NCT00418483已完成1 期
A Sequential Phase I/II Dose Escalation and Dose Selection Safety Study of Regional Intra-thrombus Plasmin (Human) Infusion In Acute Lower Extremity Native Artery or Bypass Graft Occlusion
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Thrombolysis
研究概览
简要总结
The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus Plasmin (Human) in acute peripheral arterial occlusion (aPAO). The ability of these Plasmin doses to dissolve the clots will be estimated by arteriography.
详细描述
There is an unmet need for proven thrombolytic agent in acute peripheral arterial occlusion (aPAO). The current assortment of plasminogen activators are slow to dissolve clots in the leg, and may lead to bleeding complications. Plasmin is a direct thrombolytic that may act more quickly when infused directly into the clot and thus assist in restoring blood flow to the leg. There is a large reserve in blood alpha-2 antiplasmin in the blood to rapidly inactivate Plasmin outside of the clot. Plasmin has the potential for an improved bleeding risk profile in aPAO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Women of childbearing potential must use adequate contraception for the duration of the study and must have a negative pregnancy test prior to study entry.
- •Unilateral limb ischemia: SVS acute ischemia Category I or IIa.
- •Onset of symptoms </= 14 days.
- •Thrombosed (non-embolic) infrainguinal graft (synthetic, autologous, or single outflow composite) or infrainguinal native artery. For native arteries, only occlusions of ≥ 10 cm in length are eligible.
- •Diagnosis of occlusive thrombus in the graft or artery by arteriography after Informed Consent is obtained.
- •Ability to traverse the thrombus with a guidewire.
- •Signed informed consent prior to study entry.
排除标准
- •Clinical evidence of significant disease that may interfere with the patient successfully completing the trial.
- •Women who are pregnant or lactating, or first 10 days post-partum.
- •Previous hemorrhagic stroke at any time. Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack (TIA)) within one year.
- •Intracranial or spinal neuro-surgery, or severe intracranial trauma in the last 3 months. Major surgery, organ biopsy, or major trauma within the last 10 days. Lumbar puncture or non-compressible arterial puncture in the last 10 days. Intra-ocular surgery within the last 10 days.
- •Current bleeding diathesis. Active gastrointestinal or organ bleeding. Minor bleeding such as normal menses, cystitis, or minor hemorrhoidal bleeding are not exclusions.
- •Uncontrolled arterial hypertension, defined as a systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg.
- •Known intracranial neoplasm, aneurysm, or arterio-venous malformation.
- •Platelet count < 75 x 10e9/L.
- •Occlusion of a graft within 6 months of placement.
- •Medically unable to tolerate an open vascular procedure.
- •Known prothrombotic condition.
- •Hemoglobin <10.0 g/dL
- •Impaired renal function or renal disease that constitutes a contraindication to contrast angiography, including creatinine > 2.0 mg/dL or subjects on renal dialysis.
- •Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor within the past 5 days, for example, abciximab (ReoPro®), eptifibatide (Integrilin®) or tirofiban (Aggrastat®).
- •Treatment with warfarin (Coumadin®) and with an INR of >1.7 (elevated INR at screening may be corrected prior to study enrollment.)
结局指标
主要结局
Thrombolysis
时间窗: Approximately 5 hours after start of treatment
Thrombolysis at the end of treatment compared to baseline by arteriography
次要结局
- Thrombolysis(Approximately 2 hours after start of treatment)
- Avoidance of both open surgical procedures and additional thrombolysis with a plasminogen activator or mechanical device thrombectomy.(30 days)
- Avoidance of amputation(30 days)
- Physiologic reperfusion defined as improvement in ankle brachial index (ABI)(End of treatment, post intervention procedures, Day 1 to 2, Day 7, and Day 30)
- Avoidance of open surgical procedures(30 days)
- Avoidance of additional catheter-directed thrombolysis with a plasminogen activator or mechanical device thrombectomy(30 days)
- Patency assessed by duplex ultrasound imaging(Day 7 and Day 30)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Safety Study of Hemospan® in Prostatectomy PatientsBlood Loss, SurgicalSurgeryProstate CancerNCT00425334Sangart20
已完成
1 期
Safety Study Involving Oxaliplatin With Docetaxel for Recurrent Ovarian,Primary Peritoneal, and Fallopian Tube CancerPeritoneal CancerFallopian Tube CancerOvarian CancerNCT00692900University of Pittsburgh25
进行中（未招募）
1 期
A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001)Lymphoma, B-CellSmall Lymphocytic LymphomaWaldenstrom MacroglobulinemiaDiffuse Large B Cell LymphomaRichter's TransformationMarginal Zone LymphomaChronic Lymphocytic LeukemiaFollicular LymphomaMantle Cell LymphomaNCT03162536ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)190
招募中
1 期
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.SpasticityNCT04752774Ipsen240
终止
1 期
A Study of PLX51107 in Advanced MalignanciesSolid TumorsAcute Myeloid LeukemiaNon-Hodgkin's LymphomaMyelodysplastic SyndromeNCT02683395Plexxikon50