Evaluation of venous thromboembolism prophylaxis protocol in hematopoietic cell transplant patients.

Hematopoietic cell transplant (HCT) recipients are at risk for thromboembolic and bleeding complications. There is limited evidence regarding the optimal approach to managing venous thromboembolism (VTE) prophylaxis in hospitalized patients undergoing HCT. In this retrospective cohort study, we evaluated the incidence of bleeding and VTE events in hospitalized HCT patients who received VTE prophylaxis per our institution's VTE Prophylaxis Protocol (VPP), with either enoxaparin 40 mg subcutaneously daily or heparin 5 000 units subcutaneously twice daily, compared to historical controls who did not receive VTE prophylaxis. The primary outcome was a composite of major bleeding events, clinically relevant non-major bleeding (CRNMB), and minor bleeding. The secondary outcome was a composite of VTE events. A total of 614 patients were evaluated, including 278 prior to and 336 after implementation of VPP. VTE prophylaxis resulted in no difference in bleeding events (15.1% in the pre-VPP group vs. 14.6% in the post-VPP group, p = 0.86) or composite of major and CRNMB events (0.72% vs. 0.30%, p = 0.59). There was a trend toward lower incidence of VTE events in the post-VPP group which did not reach statistical significance (8.6% vs. 6.0%, p = 0.20). We conclude that VTE prophylaxis does not pose additional bleeding risk in HCT patients.

Lee A ，Badgley C ，Lo M ，Banez MT ，Graff L ，Damon L ，Martin T ，Dzundza J ，Wong M ，Olin R ... -  《-》

Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery.

Venous thromboembolism (VTE), which comprises deep vein thrombosis (DVT) and pulmonary embolism (PE), is the leading cause of preventable death in hospitalised people and the third most common cause of mortality in surgical patients. People undergoing bariatric surgery have the additional risk factor of being overweight. Although VTE prophylaxis in surgical patients is well established, the best way to prevent VTE in those undergoing bariatric surgery is less clear. To evaluate the benefits and harms of pharmacological interventions (alone or in combination) on venous thromboembolism and other health outcomes in people undergoing bariatric surgery compared to the same pharmacological intervention administered at a different dose or frequency, the same pharmacological intervention or started at a different time point, another pharmacological intervention, no intervention or placebo. We used standard, extensive Cochrane search methods. The latest search date was 1 November 2021. We included randomised controlled trials (RCTs) and quasi-RCTs in males and females of any age undergoing bariatric surgery comparing pharmacological interventions for VTE (alone or in combination) with the same pharmacological intervention administered at a different dose or frequency, the same pharmacological intervention started at a different time point, a different pharmacological intervention, no treatment or placebo. We used standard Cochrane methods. Our primary outcomes were 1. VTE and 2. major bleeding. Our secondary outcomes were 1. all-cause mortality, 2. VTE-related mortality, 3. PE, 4. DVT, 5. adverse effects and 6. quality of life. We used GRADE to assess certainty of evidence for each outcome. We included seven RCTs with 1045 participants. Data for meta-analysis were available from all participants. Four RCTs (597 participants) compared higher-dose heparin to standard-dose heparin: one of these studies (139 participants) used unfractionated heparin (UFH) and the other three (458 participants) used low-molecular-weight heparin (LMWH). One study compared heparin versus pentasaccharide (198 participants), and one study compared starting heparin before versus after bariatric surgery (100 participants). One study (150 participants) compared combined mechanical and pharmacological (enoxaparin) prophylaxis versus mechanical prophylaxis alone. The duration of the interventions ranged from seven to 15 days, and follow-up ranged from 10 to 180 days. Higher-dose heparin versus standard-dose heparin Compared to standard-dose heparin, higher-dose heparin may result in little or no difference in the risk of VTE (RR 0.55, 95% CI 0.05 to 5.99; 4 studies, 597 participants) or major bleeding (RR 1.19, 95% CI 0.48 to 2.96; I2 = 8%; 4 studies, 597 participants; low-certainty) in people undergoing bariatric surgery. The evidence on all-cause mortality, VTE-related mortality, PE, DVT and adverse events (thrombocytopenia) is uncertain (effect not estimable or very low-certainty evidence). Heparin versus pentasaccharide Heparin compared to a pentasaccharide after bariatric surgery may result in little or no difference in the risk of VTE (RR 0.83, 95% CI 0.19 to 3.61; 1 study, 175 participants) or DVT (RR 0.83, 95% CI 0.19 to 3.61; 1 study, 175 participants). The evidence on major bleeding, PE and mortality is uncertain (effect not estimable or very low-certainty evidence). Heparin started before versus after the surgical procedure Starting prophylaxis with heparin 12 hours before surgery versus after surgery may result in little or no difference in the risk of VTE (RR 0.11, 95% CI 0.01 to 2.01; 1 study, 100 participants) or DVT (RR 0.11, 95% CI 0.01 to 2.01; 1 study, 100 participants). The evidence on major bleeding, all-cause mortality and VTE-related mortality is uncertain (effect not estimable or very low-certainty evidence). We were unable to assess the effect of this intervention on PE or adverse effects, as the study did not measure these outcomes. Combined mechanical and pharmacological prophylaxis versus mechanical prophylaxis alone Combining mechanical and pharmacological prophylaxis (started 12 hours before surgery) may reduce VTE events in people undergoing bariatric surgery compared to mechanical prophylaxis alone (RR 0.05, 95% CI 0.00 to 0.89; number needed to treat for an additional beneficial outcome (NNTB) = 9; 1 study, 150 participants; low-certainty). We were unable to assess the effect of this intervention on major bleeding or morality (effect not estimable), or on PE or adverse events (not measured). No studies measured quality of life. Higher-dose heparin may make little or no difference to venous thromboembolism or major bleeding in people undergoing bariatric surgery when compared to standard-dose heparin. Heparin may make little or no difference to venous thromboembolism in people undergoing bariatric surgery when compared to pentasaccharide. There are inadequate data to draw conclusions about the effects of heparin compared to pentasaccharide on major bleeding. Starting prophylaxis with heparin 12 hours before bariatric surgery may make little or no difference to venous thromboembolism in people undergoing bariatric surgery when compared to starting heparin after bariatric surgery. There are inadequate data to draw conclusions about the effects of heparin started before versus after surgery on major bleeding. Combining mechanical and pharmacological prophylaxis (started 12 hours before surgery) may reduce VTE events in people undergoing bariatric surgery when compared to mechanical prophylaxis alone. No data are available relating to major bleeding. The certainty of the evidence is limited by small sample sizes, few or no events, and risk of bias concerns. Future trials must be sufficiently large to enable analysis of relevant clinical outcomes, and should standardise the time of treatment and follow-up. They should also address the effect of direct oral anticoagulants and antiplatelets, preferably grouping them according to the type of intervention.

Amaral FC ，Baptista-Silva JC ，Nakano LC ，Flumignan RL ... -  《Cochrane Database of Systematic Reviews》

Characterization of direct oral anticoagulants use in adult hematopoietic stem cell transplant recipients.

Yang C ，Khan F ，MacDonald C ，Guglielmo J ，Lo M ，Young R ，Banez MT ，Huang L ，Nguyen R ，Kang S ，Saunders IM ... -  《-》

Venous Thromboembolism Prophylaxis in Low Body Weight Critically Ill Patients.

Knox H ，Edwin SB ，Giuliano C ，Paxton RA ... -  《-》

Anti-xa guided enoxaparin thromboprophylaxis is associated with less thromboembolism than fixed dose dalteparin in trauma patients admitted to intensive care.

Venous Thromboembolism (VTE) is a common, preventable complication in trauma. Low-molecular-weight heparin (LMWH) is recommended for VTE prophylaxis (VTEp). We investigated whether switching from fixed-dose dalteparin to anti-Xa-guided enoxaparin prophylaxis reduces VTE without increasing the risk of bleeding among hospitalized trauma patients. This observational study compared injured patients admitted one year before (pre-P) and after (post-P) implementing a new VTEp protocol. The protocol was introduced as a performance improvement project (subcutaneous enoxaparin 30 mg twice daily), with dose calibration to peak plasma Anti-Xa level measured after the 3rd dose. The primary outcomes were the rate of VTE and bleeding. After protocol implementation (post-P), 305 patients were compared to 350 pre-protocol patients (pre-P). Anti-Xa levels were measured in 83% of post-P and none in the pre-P. 40% had low levels of anti-Xa, suggesting inadequate prophylaxis, and enoxaparin doses were accordingly increased. 51% attained the desired anti-Xa levels, 9% had higher levels, and LMWH doses were subsequently reduced. VTE incidence after protocol implementation decreased from 4 to 1.3% (OR 0.31; 95% CI 0.1-0.9, P = 0.03) without increasing the bleeding rate. The time intervals between two consecutive PE events were significantly longer after protocol implementation. Among TBI patients, the rate of VTE was lower. However, it did not reach statistical significance. 75% of patients with VTE had low anti-Xa levels, while 20% of those with bleeding had high anti-Xa levels. Among adult patients in the trauma ICU, compared to a fixed dose dalteparin, enoxaparin prophylaxis with dose calibration according to peak anti-Xa levels was associated with lower VTE rates without increasing the risk of bleeding. About 40% of patients who received initial enoxaparin doses of 30 mg twice daily had anti-Xa levels suggestive of inadequate prophylaxis. Calibrating LMWH dosing may improve VTEp following traumatic injury.

Kloub A ，Alaieb A ，Kanbar A ，Abumusa S ，Alishaq F ，Hinawi Y ，Khan NA ，Asim M ，Abulkhair T ，El-Menyar A ，Al-Thani H ，Rizoli S ... -  《-》