scholarly journals Incidence and Risk Factors for Venous Thromboembolism in Patients with Spinal Cord Injury: A Retrospective Study

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1440-1440
Author(s):  
Siavash Piran ◽  
Sam Schulman

Abstract Introduction: The true incidence of venous thromboembolism (VTE) in patients with acute spinal cord injury (SCI) is unclear. The management of thromboprophylaxis varies among clinicians and is challenging due to the balance against bleeding. There is limited data on the risk factors associated with VTE in patients with an acute SCI. Methods: We performed a retrospective chart review of consecutive adult patients with acute traumatic or non-traumatic SCI presenting within 1 week of injury from 2009 to 2015. We excluded patients who were already on therapeutic oral anticoagulation, those who had a short hospital admission (<7 days), and patients who had early transfer to a different hospital location (<30 days from the initial admission). The primary outcome was incidence of symptomatic, objectively verified deep vein thrombosis (DVT) and/or pulmonary embolism (PE) within 90 days. Secondary outcomes were major bleeding, all-cause mortality, and fatal PE. Step-wise cox modeling analyses were used to identify risk factors for VTE. Results: A total of 211 eligible patients were initially screened and 60 patients were excluded: 34 patients had short hospital admissions, 17 were transferred to a different hospital location (median time of 11 days, range 5 to 29 days), 3 had another reason for admission, and 6 patients were already on therapeutic anticoagulation. The remaining 151 patients with acute SCI were analyzed. Median age was 51 (range 17 to 91 years) and 106 (70%) were males. Patients were followed for a median of 90 days (range 1 to 90 days) and the median length of hospital stay was 79 days (range 1 to 90 days). Hundred and eleven patients (73.5%) had paraplegia or tetraplegia, 10 patients (6.6%) had no neurological impairment, and the degree of impairment was unspecified in 30 patients (19.9%). A total of 112 patients (74.2%) had a traumatic SCI with a fracture, 34 (22.5%) had a traumatic SCI without a fracture, and 5 (3.3%) had a non-traumatic SCI. Ninety four patients (62.2%) had a SCI alone versus 57 (37.8%) who had other sites of injury in addition to a SCI. The median duration of thromboprophylaxis was 65 days (range 2 to 90 days). Majority of the patients (59.6%) received low-dose low-molecular-weight heparin (LMWH) either alone (85 of 151, 56.3%) or sequentially with warfarin (5 of 151, 3.6%) with international normalized ratio range of 2 to 3 compared to 48 patients (31.8%) who received increased intensity LMWH either alone (9 of 151, 6%) or sequentially with low-dose LMWH (39 of 151, 25.8%). Thirteen patients (8.6%) had no thromboprophylaxis. Of the 151 patients included in the analysis, 17 patients (11%) had symptomatic VTE (9 PEs, 6 lower extremity DVT, 1 upper extremity DVT, and 1 with both a DVT and PE). The median time of VTE occurrence was 18 days (range 2 to 65 days) (Figure 1). There was no statistical difference in rate of VTE between the standard prophylactic LMWH group compared to those who received increased intensity LMWH (13.3% versus 8.3%, respectively; odds ratio [OR] 0.59, 95% confidence interval [CI], 0.13-2.1, p = 0.58). Six patients (4%) had major bleeding and none had a fatal PE. The median time of major bleeding occurrence was 17 days (range 8 to 40 days). The all-cause mortality rate was 13.9%. The median time of all-cause death was 6 days (range 1 to 61 days). In the univariate analyses, male sex (OR 14.95; 95% CI, 1.05-49.1, p = 0.003) and having other sites of injuries along with SCI (OR 2.6; 95% CI. 0.8- 8.7, p = 0.049) were significantly associated with the risk of VTE. In stepwise Cox modeling, independent contributors to risk for VTE were other sites of injuries (hazard ratio [HR] 6.07), age (HR 1.05 per year) and to some extent the presence of leg paresis/para- or tetraplegia (HR 2.7), whereas hypertension appeared to reduce the risk (HR 0.18). The gender variable could not be included due to zero events for females. Conclusions: Symptomatic VTE is still today a frequent complication in patients with acute SCI and can occur early after injury. Male sex, age and presence of other sites of injuries along with SCI were independent risk factors for symptomatic VTE. Future randomized trials assessing the role of direct oral anticoagulants versus the current standard of care using low-dose LMWH among these higher risk patients are needed. Figure Survival without symptomatic VTE after SCI Figure. Survival without symptomatic VTE after SCI Disclosures No relevant conflicts of interest to declare.

2019 ◽  
Vol 36 (18) ◽  
pp. 2631-2645 ◽  
Author(s):  
Ashraf S. Gorgey ◽  
Refka E. Khalil ◽  
Ranjodh Gill ◽  
David R. Gater ◽  
Timothy D. Lavis ◽  
...  

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2434-2434
Author(s):  
Siavash Piran ◽  
Michelle Zondag ◽  
Drew Bednar ◽  
Brian Drew ◽  
Agnes Chmiel ◽  
...  

Background: Patients with acute spinal cord injury (SCI) have a high risk of venous thromboembolism despite thromboprophylaxis. Low molecular weight heparin (LMWH), the current standard of care, is inconvenient for long term thromboprophylaxis, costly, and partially effective. Direct oral anticoagulants (DOACs) have been shown to be at least as effective and as safe as LMWH in other thromboprophylaxis settings but there is no randomized evaluation of DOACs in this population. Aim: By conducting a feasibility randomized trial, we aimed to determine the likely recruitment rate of eligible patients into an RCT in which patients with acute SCI were randomized to a prophylactic dose of LMWH or apixaban. Methods: A pilot study was performed at Hamilton General Hospital (HGH). Adult patients with an acute traumatic SCI presenting to the hospital within 1 week of SCI and at least 36 h after the injury were included. Exclusion criteria were the need for therapeutic oral anticoagulation prior to enrolment; active bleeding, intracranial or peri-spinal hematoma, or a bleeding disorder; pregnancy or breastfeeding; severe renal failure (creatinine clearance ≤30 ml/min); severe cirrhosis (Child-Pugh class C); severe thrombocytopenia (platelets <50), unsuitability as determined by the attending physician; geographic inaccessibility; failure to obtain written consent; previous hypersensitivity to study drugs; or expected short hospital admission (≤7 days) due to a minor injury. Eligible patients were randomized to apixaban 2.5 mg twice daily or dalteparin 5000 units once daily for 90 days or until fully mobilized, whatever came first. The primary feasibility outcome was recruitment rate per year. We expected a recruitment rate of 20 patients per year based on an estimated admission rate in a retrospective study at HGH. The primary efficacy outcome was a composite of symptomatic, objectively verified, venous thromboembolism (upper or lower limb deep vein thrombosis (DVT) and/or pulmonary embolism (PE)) or sudden death where PE cannot be excluded. This outcome did not include a catheter-associated DVT. The primary safety end-point was major bleeding. Results: A total of 26 eligible patients were screened and 8 patients were enrolled per year resulting in a recruitment yield of 30.8% (95% confidence interval: 16-50%). The reasons for exclusion included: presence of an epidural hemorrhage (n=8), failure to obtain consent (n=2), not suitable for the study (n=2), >1 week from SCI (n=2), indication for therapeutic anticoagulation (n=2), active bleeding (n=1), and minor injury with an expected short hospital admission (n=1). Four patients were randomized to each drug. Median age was 61 (range 51 to 70) and 7 (87.5%) were males. There were no symptomatic VTE or sudden deaths. One patient randomized to apixaban had major bleeding. There were no serious adverse events. Conclusions: Our pilot study is the first randomized trial to examine the role of a DOAC compared with LMWH for thromboprophylaxis in this high-risk group. The primary feasibility outcome was not met, and therefore a multicenter RCT is unlikely to be feasible. The efficacy and safety of DOACs on this indication should be evaluated in registry- or health care database studies. Disclosures Eikelboom: Heart and Stroke Foundation: Research Funding; Sanofi Aventis: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Glaxo Smith Kline: Honoraria, Research Funding; Eli Lilly: Honoraria, Research Funding; Daiichi Sankyo: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; Boehringer Ingelheim: Honoraria, Research Funding; Bayer: Honoraria, Research Funding; AstraZeneca: Honoraria, Research Funding.


2021 ◽  
Vol 186 (Supplement_1) ◽  
pp. 651-658
Author(s):  
Kath M Bogie ◽  
Steven K Roggenkamp ◽  
Ningzhou Zeng ◽  
Jacinta M Seton ◽  
Katelyn R Schwartz ◽  
...  

ABSTRACT Background Pressure injuries (PrI) are serious complications for many with spinal cord injury (SCI), significantly burdening health care systems, in particular the Veterans Health Administration. Clinical practice guidelines (CPG) provide recommendations. However, many risk factors span multiple domains. Effective prioritization of CPG recommendations has been identified as a need. Bioinformatics facilitates clinical decision support for complex challenges. The Veteran’s Administration Informatics and Computing Infrastructure provides access to electronic health record (EHR) data for all Veterans Health Administration health care encounters. The overall study objective was to expand our prototype structural model of environmental, social, and clinical factors and develop the foundation for resource which will provide weighted systemic insight into PrI risk in veterans with SCI. Methods The SCI PrI Resource (SCI-PIR) includes three integrated modules: (1) the SCIPUDSphere multidomain database of veterans’ EHR data extracted from October 2010 to September 2015 for ICD-9-CM coding consistency together with tissue health profiles, (2) the Spinal Cord Injury Pressure Ulcer and Deep Tissue Injury Ontology (SCIPUDO) developed from the cohort’s free text clinical note (Text Integration Utility) notes, and (3) the clinical user interface for direct SCI-PIR query. Results The SCI-PIR contains relevant EHR data for a study cohort of 36,626 veterans with SCI, representing 10% to 14% of the U.S. population with SCI. Extracted datasets include SCI diagnostics, demographics, comorbidities, rurality, medications, and laboratory tests. Many terminology variations for non-coded input data were found. SCIPUDO facilitates robust information extraction from over six million Text Integration Utility notes annually for the study cohort. Visual widgets in the clinical user interface can be directly populated with SCIPUDO terms, allowing patient-specific query construction. Conclusion The SCI-PIR contains valuable clinical data based on CPG-identified risk factors, providing a basis for personalized PrI risk management following SCI. Understanding the relative impact of risk factors supports PrI management for veterans with SCI. Personalized interactive programs can enhance best practices by decreasing both initial PrI formation and readmission rates due to PrI recurrence for veterans with SCI.


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