Platelets and Extracorporeal Membrane Oxygenation Veno-venous (PLAT-VV-ECMO)
2026年5月6日 更新者：University Hospital, Toulouse
Study of PLATelet Functions and Risk Factors for Hemorrhagic Complications in Patients on Extracorporeal Membrane Oxygenation Veno-venous: Prospective Monocentric Cohort
In severe lung or heart disease, ExtraCorporeal Membrane Oxygenation (ECMO) may be used temporarily and can be responsible for major haemorrhagic complications.
Thrombocytopenia and possibly thrombopathy promote bleeding.
The primary objective is to characterize platelet dysfunction by aggregometry tests over time.
Secondarily, investigators seek a correlation between haemorrhagic complications at day 10 and markers of platelet action and dysfunction; also, with the level of anticoagulation and inflammation by biomarkers.
調査の概要
詳細な説明
Despite the frequency of thrombocytopenia in patients on VV-ECMO and its associated haemorrhagic consequences, its predictive factors are still poorly described.
Furthermore, studies suggest the presence of thrombopathy in patients on ECMO, but they are scarce and based on a heterogeneous population with a small sample size, or with vent-arterial (VA) ECMO, mainly after cardiac surgery exposed to a different extracorporeal circulation.
The factors responsible for this thrombopathy and its repercussions are currently unknown.
In contrast to previous studies that focused on platelet functions in patients on ECMO, our study will be the first to analyse specialized platelet functions and thrombo-inflammation in a cohort only with VV-ECMO excluding cardiac surgery patients at risk of thrombopathy.
This work will provide, for the first time, a comprehensive view of the patient on VV-ECMO, ranging from clinical characteristics to the study of platelet activation and functions and thrombo-inflammation analysis and also integrating biological data and ECMO characteristics, all over time.
The procedure will involve collecting blood samples from the patient on VV-ECMO and platelet aggregation tests will be performed, along with measurements of platelet activation markers and a search for leuko-platelet aggregates.
Investigators will evaluate the clinical-biological impact by searching for blood hemolysis, the level of inflammation, coagulopathy and hemorrhagic complications during VV-ECMO support.
The patient's clinical characteristics will be analysed until their discharge from the intensive care unit.
Clinical, biological, ECMO, and specialized haemostasis data will be studied to achieve the study objectives.
研究の種類
観察的
入学 (推定)
40
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。
研究連絡先
- 名前：Baptiste COMPAGNON
- 電話番号：+33 5 61 32 27 99
- メール：compagnon.b@chu-toulouse.fr
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
The study population will be selected from adult patients requiring venovenous ECMO support and admitted to the general intensive care unit of Hôpital Rangueil (Toulouse University Hospital), a regional referral center for ECMO in Occitanie West.
Patients may be transferred from other hospitals in the region or directly managed at Hôpital Rangueil following ECMO implantation.
説明
Inclusion Criteria:
- Adults aged ≥ 18 years
- No objection to participation in the study, obtained from a relative or trusted person; if no relative is available, inclusion under emergency procedure (pending patient or relative non-opposition)
- Patients requiring admission to the general intensive care unit of Hôpital Rangueil for venovenous ECMO
- Equipped with an arterial catheter for blood sampling
- Ability to undergo the 4 blood draws relevant to the study
- Receiving therapeutic anticoagulation with unfractionated heparin
- Enrolled in a social security program or equivalent
- No measures for Limitation and Withdrawal of Therapy have been implemented
Exclusion Criteria:
- Minors
- Patients under court-appointed guardianship or conservatorship
- Pregnant or breastfeeding women
- Hematological disease (leukemia, lymphoma) or constitutional thrombocytopenia
- Platelet transfusion within 7 days prior to enrollment
- Indication for immediate emergency ECMO preventing blood sampling before placement
- Post-cardiotomy
- Patient on antiplatelet therapy
- Severe thrombocytopenia <50 G/L
- Other invasive mechanical support such as Impella®, intra-aortic balloon pump, or Left Ventricular Assist Device (LVAD)
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 |
介入・治療 |
|---|---|
|
patients on Extracorporeal Membrane Oxygenation veno-venous
major patients admitted to the general intensive care unit on Extracorporeal Membrane Oxygenation veno-venous
|
Part of the biology data is used from the patient's routine blood tests.
Additional blood samples are taken from an arterial catheter already in place.
They are performed over 4 periods: one just before start ECMO and 3 under ECMO at 3-day intervals
|
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 |
|---|---|---|
|
Platelet aggregation response over time during venovenous ECMO at baseline
時間枠：T0: Baseline (before ECMO initiation)
|
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
|
T0: Baseline (before ECMO initiation)
|
|
Platelet aggregation response over time during venovenous ECMO at Day 2 of ECMO
時間枠：T1: Day 2 of ECMO
|
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
|
T1: Day 2 of ECMO
|
|
Platelet aggregation response over time during venovenous ECMO at Day 5 of ECMO
時間枠：T2: Day 5 of ECMO
|
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
|
T2: Day 5 of ECMO
|
|
Platelet aggregation response over time during venovenous ECMO at Day 8 of ECMO
時間枠：T3: Day 8 of ECMO
|
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
|
T3: Day 8 of ECMO
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of bleeding event
時間枠：Up to Day 10 of ECMO
|
Numbers of Bleeding event occurring within the first 10 days of VV-ECMO: internal and/or external bleeding that, due to its severity, requires discontinuation of anticoagulation and/or a blood transfusion and/or a surgical or interventional procedure and/or results in a life-threatening condition
|
Up to Day 10 of ECMO
|
|
Platelet activation marker
時間枠：day 8
|
Concentrations of platelet activation markers
|
day 8
|
|
Platelet aggregation intensity
時間枠：day 8
|
Percentage of platelet aggregation intensity measured at the four sampling time points and following stimulation with three platelet agonists (TRAP, CRP, and ADP)
|
day 8
|
|
Leukocyte-platelet aggregate percentage
時間枠：day 8
|
Percentage of leukocyte-platelet aggregates with leukocyte and platelet fluorescent labeling (flow cytometry)
|
day 8
|
|
Systemic anticoagulation level (anti-Xa activity)
時間枠：day 8
|
The level of systemic anticoagulation will be assessed by anti-Xa activity (IU/mL)
|
day 8
|
|
Markers of inflammation-leukocyte
時間枠：day 8
|
Serum concentrations of inflammatory markers including leukocyte count (/mm³)
|
day 8
|
|
Markers of inflammation- CRP
時間枠：day 8
|
Serum concentrations of inflammatory markers including C-reactive protein (CRP, mg/L)
|
day 8
|
|
Markers of inflammation_fibrinogen
時間枠：day 8
|
Serum concentrations of inflammatory markers including fibrinogen (g/L)
|
day 8
|
|
Platelet activation and aggregation parameters
時間枠：Day 8
|
Platelet activation marker concentrations and platelet aggregation intensity percentage, including platelet-leukocyte aggregation percentage
|
Day 8
|
|
Hemolysis parameters-LDH
時間枠：day 8
|
Serum levels of lactate dehydrogenase (LDH, IU/L)
|
day 8
|
|
Hemolysis parameters-free bilirubin
時間枠：day 8
|
Serum levels of and free bilirubin (µmol/L)
|
day 8
|
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。
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 (推定)
2026年5月1日
一次修了 (推定)
2028年12月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年4月27日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月12日
QC基準を満たした最後の更新が送信されました
2026年5月6日
最終確認日
2026年5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。
blood drawsの臨床試験
-
University of UtahAlbert Einstein College of Medicine; University of California, San Francisco; National Human Genome... と他の協力者完了新生児スクリーニング
-
Ischemia Care LLC完了虚血性脳卒中 | 心房細動 | 血栓性脳卒中 | 一過性脳虚血発作 | 心塞栓性脳卒中 | 脳底動脈の脳卒中 | 一過性脳血管イベントアメリカ
-
Applied Science & Performance Institute完了
-
Bedford Hospital NHS TrustAnglia Ruskin Universityわからない