Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles (MicroTEC)
2017年11月22日 更新者：Jeffrey Zwicker, MD、Beth Israel Deaconess Medical Center
A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles
Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis).
These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening.
The purpose of this research study is to see if enoxaparin is effective in preventing blood clots in the veins in participants who have cancer of the pancreas, colorectal, non-small cell lung, ovary, or gastric and also have high levels of tissue factor bearing microparticles in their blood (TFMP).
TFMP are small particles that are generated from different types of blood cells in the body.
In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis.
Enoxaparin has been used to prevent formation of blood clots in patients after abdominal or orthopedic surgery and in patients who suffer from a severe medical illness.
Based on these studies, we are investigating to see if it prevents thrombosis in people with certain types of cancer.
調査の概要
詳細な説明
The study was a randomized phase II trial to evaluate the cumulative incidence of VTE in cancer outpatients.
At baseline, measurement of tissue factor-bearing microparticles (TFMP) was performed by impedance-based flow cytometry based on established methods.
(Zwicker et al, 2009) Patients were classified as having high or low TFMP levels based on a reference repository of plasmas from sixty cancer patients.
The top tercile of tissue factor-bearing microparticle concentrations from the reference specimens (3.5 x 104 microparticles/µl) was considered a cutoff for "high" and corresponds with previously described "detectable" levels.
Patients with high levels were randomized (2:1) to enoxaparin 40 mg subcutaneously once daily or observation.
Randomization was stratified based on cancer diagnosis.
Low TFMP patients were observed without anticoagulation.
Both the treating physicians and patients were blinded to microparticle status in the observation arms.
研究の種類
介入
入学 (実際)
70
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Los Angeles、California、アメリカ、90033
- University of Southern California-Keck School of Medicine
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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Boston、Massachusetts、アメリカ、02115
- Beth Israel Deaconess Medical Center
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Boston、Massachusetts、アメリカ、02130
- VA Boston Healthcare System
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Danvers、Massachusetts、アメリカ、01923
- Mass General/North Shore Cancer Center
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative therapies do not exist. Eligible malignancies include:
- Adenocarcinoma of the pancreas (locally advanced or metastatic)
- Colorectal (stage IV)
- Non-small cell lung (unresectable stage III or IV)
- Relapsed ovarian or stage IV
- Surgically unresectable or metastatic gastric adenocarcinoma
- First or second line therapy (within 4 weeks of initiating therapy).
- Minimum age 18 years
- Life expectancy of greater than 6 months
- ECOG Performance Status 0, 1, or 2 (Karnofsky 60% or greater).
- Participants must have normal organ and marrow function as outlined in the protocol.
Exclusion Criteria:
- Participants may not be receiving any other study agents.
- Known brain metastases should be excluded from this clinical trial because of their poor prognosis and higher potential for intracranial hemorrhage.
- Prior history of documented venous thromboembolic event or pulmonary embolism within the last 5 years years (excluding central line associated events whereby patients completed anticoagulation > 3 months previously)
- Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)
- Any history of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 5 years
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to enoxaparin or heparin.
- History of heparin-induced thrombocytopenia
- Presence of coagulopathy (PT or PTT> 1.5 x upper limit of normal)
- Familial bleeding diathesis
- Known diagnosis of disseminated intravascular coagulation
- Currently receiving anticoagulant therapy
- Current use of aspirin (>81mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox), or regular use of non-steroidal anti-inflammatory agents more than twice weekly. Maximum dose of ibuprofen is 400mg no more than twice per week.
- Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：High TFMP: Enoxaparin
Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).Only patients with high TFMP status at baseline were randomized to treatment or observation.
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他の名前：
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介入なし：High TFMP: Observation
Patients undergo observation until evaluation with a lower extremity ultrasound at 2 months (day 60).
Only patients with high TFMP status at baseline were randomized to treatment or observation.
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介入なし：Low TFMP: Observation
Patients undergo observation until evaluation with a lower extremity ultrasound at 2 months (day 60).
Patients with low TFMP status at baseline were directly assigned to observation.
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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 |
|---|---|---|
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2-Month Cumulative Incidence of VTE
時間枠：Assessment with lower extremity ultrasound occured at day 60/ month 2
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2-month cumulative incidence of venous thromboembolism (VTE) is the probability of experiencing within 2 months of study entry the following events: any symptomatic proximal or distal lower extremity deep vein thrombosis, symptomatic pulmonary embolism or fatal pulmonary embolism diagnosed by autopsy, or asymptomatic proximal deep vein thrombosis diagnosed by screening compression ultrasound.
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Assessment with lower extremity ultrasound occured at day 60/ month 2
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Major Hemorrhage Events
時間枠：Assessed during the 60 day therapy
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Incidence is the number of patients experiencing at least one major hemorrhage events as defined according to International Society on Thrombosis and Haemostasis (ISTH) guidelines.
(Schulman and Kearon 2005)
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Assessed during the 60 day therapy
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Overall Survival
時間枠：Assessed up to approximately 30 months
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Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.
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Assessed up to approximately 30 months
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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。
協力者
捜査官
- 主任研究者：Jeffrey Zwicker, MD、Beth Israel Deaconess Medical Center
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
- Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
- Zwicker JI, Liebman HA, Bauer KA, Caughey T, Campigotto F, Rosovsky R, Mantha S, Kessler CM, Eneman J, Raghavan V, Lenz HJ, Bullock A, Buchbinder E, Neuberg D, Furie B. Prediction and prevention of thromboembolic events with enoxaparin in cancer patients with elevated tissue factor-bearing microparticles: a randomized-controlled phase II trial (the Microtec study). Br J Haematol. 2013 Feb;160(4):530-7. doi: 10.1111/bjh.12163. Epub 2012 Dec 13.
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)
2012年4月1日
研究の完了 (実際)
2012年10月1日
試験登録日
最初に提出
2009年5月26日
QC基準を満たした最初の提出物
2009年5月26日
最初の投稿 (見積もり)
2009年5月27日
学習記録の更新
投稿された最後の更新 (実際)
2017年12月19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22日
最終確認日
2017年11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。