Dalteparin vs low-dose unfractionated heparin for prophylaxis against clinically evident venous thromboembolism in acute traumatic spinal cord injury: a retrospective cohort study

Background:

When venous thromboembolism (VTE) includes deep-vein thrombosis (DVT) and pulmonary embolism (PE), patients with acute traumatic spinal cord injury (SCI) have the highest incidence of VTE among all hospitalized groups, with PE the third most common cause of death. Although low–molecular-weight heparin (LMWH) outperforms low-dose unfractionated heparin (LDUH) in other patient populations, the evidence in SCI remains less robust.

Objective:

To determine whether the efficacy for LMWH shown in previous SCI surveillance studies (eg, routine Doppler ultrasound) would translate into real-world effectiveness in which only clinically evident VTE is investigated (ie, after symptoms or signs present).

Methods:

A retrospective cohort study was conducted of 90 patients receiving LMWH dalteparin (5,000 U daily) or LDUH (5,000 U twice daily) for VTE prophylaxis after acute traumatic SCI. The incidence of radiographically confirmed VTE was primarily analyzed, and secondary outcomes included complications of bleeding and heparin-induced thrombocytopenia.

Results:

There was no statistically significant association (p = 0.7054) between the incidence of VTE (7.78% overall) and the type of prophylaxis received (LDUH 3/47 vs dalteparin 4/43). There was no significant differences in complications, location of VTE, and incidence of fatal PE. Paraplegia (as opposed to tetraplegia) was the only risk factor identified for VTE.

Conclusions:

There continues to be an absence of definitive evidence for dalteparin (or other LMWH) over LDUH as the choice for VTE prophylaxis in patients with SCI. Novel approaches to VTE prophylaxis are urgently required for this population, whose risk of fatal PE has not decreased over the last 25 years.     

Spinal Cord Injuries in Children and Adolescents: A Review

Abstract

This introductory review provides an overview of pediatric-onset spinal cord injury, emphasizing unique clinical and epidemiologic features, pathophysiology, medical and musculoskeletal complications, and psychosocial and management issues. Developmental factors influence the approach to bowel and bladder programs, mobility, patient education, and management of complications. Rehabilitation goals must be set for each developmental stage, with the final goal being that of a satisfying and productive adult life.     

Bisphosphonate Use in Acute and Chronic Spinal Cord Injury: A Systematic Review

Background/Objective:

Bone density loss occurs rapidly after traumatic spinal cord injury (SCI) and is associated with low-energy fractures below the level of injury, commonly occurring around the knee. Bisphosphonates have been tested as potential agents to prevent bone loss after SCI, but no guidelines exist for clinical use of bisphosphonates in these patients. The objective of this study was to systematically review and evaluate evidence quality in studies of bisphosphonate use in patients with post-treatment follow-up of sublesional bone mineral density.

Methods:

Literature search in MEDLINE/PubMed and ISI database using key words bisphosphonates, spinal cord injury, quadriplegia, paraplegia, and tetraplegia.

Results:

The search identified 6 experimental studies and 1 quasi-experimental study of bisphosphonate therapy in patients with acute and chronic SCI. The studies were small and of fair or poor quality, and none included fracture outcomes. Mild attenuation of bone density loss with acute administration of bisphosphonates after SCI was found at some measurement sites but was not always maintained during follow-up.

Conclusions:

Data were insufficient to recommend routine use of bisphosphonates for fracture prevention in these patients. Current studies are limited by heterogeneity of patient populations and outcome measures. Uniform bone density measurement sites with rigorous quality control and compliance monitoring are needed to improve reliability of outcomes. Future studies should address specific populations (acute or chronic SCI) and should assess fracture outcomes.     

Bisphosphonate Use in Acute and Chronic Spinal Cord Injury: A Systematic Review

Background/Objective: Bone density loss occurs rapidly after traumatic spinal cord injury (SCI) and is associated with low-energy fractures below the level of injury, commonly occurring around the knee. Bisphosphonates have been tested as potential agents to prevent bone loss after SCI, but no guidelines exist for clinical use of bisphosphonates in these patients. The objective of this study was to systematically review and evaluate evidence quality in studies of bisphosphonate use in patients with post-treatment follow-up of sublesional bone mineral density.

Methods: Literature search in MEDLINE/PubMed and ISI database using key words bisphosphonates, spinal cord injury, quadriplegia, paraplegia, and tetraplegia.

Results: The search identified 6 experimental studies and 1 quasi-experimental study of bisphosphonate therapy in patients with acute and chronic SCI. The studies were small and of fair or poor quality, and none included fracture outcomes. Mild attenuation of bone density loss with acute administration of bisphosphonates after SCI was found at some measurement sites but was not always maintained during follow-up.

Conclusions: Data were insufficient to recommend routine use of bisphosphonates for fracture prevention in these patients. Current studies are limited by heterogeneity of patient populations and outcome measures. Uniform bone density measurement sites with rigorous quality control and compliance monitoring are needed to improve reliability of outcomes. Future studies should address specific populations (acute or chronic SCI) and should assess fracture outcomes.     

Efficacy of a New Rehabilitative Device for Individuals With Spinal Cord Injury

Background/Objective:     

Shoulder Muscular Demand During Lever-Activated Vs Pushrim Wheelchair Propulsion in Persons With Spinal Cord Injury

Background/Objective:     

A Simplified Pharmacologic Erection Program for Patients with Spinal Cord Injury

Abstract

Introduction and objectives: Intracavernosal injection (ICI) of vasoactive agents has been successfully used in the treatment of erectile dysfunction (ED). The authors’ pharmacologic erection program, using a fixed combination of prostaglandin El (PGE1) and papaverine, is notable for its simplicity and acceptance by patients who have suffered spinal cord injuries (SCIs).

Methods: Patients undergo baseline questionnaire, physical examination, and hormone profile followed by instruction and injection of a fixed combination of PGE1 and papaverine. On successive visits, the patient injects himself and the dosage is titrated until a satisfactory erection is obtained. Patients who do not respond to injection of 1.0 cc are considered treatment failures. Patients return periodically for routine follow-up.

Results: From May 1994 to March 1997, 37 patients with SCI underwent initial evaluation and 28 (76%) responded to injection therapy and were successfully using self-injection therapy at 3-month follow-up. Twenty-three patients are still on injection therapy. Five patients have dropped out for several reasons including a lack of a current sexual partner (60%) and pain with injection (40%). Patient age ranges from 24 to 72. The dosage range was 0.10 to 0.50 cc (mean = 0.29 cc). The average duration of erection was 43 minutes. At 3-month follow-up, 85% of the patients rated their erections as good or excellent. Forty-three percent of patients are using ICI 1 or more times per week. Seventy-seven percent of patients are moderately or extremely satisfied with their treatment and 89% said that they would recommend this program to a friend.

Conclusions: This simplified pharmacologic erection program offers safe, well accepted, and effective therapy for ED to a SCI population with very high patient satisfaction.     

Surveillance With Duplex Ultrasound In Traumatic Spinal Cord Injury On Initial Admission To Rehabilitation

Abstract

Objective: To determine the prevalence of deep vein thrombosis (DVT) by surveillance duplex ultrasound in the traumatic spinal cord injury (SCI) population on admission to rehabilitation.

Design: Retrospective sequential case series.

Setting: Midwest regional, university-based, Commission on Accreditation of Rehabilitation Facilities-accredited acute rehabilitation center.

Methods: Charts of all patients with traumatic SCI admitted and discharged from january 1, 1996 through December 31, 1998 were reviewed. Preadmission data were collected on demographics, severity of injury, and DVT prophylaxis information, along with rehabilitation duplex ultrasound results and incidence of thromboembolic events.

Results: Ninety-two participants met the inclusion criteria. There were 68 men and 24 women with a mean age on admission of 3 2.4 years. On admission, 45 participants (49%) were classified as tetraplegic and 47 (51%) were classified as paraplegic; 63 (69%) had motor-complete lesions and 29 (31 %) had motor-incomplete lesions. Of all the participants, 8 (8.7%) were found to have DVT on admission to rehabilitation. There were no statistically significant differences among participants with regard to age, sex, level of injury, or completeness of injury, when comparing those participants with DVT on admission, those without DVT on admission, and those with thromboembolic events diagnosed later in their hospitalization. Of the 84 participants who had negative duplex ultrasounds on admission, 4 individuals (4.8%) were found to have DVT and 4 (4.8%) had pulmonary emboli subsequently. In these 84 participants, DVT prophylaxis with low-molecular-weight heparin was found to be more effective than was adjusted-dose heparin in preventing thromboembolic phenomenon.

Conclusion: Incidence of DVT remains high despite prophylaxis in traumatic SCI patients. Two thirds of DVT diagnosed in rehabilitation was identified on admission and one third was diagnosed later. Duplex ultrasound is an effective and valuable tool that assists in the diagnosis of asymptomatic DVT in patients with traumatic SCI who are initiating in -patient rehabilitation.     

Evaluation of the Effects of Compression Stockings Using Venous Plethysmography in Persons With Spinal Cord Injury

Abstract

Background/Objective: To examine the effect of graduated compression stockings (GCS) on the properties of the venous vascular system, as characterized by venous capacitance (VC) and venous outflow (VO), in the lower extremities of individuals with spinal cord injury (SCI), according to injury level.

Methods: Nine male subjects with SCI (5 with low paraplegia [LP], 4 with high paraplegia [HP]) performed 2 plethysmography tests: with and without graduated compression knee-length stockings (pressure of 21 mm/Hg). The VC, VO, and cardiovascular parameters (heart rate and blood pressure) were evaluated with and without GCS.

Results: The VC and VO were lower in patients with HP than in those with LP. For all subjects, VC was significantly lower (-14%) with GCS than without (1.77 ± 1.18 vs 1.53 ± 1.09 vol%, P < 0.01). On the contrary, VO did not differ significantly when wearing or not wearing GCS.

Conclusions: This study demonstrated that 21-mm/Hg knee-length GCS are sufficient to prevent venous distension in individuals with SCI, even those with longstanding paraplegia, by significantly decreasing venous capacitance. This intervention may help to prevent deep vein thrombosis.     

Physical Activity and Quality of Life in Adults With Spinal Cord Injury

Background/Objective: To document the relationship between level of physical activity and quality of life in persons with spinal cord injury.

Design: Cross-sectional investigation.

Participants/Methods: Men (n = 32) and women (n = 30) with complete and incomplete spinal cord lesions below C6 volunteered to participate in this study. The average length of time since the onset of disability was 9 years (range, 1.5-40 years). Using an interview-formatted survey (Quality of Well-Being Scale), a measure of quality of life was obtained for each participant. Physical activity levels were determined using the Physical Activity Scale for Individuals with Physical Disabilities.

Results: A strong positive association (r= 0.75; P < 0.05) was observed between level of physical activity and quality of life. Multiple regression analysis also showed that when level of physical activity, anatomical location of the injury, completeness of injury, and time since injury were used as explanatory variables, level of physical activity was the only significant predictor of quality of life, accounting for 56% of the total variation in quality of life.

Conclusions: Results from this study show that a significant and moderately strong positive relationship exists between level of physical activity and quality of life in adults with spinal cord injury. From a clinical perspective, these findings suggest that interventions aimed at promoting physical activity may be effective in improving quality of life in this population.     

A Placebo-Controlled,Multicenter, Randomized,Double-Blind,Flexible-Dose,Two-Way Crossover Study to Evaluate the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction

Background/objective: To show the efficacy, safety, and tolerability of sildenafil in men with erectile dysfunction (ED) associated with complete or incomplete spinal cord injury (SCI) and to assess its effects onquality of life (Qol) using the Life-Satisfaction Check List.

Methods: This was a placebo-controlled, multicenter, randomized, double-blind, flexible-dose, 2-way crossover study with a 2-week washout period between each phase. Patients with ED attributable to SCI(Sexual Health Inventory-Male score ≤21) received 50 to 100 mg sildenafil (n = 24) or placebo (n = 26).

Results: Compared with placebo, sildenafil produced higher levels of successful sexual stimulation,intercourse success, satisfaction with sexual life and sexual relationship, erectile function, overall sexual satisfaction, and an improved Erectile Dysfunction Inventory of Treatment Satisfaction score, with no clinically relevant effects onvital signs. Sildenafil seemed more effective in patients with incomplete SCI than in those with complete SCI, producing significant improvements, compared with placebo, in a number of measures only in patients with incomplete SCI. All patients who expressed a preference selected sildenafil over placebo, although the drug had no effect on patient Qol. Sildenafil was well tolerated, with a profile comparable to that of placebo.

Conclusions: Compared with placebo, treatment with oral sildenafil safelyand effectively improved erectile function in patients with ED attributable to SCI, especially in those with incomplete injury, and was theagent of choice in those who expressed a preference.     

A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Flexible-Dose, Two-Way Crossover Study to Evaluate the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction

Background/Objective:     

Influenza Vaccination Among Veterans With Spinal Cord Injury: Part 1. A Survey Of Attitudes And Behavior

Abstract

Background/Objective: Persons with spinal cord injury and disorders (SCID) are at increased risk of developing influenza, pneumonia, and ensuing complications. Influenza vaccine has been shown to be effective, yet vaccination rates have been low in this population. To improve these rates, barriers and facilitators to receiving influenza vaccine in this population were identified.

Methods: A cross-sectional telephone survey was conducted with a convenience sample of patients at 1 3 Department of Veterans Affairs (VA) Spinal Cord Injury (SCI) Centers between September and November 2000. Survey questions assessed perceptions regarding the influenza vaccine.

Results: Participants interviewed (N = 377) had a mean age of 5 8.6 years and were predominantly male and white. Most had had received the influenza vaccine at some time in the past; however, 3 5% had not received it in the previous year. The most common reason reported for not being vaccinated was the belief that it was not important. Those who knew the best time to be vaccinated were more likely to have been vaccinated the previous year (OR = 3.57, 9 5%, Cl: 2.1 2-6.01 ). Other predictors of vaccination included being married, being aged 65 and older, and being aware that the vaccine was a good way to prevent some pulmonary problems that can result from influenza.

Conclusions: Barriers to vaccination include poor understanding of the seriousness of influenza and of the vulnerability of someone with SCID to respiratory complications. Availability of the influenza vaccine at VA facilities and knowledge of when to be vaccinated were facilitators. Providers should use every opportunity to vaccinate patients and provide education about the value of influenza vaccination and when to be vaccinated.     

Influenza Vaccination Among Veterans With Spinal Cord Injury: Part 2. Increasing Vaccination Rates

Abstract

Background/Objective: Respiratory complications are the leading cause of morbidity and mortality among individuals with spinal cord injury (SCI). Influenza vaccination is effective in reducing the likelihood of contracting influenza and of subsequent respiratory complications, hospitalizations, and deaths. Historically, vaccination rates for veterans with SCI treated in Veterans Affairs (VA) facilities have been low. The objective of this study was to increase vaccination rates in this population using a multi pronged strategy.

Methods: A quasi-experimental design involving 2,2 84 veterans treated at 8 VA SCI Centers was used. Patients at 4 centers received reminder letters and educational materials tailored to SCI. Provider education included mailed reminders and posters in SCI clinical areas. Clinical champions were identified at each site. Four other centers, matched to the study sites in program size and prior vaccination rates, served as comparison sites providing usual care. Vaccination rates were assessed using mailed surveys with telephone follow-up.

Results: The influenza vaccination rate was significantly higher in the intervention group than in the comparison group (60.5% vs 54.3%; P = 0.01). Vaccine recipients were older than nonrecipients (mean age 60.8 vs 53.1 years; P < 0.0001). Reasons for not receiving a vaccination included refusal, feeling that being vaccinated was not worth the trouble, and not believing that the vaccine would prevent influenza.

Conclusions: Use of low-cost mailed reminders and educational materials resulted in significantly higher vaccination rates. Further efforts to reach targeted subgroups of nonrecipients, such as patients who are younger or from an ethnic minority, are warranted.     

Vitamin B12 Deficiency In Spinal Cord Injury: A Retrospective Study

Abstract

Background/Objective: Vitamin B12 (or cobalamin) deficiency is well known in geriatric patients, but not in those with spinal cord injury (SCI) . This retrospective study describes vitamin B1 2 deficiency in SCI.

Methods: This study utilized a retrospective chart review of patients with SCI who had received serum vitamin B1 2 testing over the last 1 0 years.

Results: Probable vitamin B1 2 deficiency was noted in 1 6 patients with SCI. Twelve patients had subnormal serum vitamin B12 levels (< 220 pg/ml), whereas 4 patients had low-normal vitamin B12 levels (< 300 pg/ml) with neurologic and/or psychiatric symptoms that improved following vitamin B1 2 replacement. Classic findings of paresthesias and numbness often were not evident; such findings likely were masked by the pre-existing sensory impairment caused by SCI. Of the 1 6 SCI patients, 7 were ambulatory; 4 of the 7 presented with deterioration of gait. In addition, 3 of the 1 6 SCI patients presented with depression and fatigue, 2 had worsening pain , 2 had worsening upper limb weakness, and 2 had memory decline. Of the 1 2 patients with subnormal serum vitamin B12 levels, 6 were asymptomatic. Classic laboratory findings of low serum vitamin B1 2 , macrocytic red blood cell indices, and megaloblastic anemia were not always present. Anem ia was identified in 7 of the 1 6 patients and macrocytic red blood cells were found in 3 of the 1 6 patients. Only 1 of the 1 6 SCI patients had a clear pathophysiologic mechanism to explain the vitamin B12 deficiency (ie, partial gastrectomy); none of the patients were vegetarian. Twelve of the SCI patients appeared to experience clinical benefits from cyanocobalamin replacement (some patients experienced more than 1 benefit), including reversal of anemia (5 patients), improved gait (4 patients), improved mood (3 patients), improved memory (2 patients), reduced pain (2 patients) , strength gain (1 patient), and reduced numbness (1 patient).

Conclusion: It is recommended that physicians consider vitamin B1 2 deficiency in their patients with SCI , particularly in those with neurologic and/ or psychiatric symptoms. These symptoms often are reversible iftreatment is initiated early.     

Aging After Spinal Cord Injury: A 30-Year Longitudinal Study

Abstract

Background/Objective: This longitudinal study investigated changes in life satisfaction, general health, activities, and adjustment over 3 decades among individuals with spinal cord injury (SCI).

Participants: The cohort of participants was identified from outpatient records of a large Midwestern United States university hospital. In 1973, 256 individuals completed an initial survey. There were 5 subsequent follow-up surveys, with the most recent being in 2002. Seventy-eight participants completed materials on all 6 occasions.

Methods: The Life Situation Questionnaire was used to identify changes over the 30-year period in 6 areas of life satisfaction, self-rated adjustment (current and predicted), employment status, activities, and medical treatments.

Analyses: These analyses used data from 3 points in time, separated by approximately 15-year intervals. One-way analysis of variance with repeated measures was used to identify changes in outcomes between 1973, 1988, and 2002 for all continuous variables.

Results: We found a mixed pattern of changes over the 30 years, with increases noted during the first 15- year period in sitting tolerance, educational and employment outcomes, satisfaction with employment, and adjustment. Although these changes tended to remain stable during the last 15 years, subtle declines were suggested in some areas, with clear declines noted in terms of diminished sitting tolerance, an increase in the number of physician visits, and decreased satisfaction with social life and sex life.

Conclusions: The results suggest that many positive changes occur within the first 2 decades after SCI, followed by a period of stability in some life areas, but decline with aging in some participation and health-related aspects of life.     

Clinical Assessment and Management of Obesity in Individuals With Spinal Cord Injury: A Review

Background: Diagnosing and managing obesity in individuals with spinal cord injury (SCI) remain challenging.

Methods: Literature on the epidemiology, impact, and management of obesity in individuals with SCI was reviewed.

Findings: Although nearly 66% of individuals with SCI are either overweight or obese, little guidance is available to measure and monitor obesity in the clinical setting. The use of anthropometric indices and specific cut points available for able-bodied persons is limited by the body composition changes that follow SCI. Indices of upper body obesity warrant examination in SCI because they provide an index of central obesity, which is more closely linked to some obesity-related conditions than is overall obesity. Investigations into the sequelae of excess body fat and its distribution are also needed in SCI because past research in this area has been inconclusive. Although limited, evidence regarding obesity interventions in SCI may be promising.

Conclusions: The best anthropometric tool to define obesity in the clinical setting remains unknown. SCI-specific assessment tools and a better understanding of the sequelae of excess body weight will lead to better targeting of prevention and treatment efforts. More research is needed on the individual components of a weight management program unique to SCI. Until then, providers are urged to use a team approach and draw on existing resources and applicable research in able-bodied individuals to facilitate weight management in individuals with SCI.     

Prevention of Venous Thromboembolism in Patients with Spinal Cord Injury: Effects of Sequential Pneumatic Compression and Heparin

Abstract

Objective: To estimate the incidence of and risk factors for venous thromboembolism in patients with acute traumatic spinal cord injury (SCI) and evaluate the effectiveness of sequential pneumatic compression devices (SCD), gradient elastic stockings (GES), and heparin in preventing thromboembolism. Design: Prentice’s case-cohort design.

Setting: All patients admitted to our hospital between 1976 and 1995 with acute traumatic SCI. Main outcome measures: Demographic characteristics, venous thromboembolism risk factors, methods of surveillance and prophylaxis, and thromboembolic events during the first 6 weeks following injury. Results: Venous thromboembolism occurred in 84 of 428 patients (19.6%). Venous thromboembolism increased from 21% between 1976 and 1979 to 31% between 1980 and 1984, then decreased to 16% between 1985 and 1989 and to 8% between 1990 and 1995. Routine surveillance for venous thromboembolism increased through 1983, and SCD/GES use increased after 1983, with a concurrent decline in incidence of thromboembolism. Multivariate analysis showed that SCD/GES reduced the risk of deep venous thrombosis (DVT) or pulmonary embolism (relative risk, 0.5; 95% CI, 0.28 to 0.90). Multivariate analysis suggested a reduced risk of DVT in patients receiving heparin therapy within the first 14 to 42 days after injury, but estimates of reduced risk were not statistically significant (p = .064 for first 14 days, p = .13 for heparin anytime).

Conclusion: The SCD/GES combination and heparin are each effective in preventing venous thromboembolism in individuals’ acute traumatic SCI. Effectiveness of heparin prophylaxis may be greatest during the first 14 days after injury, whereas benefit from SCD continues to 6 weeks after injury.