57 and in patients with acquired haemophilia (Grade of recommendation: 2C+)57, inherited FVII deficiency (Grade of recommendation: 2C+)41,58,59, or Glanzmann’s thromboasthenia associated with refractoriness to platelet transfusion (Grade of recommendation: 2C)19,46,60.
In recent years there has been a notable increase in the use of rFVIIa for “off label” indications such as the treatment of haemorrhage due to secondary coagulopathies in patients undergoing surgery or in those with multiple trauma61, despite uncertainty about the risk of thrombotic complications associated with the use of this drug for unregistered indications62,63.
The use of rFVIIa, mainly in the setting of uncontrolled studies, has also been the subject of recommendations, based on the consensus of experts, for the treatment of massive haemorrhage in surgical, obstetric and gynaecological patients64–66. A recent Cochrane systematic review recommended using rFVII only in clinical trials, since its true efficacy as a haemostatic drug, both for prophylaxis and for the treatment of major bleeding, is still uncertain67. However, reports of adverse arterial thromboembolic events have recently led the European Medicines Agency (EMEA) to contraindicate the use of rFVIIa for purposes other than the approved indications68,69.
Desmopressin
According to a review from the Cochrane Library70, the use of DDAVP limits blood losses in the peri-operative period, but not to a clinically important extent, and does not significantly reduce the transfusion of red cell concentrates. The authors, therefore, concluded that there is not currently evidence to support the use of DDAVP to contain peri-operative blood losses and transfusion requirements in patients who do not have inherited bleeding disorders (Grade of recommendation: 1C)70–73.
Antithrombin deficiency
Replacement therapy with antithrombin (AT) is almost exclusively indicated for patients with congenital AT deficiency in particular situations characterised by an imbalance in haemostasis towards thrombosis (Grade of recommendation: 2C)74–76.
There is no clinical evidence that above normal levels of AT guarantee better protection than physiological levels75,77,78.
A recent meta-analysis77,78 on the use of AT in critically ill patients did not demonstrate any significant effect on the reduction of mortality either globally or in the subgroups of studies carried out in obstetric patients or in those with trauma; however, an increase in haemorrhagic risk was revealed75,77,78.
Calculation of the dose of antithrombin to administer
Before giving replacement therapy with the specific concentrate, it is advisable to assay AT function (Grade of recommendation: 2C)75.
Given that a dose of 1 IU/kg of body weight increases plasma AT activity by 1.5%, the dose to administer can be calculated as follows:
The dose and timing of subsequent administrations are based on the results of monitoring the plasma activity of AT every 12–48 hours.
Side effects and adverse reactions
AT infusions are generally well tolerated although allergic reactions are possible75.
The use of AT concentrates contemporaneously with the administration of heparin increases the risk of bleeding and for this reason careful clinical and laboratory controls are necessary in this situation (Grade of recommendation: 2C)75.
Evaluation of concurrent therapy Antiplatelet drugs
The patient’s drug history must be taken, aimed at determining any use of anti-aggregant therapies (Grade of recommendation: 1C+)79.
Besides the strictly anti-aggregant drugs (aspirin, clopidogrel, dipyridamole, ticlopidine, abciximab), which inhibit platelet function with different mechanisms, effectiveness and duration80–82, non-steroidal anti-inflammatory drugs also have an antiplatelet effect through the inhibition of cyclo-oxygenase (COX 1)45,83.
The anti-aggregant drugs and non-steroidal anti-inflammatory drugs have an irreversible effect and do not have antidotes, so their use must be suspended some days before a planned intervention (Grade of recommendation: 2C)17,45,84–87.
Oral anticoagulants
As for the antiplatelet drugs, oral anticoagulant therapy (warfarin, acenocoumarol) must be suspended at least 4 days before surgery to allow the PT and International Normalised Ratio to return to the norm (Grade of recommendation: 2C)88.
In preparation for surgery that cannot be deferred, patients receiving vitamin K antagonists must be treated with prothrombin complex concentrates, which are the first choice of treatment, or, if these are not available, with fresh-frozen plasma, in order to normalise the parameters of coagulation (Grade of recommendation: 1C+)19,75,89–94.
Heparin and thrombolytic drugs
Low-dose (prophylactic) unfractionated heparin (UFH) seems to be associated with a low risk of haemorrhage during anaesthesia and surgery95. Nevertheless, in patients receiving treatment with heparin, spinal anaesthesia and neurosurgical interventions should be avoided for at least 6 hours after suspension of the last dose of UFH and for at least 12 hours after treatment with low molecular weight heparins (LMWH), since the activity of these drugs peaks 4 hours after injection and lasts for 24 hours.
Patients receiving therapeutic doses of heparin have high intra- and post-operative risks of bleeding, so UFH and LMWH should be suspended for 6 and 12 hours, respectively (Grade of recommendation: 2C+)95.
In emergency situations, the anticoagulant effect of heparin can be antagonised by protamine sulphate (Grade of recommendation: 2C+)95.
When necessary, heparin administration can be restarted approximately 12 hours after completion of the intervention (Grade of recommendation: 2C+)96–98.
Surgical procedures should, generally, be postponed in patients receiving thrombolytic drugs, even though these have a short half-life (Grade of recommendation: 2C)96–98.
The effects of herbal remedies
Herbal remedies are very widely used in the population as supplementary or alternative therapies3,99–102. The use of such remedies is often not reported, since they are considered dietary integrators; however, many of them can affect coagulation and should, therefore, be suspended before an operation, at different times prior to the intervention depending on their duration of action (Grade of recommendation: 2C )103,104.
Garlic potentiates the effect of warfarin and has antiplatelet properties, so it is advisable to suspend its assumption 7 days before a planned intervention (Grade of recommendation: 2C)105. Ginko biloba has an antiplatelet effect, and it has been suggested that this should be suspended 36 hours before an intervention (Grade of recommendation: 2C)105. The antiplatelet effect of ginseng is irreversible, so this product should be suspended for 7 days (Grade of recommendation: 2C)105.
Other herbal remedies with antiplatelet effects are blueberries, bromelain, flaxseed oil, ginger and grape seed extract104. St. John’s wort and green tea, in contrast, accelerate the metabolism of warfarin, reducing its effect.
Evaluation of haemoglobin
The level of haemoglobin, related to other conditions that cause organ ischaemia, such as cardiorespiratory disorders, influences the threshold for transfusion of red blood cells106,107.
Patients with low levels of haemoglobin (<130 g/L in men and <120 g/L in women) have a higher risk of requiring allogeneic transfusion; to minimise this possibility, pharmacological measures should be used to correct their red cell mass before an operation (Grade of recommendation: 2C)1,4.
A simple strategy for sparing a patient’s blood is to limit the frequency of laboratory controls, the volume of blood sampled and the number of tests requested (Grade of recommendation: 2C)108.
Since blood transfusion is associated with an increase in morbidity and mortality in all surgical patients, a considerable amount of research has been carried out on how to limit or eliminate the use of allogeneic transfusions63,109,110.
Anaemia is a common finding in patients who are candidates for elective surgery111,112.
The relationship between erythropoiesis, erythropoietin and iron, studied in patients undergoing pre-operative autologous blood donation, shows the bone marrow response to post-haemorrhagic anaemia113. In response to the collection of one unit of blood a week, under the standard conditions of an autologous donation regimen, endogenous erythropoietin stimulates the production of 397–568 mL of red blood cells, equivalent to 2–3 units of whole blood. Exogenous erythropoietin treatment in patients pre-depositing autologous blood produces from 358 to 1102 mL of red blood cells, equivalent to 2–5 units of whole blood33,114.
The response to treatment with exogenous erythropoietin115 in patients with an adequate iron store is independent of the iron supply, as demonstrated in a cohort of patients with haemochromatosis, who did not have a greater response than that of controls116. It is, however, difficult for the iron supply to be increased in healthy subjects to the level necessary to support a rate of erythropoiesis of this degree, whereas this can be achieved in situations such as haemochromatosis or intravenous administration of iron117.
There is a good correlation between the dose of erythropoietin and red blood cell production118, which can be estimated to be four times higher than the basal levels, independently of sex and age119.
In patients with substantial iron deficiency, oral iron assumption is not sufficient to correct the induced dyserythropoiesis and intravenous iron administration should be considered (Grade of recommendation: 1C+)117,120–123.
The so-called “iron-limited” erythropoiesis, which occurs during treatment with erythropoietin, should also be corrected by the intravenous administration of iron (Grade of recommendation: 1C+)116,117.
Numerous, well-designed studies have examined the risks and adverse events related to the use of intravenous iron, particularly allergic and vasomotor reactions, which are independent of the dose and occur in about 5% of the patients: 0.7% of these reactions can be life-threatening123–125. Iron gluconate and iron sucrose have a better safety profile than iron dextran123–128. The rate of adverse events, in particular allergic reactions, appears to be lower with iron gluconate (the only preparation for intravenous administration available in Italy) than with iron dextran (3.3 and 8.7 episodes per million doses, respectively)33.
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