Thromboelastography, Platelet Function and Platelet Recovery in Haemato-oncologic Patients With Thrombocytopenia
Monitoring of Thromboelastography, Platelet Function and Platelet Recovery in Haemato-oncologic Patients With Thrombocytopenia
This is a prospective observational clinical study to characterise abnormalities of thromboelastography (TEG) parameters in patients with chemotherapy-induced thrombocytopenia. The investigators are also studying the relationship between Multiplate analysis and bleeding in these patients and the effect of platelet transfusions on thrombopoietin level and percent reticulated platelets.
The investigators' hypothesis is that changes in TEG-parameters reflect the patients tendency to bleed.
調査の概要
詳細な説明
Thrombocytopenic patients are followed with blood samples (thromboelastography, Multiplate, haematology) daily, Monday to Friday for up to 30 days.
In addition bleeding evaluation is done daily ,using a standardized questionnaire. The questionnaire is filled out after interview of the patient, and som times next of kin and nurses. Nurse journals and medical journals are also used to fill in the questionnaires.
For thromboelastography (TEG) we are looking at which parameters are abnormal, and if there is other factors than platelet count that influence the results. We will also compare TEG from days with and without bleeding, to see if they differ.
For Multiplate we are doing a pilot study to see whether this analysis can be of any use at all in this group of patients. We are looking into which factors that influence the Multiplate result, and if we can see a difference in the results if the patient is bleeding.
For reticulated platelets and thrombopoietin we are studying the levels related to platelet transfusions.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Bergen、ノルウェー、5021
- Haukeland University Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
Patients are eligible for this study if:
They have a haemato-oncologic disease They have, or are expected to have, thrombocytopenia They are expected to need at least one platelet transfusion They are aged 18 years or over They consent to participate
Exclusion Criteria:
Patients are not eligible for this study if:
They have a known congenital clotting disorder They need anticoagulants regularly in the study period They have immune thrombocytopenic purpura
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
|---|
|
Hematooncology patients
No intervention
|
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 |
|---|---|---|
|
MA
時間枠：1 year
|
To characterise changes in the TEG-parameter MA in patients with chemotherapy-induced thrombocytopenia
|
1 year
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Reticulated platelets percent
時間枠：1 year
|
To investigate the effect of platelet transfusions on percent reticulated platelets.
|
1 year
|
|
Bleeding
時間枠：1 year
|
To investigate the relationship between TEG-parameters, bleeding and need for platelet transfusion. To investigate the influence of HLA antibodies on risk of bleeding and transfusion complications. |
1 year
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Tor A Hervig, dr.med、University of Bergen
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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