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Bruley D.F.,Synthesizer Inc. | Jagannath S.B.,Johns Hopkins Hospital | Streiff M.B.,Johns Hopkins Medical Institutions
Advances in Experimental Medicine and Biology | Year: 2011

Thrombophilic disorders that predispose patients to develop blood clots can be life-threatening and result in a large economic burden on healthcare expenditures. Venous Thromboembolism(VTE) (deep vein thrombosis and pulmonary embolism) are the third leading cause of death in the United States. ProteinCdeficiency is a common thrombophilic condition that affects an estimated 1 in 400 Americans. Zymogen Protein C (ZPC) is the precursor to Activated Protein C (APC), a pivotal endogenous anticoagulant in human blood. Patients with protein C deficiency who have roughly half the normal level of proteinC are estimated to be at 10-fold increased risk of VTE. We describe the use of protein C concentrate (Ceprotin®, Baxter, Deerfield, IL) in a patient with protein C deficiency and with a previous pulmonary embolism who developed a life-threatening gastrointestinal bleed after polypectomy. The patient is a 75-year-old male at very high risk for deep vein thrombosis and possible lung emboli. He has heterozygous Protein C deficiency (50%) and heterozygosity for the prothrombin gene G20210A mutation. During a routine colonoscopy, a large 3 cm cecal polyp was identified and resected. Eight days post-procedure while performing abdominal exercise he developed a life-threatening GI bleed originating from the polypectomy site as his warfarin was becoming therapeutic on a Low Molecular Weight Heparin (LMWH) periprocedural bridge. The patient's warfarin was reversed with vitamin K, and LMWH and warfarin were discontinued. To prevent thrombosis, he was started on ZPC until anticoagulation could be safely restarted. During endoscopy, the bleeding site was treated with an injection of 1:10,000 dilution of epinephrine, followed by cauterization and placement of endoclips (4 metal staples). Three days after endoscopic repair LMWH was restarted with warfarin. Sixteen months post-bleed, the patient remains on life-long warfarin without further episodes of bleeding or thrombosis. Zymogen Protein C concentrate (Ceprotin®, Baxter Deerfield, IL) should be strongly considered for peri-procedural management of any patient with protein C deficiency and previous thromboembolism. © 2011 Springer Science+Business Media, LLC.

Thakkar S.C.,Johns Hopkins Bayview Medical Center | Streiff M.B.,Johns Hopkins Hospital | Bruley D.F.,Synthesizer Inc. | Mears S.C.,Johns Hopkins Bayview Medical Center
Clinical Orthopaedics and Related Research | Year: 2010

Background Perioperative management of patients with heterozygous protein C deficiency is challenging because of the competing risks of bleeding and recurrent thrombosis. Case Description We report the case of a 74-year-old man with protein C deficiency and heterozygous pro- thrombin G20210A gene mutation who had a successful left THA with perioperative administration of human zymogen protein C concentrate in addition to anticoagulation with enoxaparin. Literature Review Several studies have reported the use of protein C concentrate in severe sepsis-associated pur- pura fulminans in patients with severe congenital protein C deficiency who have had thrombotic events. We reviewed studies and case reports pertinent to the treatment of patients with protein C deficiency, especially in the perioperative setting. We report the case of a patient undergoing THA in whom we used human zymogen protein C concentrate. Purposes and Clinical Relevance THA, a particularly high-risk procedure, is associated with a 40% to 70% incidence of venographic deep venous thrombosis and a 2% to 3% incidence of symptomatic deep venous thrombosis. These risks are greater in people with thrombophilic defects such as protein C deficiency. The use of human zymogen protein C in our patient with heterozygous protein C deficiency during the perioperative period of a THA was associated with no evidence of excessive bleeding, hematoma, deep venous thrombosis, or pulmonary embolism. © The Association of Bone and Joint Surgeons ® 2009.

Bruley D.F.,Synthesizer Inc.
Advances in Experimental Medicine and Biology | Year: 2014

The founding of ISOTT was based upon the blending of Medical and Engineering sciences. This occurrence is portrayed by the Shamattawa, the joining of the Chippewa and Flambeau rivers. Beginning with Carl Scheele’s discovery of oxygen, the medical sciences advanced the knowledge of its importance to physiological phenomena. Meanwhile, engineering science was evolving as a mathematical discipline used to define systems quantitatively from basic principles. In particular, Adolf Fick’s employment of a gradient led to the formalization of transport phenomena. These two rivers of knowledge were blended to found ISOTT at Clemson/Charleston, South Carolina, USA, in 1973. The establishment of our society with a mission to support the collaborative work of medical scientists, clinicians and all disciplines of engineering was a supporting step in the evolution of bioengineering. Traditional engineers typically worked in areas not requiring knowledge of biology or the life sciences. By encouraging collaboration between medical science and traditional engineering, our society became one of the forerunners in establishing bioengineering as the fifth traditional discipline of engineering. © Springer Science+Business Media, LLC 2014.

Bruley D.F.,Synthesizer Inc.
Advances in Experimental Medicine and Biology | Year: 2013

We have defined the Zymogen Protein C (ZPC) to Activated Protein C (APC) process as the silver bullet of blood anticoagulation. This definition suggests that the anticoagulation activity occurs when and where it is needed, resulting in local anticoagulation without enhanced bleeding. It is important for man to be able to manufacture an inexpensive ZPC product or to find a substitute drug to duplicate one of God's natural anticoagulant/antithrombotic processes, in vivo, in human blood. After intense research and at great expense scientists have not been able to produce a safe anticoagulant. All products that are now being used can cause bleeding even if dosing is carefully monitored. In fact many professionals in the health care and the pharmaceutical industries define an anticoagulant as a drug that does cause bleeding. This results in a large financial burden that has been placed on the health care industry because of necessary emergency treatments for dangerous occurrences. In addition, many patients are dying annually due to internal and external bleeds created or enhanced by presently administered anticoagulants. Since there are no safe drugs available it is necessary to use the existing products when a medical condition calls for an anticoagulant. This paper will discuss the ZPC process and why its mechanistic design is one of nature's unique defenses against unwanted blood clotting. The prevention and lysis of clots allows normal blood flow and therefore results in the required tissue oxygenation for cell function and survival. If clinical research is carried out with great care it could uncover other uses of ZPC that will allow safer medical procedures, in addition to its use with standard PC deficiency cases. An important example might be for some brain surgeries where the use of existing anticoagulants is unsafe because of potential bleeds. Clinical research could reveal an efficacious ZPC level (for instance, 125, 150, or 200% of normal) that would prevent dangerous clotting situations from occurring without unnecessary bleeding. © 2013 Springer Science+Business Media New York.

Bruley D.F.,Synthesizer Inc. | Schulick R.D.,Aurora University | Streiff M.B.,Anticoagulation Management Service
Advances in Experimental Medicine and Biology | Year: 2013

The blood clotting mechanism is a very important and complex physiologic process. Blood flow must be continuous through the blood vessels to provide essential oxygen and nutrients to the cells of the body. Dr. Melvin H. Knisely (Honorary First President of ISOTT, 1973) named and pioneered research in blood sludging and clotting which led to his nomination for the Nobel Prize by Dr. August Krogh in 1948. Abnormal clotting is a pathological state that can inhibit and prevent normal blood flow, leading to reduced oxygen transport to tissue from the microcirculation. It can result in the death of cells and tissues, including entire organs as well as the patient. Blood clotting and sludging are common occurrences during and after invasive surgery; thus, it is imperative to find safe procedures to reduce or prevent these deadly phenomena. All anticoagulants used today, for clot prevention and dissolution, can cause excessive bleeding that can lead to enormous medical expense to provide control, otherwise causing patient death. Protein C is a natural protein and is the pivotal anticoagulant in the blood. Due to the mechanism of converting the zymogen protein C (ZPC) to active protein C (APC), only when and where it is needed, and their respective half-lives in the body, the natural anticoagulant, antithrombotic characteristics of APC can be utilized without causing bleeds. © 2013 Springer Science+Business Media New York.

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