[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venous-stasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venous-stasis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,59,95,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":4},"100634355","the-gore-viabahn-fortegra-venous-stent-post-approval-study-100634355",false,"NCT07538609","The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study","Preoperative Inclusion Criteria:\n\n* Presence of a lesion necessitating treatment with the GORE® VIABAHN® FORTEGRA Venous Stent, as previously determined by an investigator\u002Fsub-investigator.\n* Patient is at least 18 years of age.\n* Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.\n* Patient is able to provide informed consent themself.\n\nIntraoperative Inclusion Criteria:\n\n* Patient can accommodate an appropriately sized GORE® VIABAHN® FORTEGRA Venous Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.\n* Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.\n* Patient has adequate landing zones free from significant disease requiring treatment beyond the proximal and distal margins of the lesion.\n* Patient has adequate inflow\u002Foutflow to\u002Ffrom the target lesion(s), per investigator\u002Fsub- investigator discretion.\n* Lesion can be traversed with a guidewire.\n\nIntraoperative Exclusion Criteria:\n\n* Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.","ALL","18 Years",{"count":18,"type":19},150,"ESTIMATED","INTERVENTIONAL",[22],"NA","This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.",[25,26,27,28,29,30,31,32],"Venous Thromboses","Venous Disease","Venous Leg Ulcer","Venous Stasis","Venous Ulcer","Venous Stenosis","Venous Occlusion","Vein Thrombosis",[34,35,36,30,37,38,39,40,41,42,26,43,44,45,46],"Vein Stent","VIAFORT","Venous Thrombosis","Gore","Venous occlusion","VIABAHN FORTEGRA","FORTEGRA","Deep Venous Insufficiency","Deep venous","DVT Treatment","Venous Stent","Venous insufficiency treatment options","Venous disease treatment options","NOT_YET_RECRUITING","2026-08-11",{"date":50,"type":51},"2026-08-12","ACTUAL",{"date":53,"type":19},"2026-10-07",{"date":55,"type":19},"2031-05",{"name":57,"class":58},"W.L.Gore & Associates","INDUSTRY",{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":20,"phases":69,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100641858","early-vs-late-tourniquet-release-and-phlebotomy-induced-hemolysis-in-the-emergency-department-tourni-ed-100641858","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",{"count":68,"type":19},792,[22],"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.",[72,73,74,28],"Hemolysis","Blood Specimen Collection","Phlebotomy",[76,77,78,79,80,81,82,83],"hemolysis","phlebotomy","tourniquet","venous stasis","emergency department","blood collection","hemolysis index","randomized controlled trial","2026-06-13",{"date":86,"type":51},"2026-06-16",{"date":88,"type":19},"2026-06",{"date":90,"type":19},"2027-08",{"name":92,"class":93},"Marmara University Pendik Training and Research Hospital","OTHER",1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":20,"phases":105,"briefSummary":107,"conditions":108,"keywords":114,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100570426","phase-3-tissue-repair-gel-in-venous-leg-ulcers-us-100570426","NCT06707090","Tissue Repair Gel in Venous Leg Ulcers (US)","A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)","TRIVIA","Inclusion Criteria:\n\n* Adults 18 years and older\n* Venous insufficiency has been clinically diagnosed clinically and medically confirmed.\n* Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.\n* The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.\n* Target ulcer age must be ≥ 4 weeks at Screening.\n* Participants must have adequate arterial flow as confirmed by ABI\u002FTBI, TB, SPP, TCPo2, or Duplex Doppler.\n* Body mass index (BMI) ≤ 50 kg\u002Fm2.\n* HbA1C ≤12%.\n\nExclusion Criteria:\n\n* Target ulcer has been treated with prohibited medications or therapies.\n* History of radiation at the target ulcer site.\n* Target ulcer decreases in area by 30% or more during screening period.\n* History of osteomyelitis at the target ulcer within 6 months of screening.\n* Participants considered nutritionally deficient.",{"count":104,"type":19},312,[106],"PHASE3","The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.",[27,29,109,28,110,111,112,113],"Venous Stasis Ulcer","Wound Heal","Wounds","Venous Insufficiency of Leg","Non-healing Wound",[115,116,117,118,119],"Tissue Repair","Glucoprime","TR Therapeutics","Debridement","VLU","RECRUITING","2026-02-09",{"date":123,"type":51},"2026-02-12",{"date":125,"type":51},"2025-01-28",{"date":127,"type":19},"2028-02",{"name":117,"class":58},33,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":100,"acronym":101,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":20,"phases":137,"briefSummary":107,"conditions":138,"keywords":140,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100570427","phase-3-tissue-repair-gel-in-venous-leg-ulcers-in-auus-100570427","NCT06707103","Tissue Repair Gel in Venous Leg Ulcers in AU\u002FUS","Inclusion Criteria:\n\n* Adults 18 years and older\n* Venous insufficiency has been clinically diagnosed clinically and medically confirmed.\n* Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.\n* The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.\n* Target ulcer age must be ≥ 4 weeks at Screening.\n* Participants must have adequate arterial flow as confirmed by ABI\u002FTBI, TB, SPP, TCPo2, or Duplex Doppler.\n* Body mass index (BMI) ≤ 50 kg\u002Fm2.\n* HbA1C ≤12%.\n\nExclusion Criteria:\n\n* Target ulcer has been treated with prohibited medications or therapies.\n* History of radiation at the target ulcer site.\n* Target ulcer decreases in area by 30% or more during screening period.\n* History of osteomyelitis at the target ulcer within 6 months of screening.\n* History of cancer in the preceding 5 years (except as noted in the protocol).\n* Participants considered nutritionally deficient.",{"count":104,"type":19},[106],[27,29,109,28,110,139,112,113],"Wound",[115,116,117,118,119],"2025-03-27",{"date":143,"type":51},"2025-04-02",{"date":145,"type":19},"2025-04",{"date":147,"type":19},"2027-02",{"name":117,"class":58},12]