Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis
Deep Vein ThrombosisDeep vein thrombosis (DVT) is a severe disease, and conventional treatment with low molecular weight heparin (LMWH) and warfarin is associated with some degree of long-term sequelae, i.e. post-thrombotic syndrome (PTS). Catheter-directed thrombolytic (CDT) therapy has been introduced worldwide the last two decades. Reports have suggested a beneficial effect of this costly treatment, but there are no randomized clinical trials documenting its short- and long-term efficacy and safety. This multi-center study will randomize patients with acute iliofemoral vein thrombosis to either conventional treatment or CDT in addition to conventional treatment. Main outcome parameters are patency rates at 6 months and prevalence of PTS at 24 months. The main short-term hypothesis is that CDT of first-time acute DVT will increase patency of the affected segments after 6 months from <50% to >80%. The main long-term hypothesis is that CDT will improve long-term functional outcome, i.e. risk of PTS after 2 years from >25% to <10%.
The Catheter Study: Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight...
Embolism and ThrombosisThe purpose of this study is to obtain an estimate of catheter survival in the setting of upper extremity deep vein thrombosis (UEDVT) in patients treated with dalteparin and warfarin. Anticoagulation with dalteparin and warfarin in patients with UEDVT secondary to central venous catheters in patients with an active malignancy is an effective therapy as quantified by the success of catheter preservation. A prolonged line salvage rate without a recurrence of UEDVT will improve the management of cancer patients who develop upper extremity deep venous thrombosis in the setting of a central venous (CV) catheter.
Angiomax in Patients With HIT/HITTS Type II Undergoing Off-Pump Coronary Artery Bypass Grafting...
ThrombocytopeniaThrombosis2 moreThe purpose of this study is to examine the safety and efficacy of Angiomax as an anticoagulation in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia with thrombosis syndrome (HITTS) undergoing off-pump coronary artery bypass (OPCAB) surgery.
Low-Dose rtPA to Treat Blood Clots in Major Arm or Neck Veins
ThrombosisThis study will test the effectiveness of low-dose recombinant tissue plasminogen activator (rtPA, or alteplase) in dissolving blood clots in major arm or neck veins. rtPA is given to patients with heart attacks to dissolve blood clots in blocked coronary arteries. Blood clots that develop in major arm or neck veins usually develop after a venous access device (VAD) or catheter has been placed in the vein. The clot often causes arm, shoulder or neck swelling and pressure or discomfort. Current treatments include removing the VAD, using blood thinners such as heparin and warfarin, or using rtPA to dissolve the clot. All these options have disadvantages, however, including the risk of abnormal bleeding. This study will evaluate whether lower doses of rtPA can effectively dissolve clots without requiring an extended hospital stay, as is needed with the current higher-dose regimen. Patients 18 years of age and older who are enrolled in or are being evaluated for a Clinical Center study and who have a blocked jugular, axillary, subclavian, or brachiocephalic vein may be eligible for this study. The blockage may or may not be associated with use of a VAD. Participants will have one or two treatments with a low dose of rtPA, followed by a blood thinner taken by mouth or by injection for 5 to 7 weeks. On the first treatment day, the patient has a venogram, in which a catheter is placed in an arm vein and passed up to and through the blood clot that is blocking the blood flow in the vein. This is done under an x-ray machine so the radiologist can see exactly where the tube is going. Then, rtPA is injected into the clot about every 30 seconds for 15 to 30 minutes. The catheter is kept in place to maintain access to the vein for additional treatment the next day, if needed. The patient then begins treatment with heparin, either as an outpatient or an inpatient. A second venogram is done the next day. If the venogram shows that the vein is open, anti-clotting treatment with heparin or warfarin continues. If the venogram shows that the vein is still blocked, the rtPA treatment is repeated while the blood thinner treatment continues. The patient has a third venogram the following day. If the vein has opened, heparin and warfarin treatment continues. If the vein is still blocked, the patient's participation in the study ends. Although the patient is no longer formally in the study, he or she may choose to receive additional treatments with rtPA in higher doses at NIH or to continue using blood thinners under the direction of the primary physician. Blood tests are done during blood thinning therapy to monitor and adjust the dosage. Additional blood samples are taken before and at timed intervals after each rtPA treatment to measure the response to therapy. Patients who benefit from rtPA treatment remain on blood thinners for 5 to 7 weeks and then return to NIH for a follow-up venogram to see if the vein is still open. During warfarin therapy, blood tests are done every few days during the first week or two and every 2 weeks thereafter to ensure the optimal drug dose is being administered. If the repeat venogram at 5 to 7 weeks shows that the vein has closed, the blood thinners (warfarin or heparin) will be stopped and the patient's participation in this study will end. If the vein has remained open, the patient's doctor will decide whether or not to continue anti-clotting therapy.
Anticoagulant Therapy With Bivalirudin in the Performance of Percutaneous Coronary Intervention...
Heparin-Induced ThrombocytopeniaThrombosisPrimary Objective: To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with new or previous heparin-induced thrombocytopenia (HIT) / heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing percutaneous coronary intervention (PCI). This will be measured by the composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin (or at hospital discharge, whichever occurs first). The components of the composite endpoint are: a) intracranial bleeding; b) retroperitoneal bleeding; c) bleeding that results in hemodynamic compromise; d) bleeding that requires transfusion of three or more units of whole blood or packed red cells; and e) a decrease in hemoglobin of greater than or equal to g/dL or in hematocrit of greater than or equal to 9%. Secondary Objectives: Each component of the primary composite endpoint. To evaluate the level of anticoagulation achieved with bivalirudin. The goal is to achieve an activated clotting time (ACT) between 300 and 350 sec during PCI and 4-hour bivalirudin infusion. To evaluate bivalirudin's effects on platelet counts.
Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to...
ThrombocytopeniaThrombosisThe purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.
Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
Deep Vein ThrombosisVenous Thromboembolism1 moreThis prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability of the benefit:risk ratio. Additionally, the study intends to evaluate longer-term (i.e., up to 5 years) outcome data while the filter is indwelling.
Rivaroxaban vs. Warfarin in CVT Treatment
Cerebral Vein ThrombosisCerebral venous thrombosis (CVT) is an uncommon venous-type of stroke tends to affect younger patients with somewhat different risk factors and much better outcome compared to arterial strokes. Anti-coagulation is the standard of treatment for patients with (CVT) initially with heparins followed by other oral blood thinners for several months. In this study, the investigators are comparing warfarin with another well-known blood thinner, rivaroxaban, which has a fixed once-daily dose with no need for monitoring in terms of clinical outcomes and complications.
CONtinuous Implantable DOppler Probe Monitoring in Renal Transplantation
Renal Artery ComplicationsRenal Vein ThrombosisINTRODUCTION Vascular complications in kidney transplantation constitute one-third of the early graft loss (EGL) that can be prevented by timely diagnosed cases. A vascular monitoring device may have a possible role in the early identification of graft hypoperfusion critical to reducing graft loss. AIM To evaluate the feasibility of an Implantable Doppler probe as a vascular monitoring device in kidney transplant patients and by obtaining the vital information, inform the protocol development of a definitive RCT. METHODS AND ANALYSIS A mixed-method research design is selected. The quantitative study will comprise a feasibility RCT (fRCT) that will compare demographical characteristics and surgical outcomes of patients that will undergo kidney transplant surgery with vascular monitoring device (intervention group, n=25) against those with standard care clinical observation (control group, n=25). Descriptive statistics will be used to summarise the results that will assess the vascular monitoring capability of implantable Doppler probe in the early postoperative period of kidney transplant patients. The results will provide estimates for surgical outcomes essential to inform the sample size calculation for the definitive study. Information related to the fluency of research methods, availability of research resources, management support, potential challenges faced during the fRCT will be compiled to generate realistic estimates of important parameters for the definitive study. The results will be following the CONSORT updated guidelines for reporting feasibility studies. Qualitative semi-structured interviews of stakeholders (n=12) recruited by purposive sampling will be conducted to explore their experiences of participating in the study, acquire suggestions regarding application of implantable Doppler probe monitoring, and the post implantation patient care. All interviews will be audio-recorded with verbatim transcription. Data will be analysed following the six-phase guide to doing thematic analysis in the NVivo software. The results will be reported in accordance with the consolidated criteria for reporting qualitative research (COREQ) checklist. IMPACT It is anticipated that this study will also elaborate on a possible role of implantable Doppler probe monitoring to improve kidney transplant patient safety, graft survival, service quality improvement, and financial savings in the NHS.
Value of D-dimer Combined With Other Thrombus Molecular Markers in Risk Assessment of VTE in Hospitalized...
Venous Thromboembolic DiseaseThe occurrence of VTE in hospital is an important cause of unexpected death of inpatients, and has become a serious problem faced by hospital managers and clinical medical staff.Under the target of "Improving the Standard Prevention Rate of Venous Thromboembolism" proposed in the "National Medical Quality and Safety Improvement Goal in 2022", it is urgent to establish a highly sensitive VTE risk assessment and monitoring system.At present, VTE risk assessment scale is used for risk screening and monitoring in combination with D-dimer in clinical practice, but D-dimer has low specificity and poor sensitivity, which makes it impossible to accurately assess the risk of venous thrombosis.Therefore, it is very important to explore highly specific molecular markers of thrombosis for VTE risk assessment.This project will analyze the value of single or combined detection of different thrombus molecular markers in VTE risk assessment, establish the best VTE risk assessment scheme, improve the standardized prevention of VTE, realize the early intervention of VTE, truly achieve early detection, early prevention and early treatment, and effectively reduce the occurrence of VTE.