Researchers within the division also engage in active clinical research designed to more effectively diagnose and treat general hematological, bleeding and clotting disorders as well as thoracic malignancies.
Genomic Expression Analysis of Recurrent Pregnancy Loss (Genomics of RPL)
- Clinical Trials #:
- IRB #
- CURRENTLY ENROLLING PARTICIPANTS
The purpose of this research is to gain a deeper understanding into the mechanisms of recurrent pregnancy loss. The overall hypothesis is that there is an identifiable genetic expression, a "metagene", which characterizes recurrent pregnancy losses from autoimmune diseases, thrombophilic disorders, and idiopathic pregnancy loss. We propose to identify these disparate processes that lead to recurrent pregnancy loss.
We are looking for adult women 18 years if age or older. The study participants must have a history of adverse pregnancy outcomes involving pregnancy morbidity and laboratory testing. They must also have pregnancy loss related to thrombosis or thrombophilia. We will also enroll women without APS, VTE or pregnancy loss as normal controls.
Study participants will have blood collected for gene expression analysis and will be contacted approximately every six months for 2 years to review pregnancy and pregnancy related outcomes as well as the participants general health.
For additional information or to enroll, please contact:
Betty Thames, RN
Phone: 919-681-9564
Pager: 919-970-0331
E-mail: elizabeth.thames@dm.duke.edu
Antiphospholipid Antibody Syndrome (APS)
- Clinical Trials Registry # NCT00482794
- IRB # 00013845
- CURRENTLY ENROLLING PARTICIPANTS
The goal of this research study is to identify genetic or environmental factors that may increase susceptibility to Antiphospholipid Antibody Syndrome (APS). APS may cause heart attacks, strokes, include a low platelet count, miscarriages and other health challenges.
We are looking for families where at least one individual has APS, and one or more family members may have an autoimmune disease such as lupus, diabetes, rheumatoid arthritis, multiple sclerosis or other autoimmune disorders.
To participate in the study, families will be asked to agree to the following:
A detailed family history interview conducted over the telephone or in person.
Permission to review medical records related to the diagnosis of APS and/or autoimmune disorders.
One or two blood samples from participants, depending on eligibility.
For additional information or to enroll your family in this research study, please contact:
Sharon Hall
Phone (919) 681-9565
E-mail: apsgenetics@mc.duke.edu
Bridging Anticoagulation in Patients who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery
- Clinical Trials Registry # NCT00786474
- IRB# Pro00015683
- CURRENTLY ENROLLING PARTICIPANTS
Blood thinners, such as warfarin, prevent blood clots from forming, thereby reducing the risk of a stroke or heart attack. When people undergo surgery or certain procedures, they must stop using warfarin to prevent too much bleeding during and after the surgery or procedure. Some doctors prescribe a different blood thinner, one that works more quickly and wears off more quickly, to bridge the gap between starting and stopping warfarin.
The study objectives for the BRIDGE Trial are to evaluate the efficacy of bridging anticoagulation (therapeutic-dose LMWH) on the rate of ATE in patients with atrial fibrillation who require temporary interruption of warfarin and to analyze also the safety of bridging anticoagulation on the rate of major bleeding in patients who require temporary interruption of warfarin.
For additional information, visit https://bridge.dcri.duke.edu/
Reverse II Validation Study
- Clinical Trials Registry # NCT00967304
- IRB# Pro00023848
- CURRENTLY ENROLLING PARTICIPANTS
The Reverse II study is to verify a new method of identifying subjects diagnosed with their first unprovoked blood clot, who have a low risk of recurrence and who can safely stop oral anticoagulant therapy after five to seven months of drug therapy. The method used is a combination of simple data (age, gender, medical history and a blood test called D-Dimer) that should provide a probability of high versus low risk for developing a new blood clot.
For additional information, please contact:
Betty Thames, RN
Phone: 919-681-9564
Pager: 919-970-0331
E-mail: elizabeth.thames@dm.duke.edu
Red Blood Storage Duration Study (Recess)
- Clinical Trials Registry # NCT00991341
- IRB# Pro00020923
Red blood cell (RBC) transfusion increases oxygen delivery as a means to protect tissues from ischemia and hasten post-operative recovery. However, debate exists over transfusions with blood that has been stored for short term vs. long term time periods.
The Recess study is a randomized prospective human study to determine the benefits of using transfused RBC's of various ages with monitored changes in patient outcomes after cardiac surgery.
Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients [PHACS]
- Clinical Trials #:
- IRB#: Pro00011739
- CURRENTLY ENROLLING PARTICIPANTS
There is proven evidence of the association between thrombosis and cancer. The goal of the PHACS study is to determine if a daily injection of a blood-thinner, dalteparin, for three months can safely and effectively reduce the frequency of blood clots in patients at increased risk. This study is enrolling adults only.
PHACS Study Pager: 919-970-8113
Coordinator Contact: Betty Thames, RN
Phone: 919-681-9564
Pager: 919-970-0331
Email: elizabeth.thames@dm.duke.edu
Hemostasis and Thrombosis Center Patient Registry and Specimen Bank
- Clinical Trials #
- IRB #
- CURRENTLY ENROLLING PARTICIPANTS
The purpose of this project is to create a data registry and a specimen repository of people with hemostasis and thrombosis disorders. The project will provide a basis for future epidemiological studies addressing the following :
- Investigating risk factors including family history and genomics
- Longitudinal evaluation of Clinical Outcomes: incidence, recurrence and complications
- Pediatric Thrombosis and Thrombophilia including the burden, risk factors, treatment and management
- Maternal Fetal Medicine including burden, risk factors, adverse pregnancy outcomes, treatment and management
- Evaluation of Quality of Life and Patient Satisfaction with patient care
All information will be collected by an in person interview and review of the Duke Electronic Medical Record.
For more information or to enroll in the study, please contact:
Sheila Lambert-Adams
Phone: 919-684-4613
Pager: 919-970-0654
Email: shelia.lambertadams@dm.duke.edu
Evaluation of Hypercoagulable Markers and Pain Severity in Sickle Cell Patients Randomized to Prophylactic Low Molecular Weight Heparin (Fragmin LMWH Injection) vs Placebo
- Clinical Trials # NCT01419977
- IRB # 00023305
- CURRENTLY ENROLLING PARTICIPANTS
The purpose of this study is to determine whether a prophylactic dose of LMWH reduces activation of coagulation parameters compared to placebo during acute vaso-occlusive episodes in Sickle Cell patients. The study will also compare the time needed to reduce pain scores inpatients receiving prophylactic LMWH versus placebo.
Study participants must be an inpatient with Sickle Cell disease, at least 18 years of age and have a diagnosis of vaso-occlusive crisis on admission.
Study participants will be randomized to receive blinded therapy of Daltepariin or placebo. There will be three blood draws during the study on admission, day two and day five of the hospital stay. Twice daily pain assessments will be taken during the hospital stay. All study drug and procedures will be provided by the study. Study participants will have a post hospital follow-up visit.
For more information or to enroll in the study, please contact:
Betty Thames
Phone: 919-681-9564
Pager: 919-970-0331
E-mail: elizabeth.thames@dm.duke.edu
Sheila Lambert-Adams
Phone: 919-684-4613
Pager: 919-970-0654
E-mail: shelia.lambertadams@dm.duke.edu