このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Prevalence and Risk Factors of Venous Thromboembolism in Hospitalized Pediatric Patients (pediatric DVT)

2017年11月21日 更新者:Penn State University

The issue to be studied is the prevalence of venous thromboembolism (VTE) in hospitalized pediatric patients, and to identify if there are subgroups of patients who may be at higher risk.

There are two hypotheses that will be looked at in this study. The first hypothesis is that individual risk factors for VTE in hospitalized pediatric patients are: age >14, obesity, black race, female sex, presence of a central venous line (CVL), traumatic mechanism of injury, orthopaedic surgery, and use of oral contraceptives.

The second hypothesis is that risk factors have an additive effect such that risk stratification can be developed to identify those patients with the highest risk.

調査の概要

詳細な説明

Venous thromboembolism is a well recognized concern in the hospitalized adult population: 11-15% of medically ill adults will have venous thromboembolism (VTE) and 4-5% will develop a proximal DVT in the absence of prophylaxis.6 Furthermore, these diagnosed events are an underestimation of the prevalence of VTE as 80% are clinically silent.6 VTE risk stratification exists for adult populations and prophylaxis against VTE is standard procedure. While VTE occurs less frequently in pediatric populations, the incidence is on a rise. Vu et al report a significant increase in DVT in 2003 compared to 1997 using data from the Health Care Cost and Utilization Project Kids' Inpatient Database. 2 If one were to extrapolate the known adult risk factors for VTE to children, this rise could be attributed to an increase in childhood obesity ,4 an increase in estrogen-based therapy among teenage girls1, or the increase in pediatric trauma.3 However, few studies have been performed to show if these or other identified adult risk factors are indeed pediatric risk factors as well. Due to this lack of knowledge of risk factors for VTE in pediatric populations, there are minimal guidelines for when physicians should provide prophylactic treatment or even have heightened awareness of the possibility of VTE in their pediatric patient. Furthermore, there are scant published guidelines regarding which type of prophylactic treatment is safe and efficacious in the pediatric population, nor are there guidelines regarding the treatment of established VTE. Outcomes of prophylactic treatment will not be able to be evaluated accurately until the measures are undertaken in patients with identified high risk. Identification of high risk groups and subsequent prevention of VTE is important due to the significant morbidity and mortality associated with VTE. Vu et al report a two-fold increase in in-hospital death in pediatric patients with an identified VTE compared to those without one. This risk was independent of other comorbid conditions.2 Morbidity includes pulmonary embolism, recurrent thrombosis, and postphlebitic syndrome (characterized by swelling, pain, skin indurations and pigmentation caused by incompetent venous valves). Due to the younger age of onset, pediatric patients with these morbidities live with the consequences for a much longer period of time; furthermore, they may experience secondary consequence such as limb length discrepancies, etc.

Currently there is a sharp delineation in prophylaxis strategy as defined merely by age. As soon as a patient is 18 he is assessed by risk stratification models and given prophylaxis if he meets these criteria. A patient just one year younger, however, is left unevaluated due to the lack of criteria for VTE risk in pediatric patients. The patient may fit height and weight averages of a full grown adult, and may possess many of the criteria used to assess an adult for VTE risk. He still may not be offered prophylaxis treatment due to his age alone. This assumes age is the best predictive factor of VTE in the younger patient. However, few studies have been done assessing what risk factors truly exist for the pediatric patient, and those that have, suggest that there are other factors that play into the equation, and may even be more important.5 Due to potential complications from both VTE as well as prophylaxis, and the increasing prevalence of VTE in pediatric populations, studies regarding risk factors and safety/efficacy of prophylactic treatment are needed to establish guidelines of care.

研究の種類

観察的

入学 (実際)

25

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

1ヶ月~18年 (子、大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Patients aged <18 years old, who were hospitalized at MSHMC from January 1, 2000 -December 31, 2008 with documented VTE in one of three databases:

  1. Vascular lab duplex ultrasound database
  2. Inpatient hospital admission/discharge ICD-9 database
  3. PTSF pediatric trauma database

説明

Inclusion Criteria:

  • Age <18
  • Hospitalized for greater than or equal to 24 hours
  • VTE documented during hospital admission

Exclusion Criteria:

  • Age >18

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
hospital pediatric patients 1/1/2000-12/31/2008 documented VTE
Age <18 Hospitalized for greater than or equal to 24 hours VTE documented during hospital admission

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
documented deep vein thrombosis (DVT)
時間枠:1/1/200 - 12/31/2008

Patients aged <18 years old, who were hospitalized at MSHMC from January 1, 2000 -December 31, 2008 with documented VTE in one of three databases:

  1. Vascular lab duplex ultrasound database
  2. Inpatient hospital admission/discharge ICD-9 database
  3. PTSF pediatric trauma database
1/1/200 - 12/31/2008

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

  • Department of Health and Human Services, Centers for Disease Control and Prevention: http://www.cdc.gov/nchs/data/series/sr_23/sr23_024.pdf 2. L.T. Vu, K.K. Nobuhara, and H. Lee et al., Determination of risk factors for deep venous thrombosis in hospitalized children. Journal of Pediatric Surgery 43 (2008), pp 1095-1099. 3. M.S. Vavilala, A.B. Nathens and G.J. Jurkovich et al., Risk factors for venous thromboembolism in pediatric trauma, J Trauma 52 (2002), pp. 922-927 4. National Health and Nutrition Exam Survey (NHANES); Dept of Health and Human Services, Centers for Disease Control and Prevention: http://www.cdc.gov/nccdphp/dnpa/obesity/childhood/prevalence.htm 5. P.D. Stein, F. Kayali and R.E Olson et al. Incidence of venous thromboembolism in infants and children: Data from the National Hospital Discharge Survey, The Journal of Pediatrics 145 (2004), pp 563-565. 6. R. Pendleton, M. Wheeler, and G. Rodgers. Venous Thromboembolism Prevention in the Acutely Ill Medical Patient: A Review of the Literature and Focus on Special Patient Populations, American Journal of Hematology 79 (2005), pp 229-237.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年5月1日

一次修了 (実際)

2010年3月1日

研究の完了 (実際)

2010年3月1日

試験登録日

最初に提出

2010年6月8日

QC基準を満たした最初の提出物

2010年6月8日

最初の投稿 (見積もり)

2010年6月9日

学習記録の更新

投稿された最後の更新 (実際)

2017年11月24日

QC基準を満たした最後の更新が送信されました

2017年11月21日

最終確認日

2010年6月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する