Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy
2026년 5월 6일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
90
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Qalyubia Governorate
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Banhā, Qalyubia Governorate, 이집트, 13511
- Benha University Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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위약 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in hemoglobin concentration after percutaneous nephrolithotomy
기간: Preoperative, immediate postoperative, and 24 hours postoperative
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Difference in hemoglobin concentration measured before surgery and after surgery to assess perioperative blood loss.
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Preoperative, immediate postoperative, and 24 hours postoperative
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in hematocrit concentration after percutaneous nephrolithotomy
기간: Preoperative, immediate postoperative, and 24 hours postoperative
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Difference in hematocrit concentration measured before surgery and after surgery as an additional indicator of perioperative blood loss.
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Preoperative, immediate postoperative, and 24 hours postoperative
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Need for blood transfusion
기간: Intraoperatively and up to 24 hours postoperatively
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Number of participants who required blood transfusion during the intraoperative or postoperative hospital stay period.
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Intraoperatively and up to 24 hours postoperatively
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Hemoglobin concentration in irrigation fluid
기간: At the end of surgery
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Hemoglobin concentration measured in the irrigation fluid collected at the end of surgery as an estimate of intraoperative blood loss.
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At the end of surgery
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Endoscopic surgical field visibility score
기간: At the end of surgery
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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.
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At the end of surgery
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Postoperative Hematuria
기간: Up to 24 hours postoperatively
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Number of participants who developed visible blood-stained urine after percutaneous nephrolithotomy.
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Up to 24 hours postoperatively
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Need for Additional Hemostatic Intervention
기간: Up to 24 hours postoperatively
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Number of participants who required an additional intervention to control bleeding after percutaneous nephrolithotomy.
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Up to 24 hours postoperatively
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Postoperative Infection
기간: Up to 24 hours postoperatively
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Number of participants who developed postoperative infection after percutaneous nephrolithotomy.
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Up to 24 hours postoperatively
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Postoperative Hematuria
기간: Up to 24 hours postoperatively
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Number of participants with visible hematuria requiring continued nephrostomy tube closure or delayed nephrostomy tube removal.
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Up to 24 hours postoperatively
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 5월 30일
기본 완료 (실제)
2026년 4월 15일
연구 완료 (실제)
2026년 4월 15일
연구 등록 날짜
최초 제출
2026년 5월 6일
QC 기준을 충족하는 최초 제출
2026년 5월 6일
처음 게시됨 (실제)
2026년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 6일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- MS 33-5-2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Data will become available beginning 6 months after publication of the study results and will remain available for 2 years.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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