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Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery Clinical research trials and Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery. Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery clinical trial. Human subjects frequently get the finest healthcare available for their Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery  Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery
Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery
For Condition: Hereditary Antithrombin Deficiency
Status: Recruiting
Sponsor(s): GTC Biotherapeutics ,
Synopsis: Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will test the efficacy of recombinant human antithrombin by infusing rh AT prior to, during and following the period of risk or surgical procedure.
Details:
Eligibility:
Study Type: Interventional, Prevention, Non-Randomized, Open Label, Expanded Access Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Have congenital AT deficiency with a personal or family history of venous thrombotic events. - Have a history of congenital AT deficiency that includes 2 or more plasma AT activity levels of 60% normal. - Are scheduled to have an elective procedure known to be associated with a high risk for occurrence of Deep Venous Thrombosis (DVT). This will include surgical patients or pregnant patients scheduled for cesarean section or delivery induction. In addition, hospitalized pregnant HD patients in active labor will be allowed into the study. - Are at least 18 years of age, not exceeding 70 years of age. - Have signed an informed consent form. - Have a negative serum pregnancy test at screening and negative urine pregnancy test at baseline. This only applies to female surgical patients (not scheduled for cesarean section) of childbearing potential. - Are able to comply with the requirements of the study protocol. Exclusion Criteria: - Patients who have a diagnosis of hereditary APC resistance, Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation (G20210A), or acquired (lupus anticoagulant) thrombophilic disorder. - Patients who are scheduled for a neurosurgical procedure or open-heart surgery. - Patients who have an underlying medical condition, which in the opinion of the investigator, could complicate the assessment of the incidence of DVT. - Patients who have a known allergy to goats or goat products. - Patients who have participated in a study employing an investigational drug within 30 days of the start of their participation in the current trial. - Patients using fondaparinux sodium, or are expected to be treated with fondaparinux sodium during the study period.
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: GTC AT III 01002;
Study Start Date: December 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056550
Other Hereditary Antithrombin Deficiency Studies:
1. Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery
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Study to assess the efficacy of recombinant human antithrombin in patients with hereditary antithrombin deficiency undergoing surgery or delivery
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