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。

Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy

2026年5月6日 更新者：Hossam Hassan Mohamed Mandour、Benha University

The Role of Tranexamic Acid Combined Dose Intravenous and in Irrigation Fluid in Optimizing Percutaneous Nephrolithotomy: A Prospective, Randomized, Controlled and Double-blind Study

Percutaneous nephrolithotomy is a minimally invasive surgical procedure used to remove large kidney stones. Although it is an effective treatment, bleeding during and after the procedure remains one of the main concerns and may sometimes require blood transfusion.

Tranexamic acid is a medication that helps reduce bleeding by limiting the breakdown of blood clots. It can be given through a vein and may also be used locally in irrigation fluid during surgery. This study evaluates whether using tranexamic acid by both routes during percutaneous nephrolithotomy can reduce blood loss, improve the clarity of the surgical field during endoscopy, and reduce the need for blood transfusion.

The study included adult patients with kidney stones larger than two centimeters who were suitable for percutaneous nephrolithotomy. Patients were randomly assigned to receive either tranexamic acid through a vein and in the irrigation fluid, or normal saline as a control treatment. Blood loss was assessed using hemoglobin and hematocrit levels before and after surgery, as well as hemoglobin concentration in the irrigation fluid collected at the end of the operation. The surgeon also assessed the clarity of the surgical field using a ten-point visual scale.

The hypothesis of the study is that combined intravenous and local administration of tranexamic acid in irrigation fluid during percutaneous nephrolithotomy reduces blood loss, improves surgical visibility, and lowers the need for blood transfusion compared with normal saline.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

90

段階

  • フェーズ 4

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

  • エジプト
    • Qalyubia Governorate
      • Banhā、Qalyubia Governorate、エジプト、13511
        • Benha University Hospital

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

説明

Inclusion Criteria:

  • Adult patients aged 18 to 70 years.
  • Patients with renal stones larger than 2 centimeters.
  • Patients scheduled for percutaneous nephrolithotomy.
  • Normal renal function, defined as serum creatinine less than or equal to 1.5 milligrams per deciliter.
  • American Society of Anesthesiologists physical status class 1 or 2.

Exclusion Criteria:

  • Hypersensitivity to tranexamic acid.
  • Pregnancy.
  • Current anticoagulation therapy.
  • Untreated urinary tract infection or urosepsis.
  • Renal anatomical anomalies, including ectopic kidney, duplex collecting system, or horseshoe kidney.
  • Solitary functioning kidney.
  • Decompensated coagulopathy or known hematological disease.
  • Acute or chronic renal disease.
  • History of cerebrovascular events or thromboembolism.
  • Uncontrolled arrhythmia.
  • Morbid obesity.

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：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：Combined Tranexamic Acid Group
Participants in this arm received tranexamic acid 10 milligrams per kilogram intravenously in 250 milliliters normal saline 15 minutes before induction of anesthesia, in addition to the same dose of tranexamic acid added to the first 4 liters of irrigation fluid during percutaneous nephrolithotomy.
薬：Tranexamic acid
Tranexamic acid was administered as a combined intravenous and local intervention during percutaneous nephrolithotomy. The intravenous dose was given before anesthesia induction, and the local dose was added to the initial irrigation fluid used during the procedure.
プラセボコンパレーター：Normal Saline Control Group
Participants in this arm received 250 milliliters normal saline intravenously 15 minutes before induction of anesthesia, in addition to normal saline placebo added to the first 4 liters of irrigation fluid during percutaneous nephrolithotomy.
薬：Normal Saline
Normal saline was used as the placebo comparator. It was administered intravenously before anesthesia induction and added to the initial irrigation fluid during percutaneous nephrolithotomy.

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
Change in hemoglobin concentration after percutaneous nephrolithotomy
時間枠：Preoperative, immediate postoperative, and 24 hours postoperative
Difference in hemoglobin concentration measured before surgery and after surgery to assess perioperative blood loss.
Preoperative, immediate postoperative, and 24 hours postoperative

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in hematocrit concentration after percutaneous nephrolithotomy
時間枠：Preoperative, immediate postoperative, and 24 hours postoperative
Difference in hematocrit concentration measured before surgery and after surgery as an additional indicator of perioperative blood loss.
Preoperative, immediate postoperative, and 24 hours postoperative
Need for blood transfusion
時間枠：Intraoperatively and up to 24 hours postoperatively
Number of participants who required blood transfusion during the intraoperative or postoperative hospital stay period.
Intraoperatively and up to 24 hours postoperatively
Hemoglobin concentration in irrigation fluid
時間枠：At the end of surgery
Hemoglobin concentration measured in the irrigation fluid collected at the end of surgery as an estimate of intraoperative blood loss.
At the end of surgery
Endoscopic surgical field visibility score
時間枠：At the end of surgery
Surgical field visibility was assessed by the operating surgeon using a 10-point visual scale. The score ranges from 1 to 10, where 1 indicates very poor visibility and 10 indicates perfect visibility. Higher scores indicate better endoscopic surgical field visibility.
At the end of surgery
Postoperative Hematuria
時間枠：Up to 24 hours postoperatively
Number of participants who developed visible blood-stained urine after percutaneous nephrolithotomy.
Up to 24 hours postoperatively
Need for Additional Hemostatic Intervention
時間枠：Up to 24 hours postoperatively
Number of participants who required an additional intervention to control bleeding after percutaneous nephrolithotomy.
Up to 24 hours postoperatively
Postoperative Infection
時間枠：Up to 24 hours postoperatively
Number of participants who developed postoperative infection after percutaneous nephrolithotomy.
Up to 24 hours postoperatively
Postoperative Hematuria
時間枠：Up to 24 hours postoperatively
Number of participants with visible hematuria requiring continued nephrostomy tube closure or delayed nephrostomy tube removal.
Up to 24 hours postoperatively

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

Benha University

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 (実際)

2025年5月30日

一次修了 (実際)

2026年4月15日

研究の完了 (実際)

2026年4月15日

試験登録日

最初に提出

2026年5月6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

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • MS 33-5-2025

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Deidentified individual participant data related to the study outcomes will be available for sharing. The shared data may include baseline characteristics, operative data, hemoglobin and hematocrit measurements, blood transfusion data, irrigation fluid hemoglobin concentration, surgical field visibility score, and recorded postoperative outcomes.

IPD 共有時間枠

Data will become available beginning 6 months after publication of the study results and will remain available for 2 years.

IPD 共有アクセス基準

Data will be available upon reasonable request from qualified researchers for scientific purposes. Requests will be reviewed by the study investigators, and data will be shared after approval and completion of a data use agreement.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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