Comparison Between Efficacy of Inhaled VS Intravenous Tranexamic Acid for Hemoptysis
This will be a prospective comparative cohort study and will take place at the Ward II- Ojha Institute of Chest Diseases (OICD) ,Dow University of Health Sciences in Karachi.
It will be conducted over six months after obtaining necessary approvals. We will recruit 154 patients aged 18-60 years, regardless of gender, who will present with complain of hemoptysis. Patients will be selected through a non-probability consecutive sampling method, where each eligible patient will be approached for participation.
Participants will be randomly assigned to one of two groups using a lottery method:
- Group A will receive 500 mg of inhaled Tranexamic acid three times a day.
- Group B will receive 500 mg of intravenous Tranexamic acid three times a day.
Once patients give consent for participation, we will gather detailed medical history. Blood tests and X-rays will be done to assess each patient's health status.
We will then monitor the amount of blood expectorated after 30 minutes, 6 hours, 12 hours, and 24 hours post-administration. We will also observe any side effects from the treatment.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Sindh
-
Karachi、Sindh、パキスタン
- Ward-2 Ojha Institute of Chest Diseases (OICD), Dow University of Health Sciences
-
-
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
説明
Inclusion Criteria:
- Adult patients aged 18-60 years.
- Patients diagnosed with hemoptysis based on the defined operational definition.
- Patients who provide written informed consent to participate in the study.
Exclusion Criteria:
- Patients with known hypersensitivity to Tranexamic acid.
- Hemodynamically unstable patients.
- Patients requiring immediate interventional procedure or mechanical ventilation.
- Patients with active thromboembolic events (pulmonary embolism, deep vein thrombosis, ischemic stroke).
- Patients with a history of thromboembolic disease.
- Patients with disseminated intravascular coagulation (DIC) without heparin.
- Patients with severe renal impairment, gross upper urinary tract hematuria, recent vascular stent/graft, or subarachnoid hemorrhage.
- Pregnant and breastfeeding women.
- Patients who are not willing to participate in the study.
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
- 主な目的：処理
- 割り当て：非ランダム化
- 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 |
|---|---|
|
実験的：Inhaled Tranexamic Acid
|
Tranexamic acid 500 mg administered via inhaled route three times daily or intravenous route three times daily for management of hemoptysis |
|
実験的：Intravenous Tranexamic Acid
|
Tranexamic acid 500 mg administered via inhaled route three times daily or intravenous route three times daily for management of hemoptysis |
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 |
|---|---|---|
|
Significant reduction in hemoptysis
時間枠：2 hours after drug administration
|
Proportion of patients achieving more than 50% reduction in hemoptysis blood volume after administration of Tranexamic Acid. |
2 hours after drug administration
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Amount of hemoptysis reduction
時間枠：30 minutes, 6 hours, 12 hours, and 24 hours after drug administration
|
Change in amount of blood loss due to hemoptysis after treatment. |
30 minutes, 6 hours, 12 hours, and 24 hours after drug administration
|
|
Side effects of Tranexamic Acid
時間枠：Within 24 hours after drug administration
|
Presence of adverse effects after administration of Tranexamic Acid, including redness, burning, pain, swelling, or other reported side effects. |
Within 24 hours after drug administration
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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。