Status:
TERMINATED
Clot Dissolving Treatment for Blood Clots in the Lungs
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if tenecteplase plus enoxaparin is safe and effective in the treatment of patients with severe submassive pulmonary embolism.
Detailed Description
This project is a phase III, six-center, randomized trial of tenecteplase to treat severe submassive (systolic blood pressure \>90 mm Hg) pulmonary embolism (PE). "Severe" requires one of the followin...
Eligibility Criteria
Inclusion
- Pulmonary vascular imaging positive for PE within the previous 24 hours
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \>17 years
- Evidence of severe PE: RV hypokinesis on echocardiography, abnormal troponin I or T (any non-normal including indeterminate values, using local reference thresholds) or BNP measurement \>90 pg/mL or NT proBNP \>900 pg/ml (not more than 6 hours prior to CT angiography and not more than 30 hours before enrollment) or a pulse oximetry reading \<95% within previous two hours (\<93% in Denver).
Exclusion
- Systolic blood pressure \< 90 mm Hg at time of informed consent
- Do not resuscitate or do not intubate order
- Systemic fibrinolytic treatment within previous 7 days
- Inability to follow-up at 3 months
- Documented gastrointestinal bleeding within previous 30 days
- Active hemorrhage in any of the following sites at the time of enrollment: intraperitoneal, retroperitoneal, pulmonary, uterine, bladder, or nose.
- Head trauma causing loss of consciousness within previous 7 days
- Any history of hemorrhagic stroke
- Ischemic stroke within the past year
- Prior history of heparin-induced thrombocytopenia
- History of intraocular hemorrhage
- Intracranial metastasis
- Known inherited bleeding disorder, e.g., hemophilia
- Platelet count \< 50,000/uL
- Prothrombin time with an INR \>1.7
- Chest, abdominal, intracranial or spinal surgery within the previous 14 days
- Subacute bacterial endocarditis
- Pregnancy (positive pregnancy test)
- Prior enrollment in the study
- Current treatment with fondiparinux, dalteparin, a direct thrombin inhibitor or administration of a glycoprotein inhibitor within the previous 48 hours.
- Known pericarditis
- Allergy to heparins,or tenecteplase
- Elapsed time that would preclude drug or placebo administration within 24 hours after diagnosis
- Evidence of non-end stage kidney injury (creatinine clearance \< 30 ml/min without chronic hemodialysis treatment; chronic hemodialysis-treated patients are eligible)
- Preexisting end-stage cardiopulmonary disease (heart failure with left ventricular ejection fraction \<20%, known severe pulmonary hypertension or other lung disease causing permanent dependence upon oxygen)
- Any other condition that the investigator believes would pose a significant hazard to the subject
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00680628
Start Date
May 1 2008
End Date
October 1 2012
Last Update
October 12 2022
Active Locations (7)
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1
University of California, Davis Medical Center
Sacramento, California, United States, 95817
2
University of Colorado Hospital
Aurora, Colorado, United States, 80045
3
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114