Heparin and the Reduction of Thrombosis (HART) Trial
Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery
연구 개요
상세 설명
Patients are contacted pre-operatively and their parents consented. The following criteria apply:
Inclusion criteria:
All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital
Exclusion Criteria:
Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need for therapeutic heparinization ECMO
Randomization and blinding are performed in the Pharmacy. The intervention is initiated at the intensive care unit physician's discretion, generally within the 1st 24 hours post-operatively. The study is terminated when all catheters have been discontinued or at POD #14, whichever occurs first.
Thrombosis is demonstrated by echocardiogram or ultrasound performed at
1 - 3 days, 5 - 7 days, and 10 - 14 days after initiation of the study drug.
The following are calculations for statistical analysis:
Sample size determination - Using 2 - sided alpha = 0.05 and Beta = 0.2, and assuming a baseline thrombosis incidence of 20%, 160 patients are required to detect an effect size of 15%.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
California
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Stanford, California, 미국, 94305
- Stanford University School of Medicine
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital & #xA
Exclusion Criteria:
- Known coagulopathy
- History of clinically significant bleeding (GI, cranial, pulmonary)
- Need for therapeutic heparinization
- ECMO
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Study drug
Heparin sulfate infusion at 10 units/kg/hour
|
Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery
다른 이름들:
|
|
위약 비교기: Placebo
Placebo - normal saline infusion
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Infusion of normal saline
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Thrombosis
기간: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days
|
Echocardiographic evidence of thrombosis while on study drug
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Total PRBCs Transfused
기간: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
|
Days to Extubation
기간: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
|
Cardiac ICU Length of Stay
기간: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
|
Need for Antibiotics
기간: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Stephen J. Roth M.D., M.P.H., Stanford University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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