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F. Paciullo et al.
approved this sub-study (CEAS Umbria, Italy, Approval n. 13138/18).
For further details see the Online Supplementary Materials and Methods.
Thromboembolic risk
VTE-risk of surgical patients was estimated using the Caprini Score.32,33 The enrolled procedures were subdivided into four classes of risk depending on the Caprini score. Surgical procedures were also classified according to procedure-related VTE-risk in three groups as suggested by the 2008 ACCP.3 Both the Caprini and the procedure-related VTE-risk scores were centrally calculat- ed based on the replies given by the participating investigators to the 48-item questionnaires. Further details are provided in the Online Supplementary Materials and Methods.
Thrombotic outcomes
Thrombotic outcomes were defined as any symptomatic thrombosis (deep venous, including distal, and superficial) and/or pulmonary embolism occurring within one month after surgery. For details see the Online Supplementary Materials and Methods.
Bleeding outcomes
Previous bleeding history was assessed using the WHO bleed- ing assessment scale (WHO-BS),34 while excessive bleeding occur- ring after surgery and the rate of success of emergency treatment of post-surgical bleeding were classified as previously described.17 Additionally, data about the need of blood transfusion after sur- gery were collected. Participating investigators were asked to pro- vide informations about bleeding outcomes occurred both during and immediately after hospitalization for surgery.
The outcome of emergency treatment of excessive post-surgi- cal bleeding was classified as successfully controlled, not respon- sive to treatment or re-bleeding.17
Statistical analysis
As this was a pilot, exploratory study without any a priori test hypothesis, we did not perform a formal sample size analysis. Variables not normally distributed were reported as medians and interquartile ranges (IQR), and differences were tested using the Mann–Whitney U test or the Kruskal-Wallis analysis of variance (ANOVA) test. Data are shown as medians and IQR. Categorical variables were analysed using the χ2 test. A Cochrane-Armitage test of trend was used to evaluate the correlation between dichotomous and ordinal variables. Logistic regression analysis was performed to identify predictors of excessive post-surgical bleeding, of heparin use, of the need for anti-hemorrhagic inter- ventions and of the success of post-surgical bleeding management. All analyses were performed using SPSS version 22.0 (IBM Corporation, Armonk, NY, USA).
Results
Patient characteristics
Out of the 829 surgical procedures included in the SPATA study, 210 carried out in 133 patients met the inclu- sion criteria, 132 of which were performed in females (63.8%), with 31 patients undergoing more than one pro- cedure. Of these interventions, 110 (52.4%) were carried out in 66 patients with 14 different forms of inherited dis- order of platelet function (IPFD), and 100 (47.6%) in 67 patients with seven different forms of inherited disorders of platelet number (IPND) (Online Supplementary Table S1). The median age at surgery was 45 years (IQR: 29-56; min
17, max 88). Two patients (0.9%), aged 19 and 26 years undergoing one procedure each, were heterozygous carri- ers of the FV Leiden mutation, although it should be con- sidered that no systematic search for thrombophilic genet- ic mutations was made in the enrolled population;11 proce- dures (5.2%) were performed in patients with a history of malignancy (median age 55 years; IQR: 52-79), and four (1.9%) in patients with chronic obstructive pulmonary disease (COPD) (median age 51 years; IQR: 42-59). 65 interventions (31%) were performed in patients with a Caprini score ≥5, 60 (28.6%) in patients with a score of 3- 4, 53 (25.2%) in patients with a score between 1 and 2, and 32 (15.2%) in patients with a score of 0. The median age was 32 years (IQR: 20-49) for patients with a score of 0, 35 years (IQR: 27-46) for patients with a score of 1-2, 46 (IQR: 32-60) for patients with a score of 3-4, and 52 years (IQR: 41-61) for patients with a score ≥5. Sixty-one inter- ventions (29%) (32 in patients with IPFD and 29 in patients with IPND) were low-risk, 114 (54%) (55 in patients with IPFD and 59 in patients with IPND) were intermediate-risk, and 35 (17%) (23 in patients with IPFD, 12 in patients with IPND) were high-risk.3 In low-risk pro- cedures, the median age was 49 years (IQR: 33-58), in intermediate-risk 37 years (IQR: 28-53), and in high-risk 53 years (IQR: 33-62).
Type of surgery and antithrombotic prophylaxis
72 procedures were abdominal (34.3%), 55 gynecologi- cal (26.2%), 41 orthopedic (19.5%), 14 urological (6.7%), 10 cardiovascular (4.8%), nine thoracic (4.3%), six neuro- surgical (2.9%), and three spine surgeries (1.3%). 90 inter- ventions were major surgery (43%) while the other 120 procedures (57%) were minor invasive interventions fol- lowed by immobilization for ≥24 hours. The oldest group of patients were those undergoing urological interventions (median age 58 years), while the youngest patients under- went gynecological surgery (median age 36 years). Malignancy was most frequent in patients undergoing thoracic surgery (Table 1). Of the overall 210 surgical pro- cedures, 89% were elective and 11% urgent.
The Caprini score was higher in patients undergoing cardiovascular interventions and lower for abdominal interventions (Table 1).
Out of 210 surgical procedures, 49 (23.3%) were man- aged with thromboprophylaxis; of these 27 (55.1%) were managed with mechanical thromboprophylaxis alone, using either compression stockings (26 procedures) or intermittent pneumatic compression (one procedure), 19 (38.8%) with LMWH alone, and three (6.1%) with both methods (mechanical and pharmacologic).
Of the 49 interventions managed with thromboprophy- laxis, 13 were orthopedic (26.0%), 12 gynecological (24.5%), seven abdominal (14.3%), seven thoracic (14.3 %), seven urological (14.3%) and three neuro-spinal (6%). LMWH prophylaxis was adopted in 22% of the orthope- dic procedures, 12.7% of gynecological, 11% of thoracic, 11% of neuro-spinal surgery, 7.1% of urological and 4.2 % of abdominal (Table 1 and Figure 1). The two patients car- riers of factor V Leiden mutation were both at intermedi- ate VTE-risk and had a low WHO-BS (0 and 2, respective- ly). They both underwent gynecological surgery without thromboprophylaxis and did not develop VTE. Patients with a history of malignancy were all classified at an inter- mediate VTE-risk, and their median WHO-BS was 2. In these patients heparin was used in four procedures,
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haematologica | 2020; 105(7)