[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemolysis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemolysis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,53,82,105,129,152],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100641858","early-vs-late-tourniquet-release-and-phlebotomy-induced-hemolysis-in-the-emergency-department-tourni-ed-100641858",false,"NCT07617103","Early vs. Late Tourniquet Release and Phlebotomy-Induced Hemolysis in the Emergency Department: TOURNI-ED","Early Versus Late Release of Sphygmomanometer-Applied Venous Stasis and Phlebotomy-Induced Hemolysis in the Emergency Department: A Parallel-Group Randomized Controlled Trial","TOURNI-ED","Inclusion Criteria:\n\n* Age 18 years or older\n* Presenting to the emergency department and triaged as green (semi-urgent) or yellow (urgent) category according to the Emergency Severity Index (ESI) or equivalent institutional triage system\n* Blood collection (venipuncture) indicated as part of routine clinical care by the attending emergency physician\n* Ability to provide written informed consent\n* Accessible antecubital or forearm vein suitable for standard venipuncture (not requiring intravenous catheter placement for blood collection)\n\nExclusion Criteria:\n\n* Blood collection performed via an existing intravenous catheter or central venous access device\n* Known or suspected coagulation disorder (e.g., hemophilia, thrombocytopenia with platelet count \\\u003C50,000\u002FuL, current anticoagulant therapy with active bleeding)\n* Active upper extremity injury, infection, lymphedema, or arteriovenous fistula at the potential collection site\n* Triage category red (resuscitation) at the time of blood collection\n* Declined informed consent\n* Previously enrolled in this study (re-enrollment not permitted)\n* Pregnancy (due to potential vascular changes affecting hemolysis rate)\n* Known hemolytic anemia or other hematological condition associated with baseline elevated hemolysis","ALL","18 Years",{"count":20,"type":21},792,"ESTIMATED","INTERVENTIONAL",[24],"NA","BACKGROUND:\n\nHemolysis is the most common preanalytical error in emergency department (ED) laboratories, affecting 17-26% of blood samples collected in the ED and leading to test cancellations, repeat venipuncture, delayed diagnoses, and increased healthcare costs. Venous stasis created by tourniquet application during phlebotomy is a recognized contributing factor to hemolysis. While clinical guidelines recommend releasing the tourniquet once blood flow is established, the optimal timing of tourniquet release in relation to tube filling sequence has not been systematically evaluated.\n\nOBJECTIVE:\n\nThe primary objective of this trial is to determine whether early release of sphygmomanometer-applied venous stasis (released after the first tube fills) reduces hemolysis rates compared to late release (released after the last tube fills) during routine phlebotomy in ED patients triaged as green or yellow category.\n\nDESIGN:\n\nSingle-center, parallel-group, superiority randomized controlled trial with 1:1 allocation ratio. The trial was prospectively registered prior to the enrollment of the first participant.\n\nPARTICIPANTS:\n\nAdult patients (≥18 years) presenting to the emergency department with triage category green (semi-urgent) or yellow (urgent), for whom blood collection is indicated as part of routine clinical care. Patients requiring blood collection from an intravenous catheter, those with known coagulation disorders, and those who decline to participate are excluded.\n\nINTERVENTIONS:\n\nGroup A (Early Release): Sphygmomanometer inflated to 60 mmHg for venous stasis; tourniquet released immediately after the first tube (sodium citrate, blue cap) completes filling. Remaining tubes (SST\u002Fgel, yellow cap; K2-EDTA, purple cap) are collected after release.\n\nGroup B (Late Release): Sphygmomanometer inflated to 60 mmHg; tourniquet maintained throughout all tube filling and released only after the last tube (K2-EDTA, purple cap) completes filling. Tube collection order follows the CLSI H03-A6 standard for both groups.\n\nPRIMARY OUTCOME:\n\nHemolysis rate, defined as the proportion of serum separator tube (SST\u002Fyellow cap) samples with a Hemolysis Index (HI) ≥ 1+ (corresponding to free hemoglobin ≥50 mg\u002FdL), is assessed by the clinical chemistry laboratory analyzer. The outcome assessor (laboratory technician) is blinded to group assignment.\n\nSECONDARY OUTCOMES:\n\n(1) Distribution of ordinal hemolysis index categories (-, 1+, 2+, 3+, 4+, 5+) in SST samples; (2) Proportion of hemolyzed samples requiring repeat blood collection; (3) Total blood collection duration (seconds) from sphygmomanometer inflation to last tube filling completion; (4) Complication rate (hematoma, nerve injury, vasovagal reaction, arterial puncture, multiple puncture attempts).\n\nSAMPLE SIZE:\n\nA total of 792 participants (396 per group) are required based on an assumed hemolysis rate of 12% in the late release group and 6% in the early release group (50% relative risk reduction), α=0.05 (two-tailed), 80% power (Fleiss with pooled variance), plus 10% dropout buffer.\n\nRANDOMIZATION:\n\nSimple randomization using a computer-generated random number list (randomizer.org). The allocation sequence is maintained by a designated person not involved in enrollment or data collection. Allocation is revealed sequentially at the point of care.\n\nSTATISTICAL ANALYSIS:\n\nPrimary analysis: Chi-square test comparing hemolysis rates between groups (intention-to-treat population). Secondary analyses: Mann-Whitney U test for ordinal HI distribution; logistic regression for adjusted odds ratio. Bonferroni correction applied to multiple secondary comparisons (adjusted α = 0.017). Per-protocol analysis performed as a sensitivity analysis. Missing data handled using complete case analysis with sensitivity analysis.",[27,28,29,30],"Hemolysis","Blood Specimen Collection","Phlebotomy","Venous Stasis",[32,33,34,35,36,37,38,39],"hemolysis","phlebotomy","tourniquet","venous stasis","emergency department","blood collection","hemolysis index","randomized controlled trial","NOT_YET_RECRUITING","2026-06-13",{"date":43,"type":44},"2026-06-16","ACTUAL",{"date":46,"type":21},"2026-06",{"date":48,"type":21},"2027-08",{"name":50,"class":51},"Marmara University Pendik Training and Research Hospital","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":52},"100619474","feasibility-performance-study-of-abl90-flex-plus-hem-100619474","NCT07345091","Feasibility Performance Study of ABL90 FLEX PLUS HEM","Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM","ABL90FLEXHEM","Inclusion Criteria:\n\n* Subject must be 18 years of age or older\n* Informed consent is obtained:\n\n  * Directly from the subject, if they are competent and able to understand the provided information and voluntarily agree to participate, or\n  * If the subject is temporarily incapacitated and unable to provide informed consent at the time of sample collection, written informed consent will be obtained from the subject's legally designated representative (LDR). when the subject regains capacity after enrollment, they will be informed of study inclusion and given the opportunity to withdraw consent.\n* Subject evaluated as suitable according to the protocol and for the study by the principal investigator or designee.\n\nExclusion Criteria:\n\n* Subject where sample collection is evaluated by PI or designee to impose unnecessary risk.\n* Subject with an invalid written informed consent or who has withdrawn consent.\n* Subject with known pregnancy or who is breastfeeding.",{"count":62,"type":21},95,"OBSERVATIONAL","This feasibility performance study evaluates the ABL90 FLEX PLUS HEM device for its analytical performance in a clinical setting. The study aims to evaluate the performance of the hemolysis detection feature.",[27],[67,68,69,70],"IVDR","Blood Gas Analyser","In vitro diagnostic","hemolysis detection","RECRUITING","2026-01-07",{"date":74,"type":44},"2026-01-15",{"date":76,"type":44},"2025-08-04",{"date":78,"type":21},"2026-06-10",{"name":80,"class":81},"Radiometer Medical ApS","INDUSTRY",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":52},"100571530","modeling-blood-management-and-hemolytic-risk-in-pediatric-heart-surgery-100571530","NCT06721455","Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery","Mathematical Modeling of Salvaged Red Blood Cells-based Blood Management Strategy and Their Hemolytic Risk in Pediatric Cardiac Surgery","Inclusion Criteria:\n\n* pediatric patients under 18 years of age undergoing cardiac surgery with clear prime on cardio-pulmonary bypass (CPB) at Boston Children's Hospital (BCH).\n\nExclusion Criteria:\n\n* patients with known hemolytic disorders, patients on nitric oxide preoperatively, and patients found to have abnormal coagulation on routine preoperative assessment. Patients receiving heparin, American Society of Anesthesia (ASA) status, apixaban, warfarin, or bivalirudin held appropriately (i.e. for elective surgery) will not be excluded","0 Years","17 Years",{"count":92,"type":21},50,"This study aims to learn more about blood management in children undergoing heart surgery, such as the right amounts, and the best blood products, to administer. It also aims to develop a mathematical model that may help researchers better predict and treat patients who need blood transfusions during heart surgery.",[95,96,27],"Heart Surgery","Blood Transfusion","2026-01-05",{"date":72,"type":44},{"date":100,"type":44},"2025-08-01",{"date":102,"type":21},"2026-12-31",{"name":104,"class":51},"Boston Children's Hospital",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":125,"leadSponsor":127,"locationsCount":52},"100542954","optimizing-pulsatility-during-cardiopulmonary-bypass-to-reduce-acute-kidney-injury-100542954","NCT06349577","Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury","Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial","Inclusion Criteria:\n\n* Able to provide informed consent\n* Scheduled for elective cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria\n\n* Emergency procedures\n* Scheduled for heart or lung transplantation\n* Scheduled for ventricular assist device implantation\n* Use of the Medtronic Elongated Once-Piece Arterial Cannula\n* Diagnosed with sepsis\n* Diagnosed with delirium\n* Experiencing hemodynamic instability (heart rate \\> 100 and systolic blood pressure \\\u003C 90)\n* Requiring mechanical circulatory support\n* Requiring vasoactive medications","85 Years",{"count":114,"type":21},1100,[24],"The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass.",[118,27,119,120],"Acute Kidney Injury","Thrombocytopenia","Surgery","2025-05-19",{"date":123,"type":44},"2025-05-21",{"date":121,"type":44},{"date":126,"type":21},"2028-10",{"name":128,"class":51},"University of Colorado, Denver",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":136,"maxAge":90,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":52},"100582323","ventilatory-functions-and-physical-intolerance-in-esrd-adolescents-response-to-program-of-walking-with-dogs-100582323","NCT06861816","Ventilatory Functions and Physical Intolerance in ESRD Adolescents: Response to Program of Walking With Dogs","Fatigue, Ventilatory Functions, Physical Intolerance, and Life Quality in ESRD Adolescents: Response to Program of Walking With Dogs","Inclusion Criteria:\n\n* adolescents (forty) with ESRD\n* patents on regular hemodiaysis\n\nExclusion Criteria:\n\n* cardiac insult\n* respiratory insult\n* orthopedic problem\n* liver insult","13 Years",{"count":138,"type":21},40,[24],"adolescents with chronic renal failure going on hemodialysis usually complain many problems including compromised ventilation, early fatigue, early physical intolerance, and bad life quality. incentive spirometer is highly recommended to improve these problems. also, walking program, especially walking with dog, can increase the benefits of incentive spirometer",[142,27],"End Stage Renal Disease","2025-03-03",{"date":145,"type":44},"2025-03-06",{"date":147,"type":44},"2025-02-05",{"date":149,"type":21},"2025-06-05",{"name":151,"class":51},"Cairo University",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":171,"locationsCount":52},"100578099","restless-leg-syndrome-is-there-a-response-to-buddhist-walking-meditation-in-hemodialysis-100578099","NCT06806891","Restless Leg Syndrome: Is There a Response to Buddhist Walking Meditation in Hemodialysis","Inclusion Criteria:\n\n* hemodialysis patient (40)\n* complain of restless leg syndrome\n* non obese patients\n\nExclusion Criteria:\n\n* cardiac patients\n* chest diseases\n* mental diseases\n* hepatic diseases\n* lower limb orthopedic hurting","35 Years","65 Years",{"count":138,"type":21},[24],"the restless leg syndrome is a common complaint in person who undergo hemodialysis. Buddhist walking meditation efficacy was not investigated in those population",[27,164],"Restless Legs Syndrome","2025-01-29",{"date":167,"type":44},"2025-02-04",{"date":169,"type":44},"2024-11-06",{"date":145,"type":21},{"name":151,"class":51}]