Intermittent Pneumatic Compression in Addition to Standard Prophylaxis of Postoperative Venous Thromboembolism in Extremely High-risk Patients (IPC SUPER): A Randomized Controlled Trial.

OBJECTIVE: To assess the efficacy of adjunctive IPC to standard prophylaxis of postoperative VTE in patients at extremely high-risk. SUMMARY OF BACKGROUND DATA: The standard prophylaxis for postoperative VTE is insufficient in extremely high-risk patients. It is unclear whether an adjunctive use of IPC would result in a lower incidence of postoperative venous thrombosis. METHODS: We randomly assigned patients who underwent major surgery and had a Caprini score of ≥11 to receive either IPC in addition to standard prophylaxis with anti-embolic stockings (pressure of 18-21 mm Hg at the ankle) and low-molecular-weight heparin (IPC group) or standard prophylaxis alone (control group). The primary outcome was an asymptomatic venous thrombosis of the lower limbs, as detected by duplex ultrasound scan performed before inclusion and every 3-5 days after surgery. RESULTS: A total of 407 patients underwent randomization, of which 204 were assigned to the IPC group and 203 to the control group. The primary outcome occurred in 1 (0.5%) patient in the IPC group and 34 (16.7%) patients in the control group [relative risk, 0.03, 95% confidential interval (CI): 0.01-0.21]. Pulmonary embolism occurred in none of the 204 patients in the IPC group and in 5 (2.5%) patients in the control group (relative risk, 0.09; 95% CI, 0.01-1.63), and postoperative death occurred in 6 (2.9%) patients in the IPC group and 10 (4.9%) in the control group (relative risk, 0.50; 95% CI, 0.50-1.60). CONCLUSIONS: Among patients with a Caprini score of ≥11 who received standard prophylaxis for VTE, adjunctive IPC resulted in a significantly lower incidence of asymptomatic venous thrombosis.

Utilization of the Caprini score in conjunction with thrombodynamic testing reduces the number of unpredicted postoperative venous thromboembolism events in patients with colorectal cancer.

BACKGROUND: The thrombodynamic test (TD) is a novel global test of hemostasis that allows to study the spatial-temporal characteristics of a clot formation in real time under conditions close to natural ones and demonstrates high sensitivity to detect the state of hypercoagulation. The main paraments of the test are the velocity of clot growth, clot's size, and clot density. The objective of this study was to compare the classic Caprini 2005 score and its modified version in association with the results of TD. The goal is to predict postoperative venous thromboembolism (VTE) in surgical patients undergoing surgery for colorectal cancer. METHODS: This was a prospective observational clinical study involving 80 patients (33 men and 47 women; mean age, 73.9 ± 7.2 years) who underwent major (79 cases) or minor (1 case) surgery for colorectal cancer. Patients were at high risk for postoperative VTE (ie, a mean Caprini score of 9.9 ± 2.0) and received combined prophylaxis (ie, antiembolic compression stockings and enoxaparin 40 mg once daily) until discharge. Enoxaparin was administered at a fixed time of blood sampling for the TD test. Duplex ultrasound scan was performed to detect postoperative vein thrombosis before and 5 to 7 days after surgery. RESULTS: Postoperative vein thrombosis was found in 21 of 80 patients (26.3%; 95% confidence interval, 17.9%-36.8%). Regression analysis and receiver operating characteristic (ROC) curve showed that Caprini scores significantly predicted VTE (P < .0001; area under the curve [AUC] = 0.839 ± 0.045). Analysis of ROC curve coordinates showed that a cutoff point of 11 scores had a sensitivity of 76.2% and a specificity of 74.6%. The results of the TD test showed significant hypercoagulation despite enoxaparin administration in patients with VTE. Regression analysis and ROC curves demonstrated that the following TD parameters had the greatest predictability for postoperative DVT: initial velocity of clot growth (Vin) and clot size (CS) measured at 12 hours after enoxaparin administration (AUC, 0.697 ± 0.063 and AUC, 0.790 ± 0.059, respectively), as well as Vin and CS measured 24 hours after the enoxaparin injection (S = 0.847 ± 0.059 and S = 0.803 ± 0.069, respectively). The cutoff points for VTE prediction at 12 and 24 hours seemed to be a Vin of greater than 62.5 and greater than 64.5 µm/minute (normal range, 35-56 µm/minute) as well as a CS of greater than 1351.5 and greater than 1333.5 µm (normal range, 800-1200 µm), respectively. Identified thresholds for TD parameters have been integrated into Caprini scores under the item "other congenital or acquired thrombophilia." The total Caprini scores were recalculated in patients where one or all TD parameters had exceeded the cutoff followed by reanalysis of the ROC curves. The best predictability was found for Caprini scores considering the elevation of all four TD parameters (AUC, 0.924 ± 0.029) with increased cutoff to a score of 12 with a sensitivity of 85.7% and a specificity of 81.4%. The use of cutoffs for the original and modified scores could be used to calculate the number of patients that were under cutoff but developed with VTE: 10.2% and 5.9%, respectively. CONCLUSIONS: Integrating TD parameters into the Caprini score increases the ability to predict postoperative VTE.

Validation of the Caprini risk assessment model for venous thromboembolism in high-risk surgical patients in the background of standard prophylaxis.

OBJECTIVE: We used the Caprini venous thromboembolism risk assessment score to prospectively evaluate if there was a correlation between the Caprini scores and the incidence of postoperative deep vein thrombosis (DVT) in high-risk surgical patients. A second objective was to determine whether patients at extremely high risk need a more effective prophylactic regimen. METHODS: This prospective multicenter observational study involved 140 high-risk patients who underwent abdominal (48%) or cranial and/or spinal (52%) surgery. All patients were assessed using the Caprini model and had a mean score of 9.5 ± 2.7 (range, 5-15). Our standard prophylaxis for venous thromboembolism consisted of above-knee graduated compression stockings with 18 to 21 mm Hg pressure and subcutaneous low-dose unfractionated heparin three times per day, starting on the first or second through the fifth postoperative day depending on the risk of bleeding. We performed a duplex ultrasound examination at baseline during the first 12 to 24 hours after surgery and then every 3 to 5 days until discharge to assess the lower limb venous system up to the inferior vena cava. The end point of the study was ultrasound verification of fresh DVT or pulmonary embolism (PE). Verification of PE was made in all cases of DVT using echocardiography, lung scintigraphy, combined single-photon emission computed tomography and X-ray computed tomography, or autopsy. RESULTS: Fresh postoperative DVT was found in 39 patients (28%). The incidence of DVT was 2% in patients with a Caprini score of 5 to 8, 26% in patients with scores of 9 to 11, and 65% in patients with scores of 12 to 15 (P for trend < .01). The risk for DVT was increased 18.7-fold for patients with scores of 9 to 11 and 98.4-fold for scores of 12 to 15 compared with patients with scores of 5 to 8. The area under the receiver operating characteristic curve was 0.87 (95% confidence interval, 0.81-0.94) and a Caprini score of 11 was the cutoff point that provided the highest sensitivity combined with highest specificity. In the 77 patients with a score of <11, DVT occurred in 2 patients (3%). In contrast, in the 63 patients with a score of ≥ 11, DVT occurred in 37 patients (59%; P < .01). PE was found in 13 patients (9%) and confirmed with autopsy. In all cases, verified fresh DVT was the source of embolism. CONCLUSIONS: There was a significant correlation between Caprini scores and the incidence of postoperative DVT in high-risk surgical patients. A Caprini score of ≥ 11 can identify a subgroup of patients at extremely high risk. These patients need a more effective prophylactic regimen.