Preoperative Fibrinogen Plasma Concentration Is Associated With Perioperative Bleeding and Transfusion Requirements in Scoliosis Surgery

Study Design. Prospective observational study.

Objective. To investigate the potential association between fibrinogen, bleeding, and transfusion requirements after scoliosis surgery.

Summary of Background Data. Bleeding complications during and after orthopedic surgery are associated with increased morbidity and mortality. Early identification of patients with increased risk of excessive bleeding offers the possibility to initiate countermeasures. Fibrinogen is a key protein in the coagulation cascade, and thus a potential biomarker for bleeding risk.

Methods. A total of 82 otherwise healthy patients (mean age: 15 ± 3 years, 85% girls) undergoing surgery for adolescent idiopathic scoliosis were included in the study. Patient variables (age, gender, operation time, and thrombosis prophylaxis), preoperative laboratory variables (hemoglobin, platelet count, activated partial thromboplastin time [aPTT], prothrombin time [PT], and fibrinogen), peroperative and postoperative bleeding volume, and transfusions were registered. Correlations between laboratory variables and bleeding volume were calculated with Pearson test. Patient variables and laboratory variables were compared with Student t test between patients with bleeding volume in the upper quartile (“bleeders”) and the remaining patients, and between patients with extensive transfusion (defined as >2 U of packed red cells) and no or limited transfusions (≤2 U).

Results. Mean fibrinogen concentration was 3.0 ± 0.7 g/L (range, 1.3– 4.9). Mean total perioperative bleeding volume was 1552 ± 1019 mL (range, 100–5800 mL). Total bleeding volume correlated significantly with preoperative fibrinogen concentration (r = −0.31, P = 0.005) but neither with platelet count, aPTT, nor PT (P = 0.61, 0.46, and 0.57, respectively). Bleeders had significantly lower preoperative fibrinogen plasma concentration (2.6 ± 0.6 vs. 3.1 ± 0.6 g/L, P = 0.002). Of total, 16% (13/82) of the patients were transfused with >2 U of packed red cells. Patients with extensive transfusions had significantly lower preoperative fibrinogen plasma concentration (2.5 ± 0.7 vs. 3.1 ± 0.6 g/L, P = 0.002), while preoperative platelet count, aPTT, and PT did not differ.

Conclusion. The results indicate that preoperative fibrinogen concentration is a limiting factor for postoperative hemostasis during and after scoliosis surgery. Preoperative measurement of fibrinogen concentration provides more information about bleeding volume and transfusion requirements than standard screening tests.

FDA "increasingly concerned with the number of imported medical devices"...Made in the USA ???

Please see our Poll results HERE
Important new recommendations have been issued by the US Food and Drug Administration (FDA) pertaining to medical device import entry review processes.
The FDA's Center for Devices and Radiological Health (CDRH) has published a Letter to Industry dated 24 March 2011 outlining information importers should provide to ensure expedited entry of their products into the US market. The letter and other detailed information about the FDA import review process is available on the FDA website.
"These recommendations will directly impact your company's ability to import medical devices, electronic product components, parts and finished products into the US," states the letter.
Specifically, the FDA recommends better adherence by importers to correct Affirmation of Compliance (AofC) data in order to avoid significant entry delays. An appendix of medical device AofC codes has been included with the FDA's Letter to Industry.
When a product enters the United States, medical device importers should make sure to include AofC codes for the following information:

• Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)
• Device Listing (LST)
• Device Initial Importer (DII)
• Premarket Notification (PMN) 510(k) number, if relevant
• Investigational Device Exemption (IDE)

The agency emphasizes that although use of AofC codes remains voluntary, firms that do make use of them greatly increase their chances of having their devices cleared for import entry faster.
A separate Letter to Industry focusing on the import entry filing process for medical devices that also qualify as electronic radiation products is forthcoming, according to the CDRH.
Any questions regarding the FDA’s import entry review process should be sent to the CDRH’s Office of Compliance Import/Export Safety Staff at cdrhocimport@fda.hhs.gov.

Blog Archives related to China

BioCer Introduce Latest Plant-based Hemostasis and Coated Hernia Repair Technologies to China

BAYREUTH, Germany, March 21, 2011 /PRNewswire/ -- BioCer Entwicklungs GmbH, a Bayreuth, Germanybased medical device manufacturer, are pleased to announce their attendance at the China Medical Equipment Fair (CMEF) Shenzhen, China 15th-19th April 2011. HaemoCer(TM) an Absorbable Polysaccharide Hemostat (APH) and Ti0(2)Mesh(TM) Hernia repair system will be on exhibit at the BioCer booth.

HaemoCer(TM) APH technology is delivered in a powder format developed to meet the challenges of problematic bleeding in surgery. Utilizing Biocer's Polysacharide Ultra-hydrophilic Resorbable Engineering (PURE) process modifies plant-based polymers to create a highly absorptive, biocompatible agent which enhances and accelerates the natural clotting cascade. The PURE technology format of HaemoCer(TM) APH contains no thrombin, collagen, or other human or animal components, and is resorbed within days.

TiO(2)Mesh(TM) is an implant utilizing a biocompatible coating for surgical Hernia repair. Ti0(2)Mesh(TM) combines multiple requirements, specifically addressing the needs of the laparoscopic surgeon. TiO(2)Mesh(TM) offers a complete solution to the laparoscopic surgeon and coincides with the advance and rapid growth of minimally invasive surgery in China.

Heinz-Josef Schmies, Managing Director of BioCer Entwicklungs Gmbh commented, "The introduction at the CMEF of HaemoCer(TM) APH and its proprietary, integrated PURE technology offers Asian-Pacific medical professionals an opportunity to examine directly the latest advance in polysaccharide hemostats. TiO(2)Mesh(TM) which encompasses a cutting edge coating technology combined with all the requirements of the ideal Hernia repair mesh offers a complete solution to unmet needs. We anticipate surgeons and patients in China and Asia-Pacific will benefit from these advanced technological innovations in Hernia repair and Hemostasis."

BioCer Entwicklungs GmbH is a privately-held medical device company and welcomes CMEF visitors to their booth H26, hall 2. For further information, distribution inquiries, and licensing options, please visithttp://www.biocer-gmbh.de/en/.

ProFibrix Initiates Phase II With Lead Hemostasis Product Fibrocaps(TM) in US and Europe

LEIDEN, The Netherlands and SEATTLE, March 8, 2011 /PRNewswire/ -- ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that it has initiated a prospective, multi-center Phase II study with its lead product Fibrocaps at up to 20 sites, including major U.S. and Dutch academic medical centers.
Jaap Koopman, CEO of ProFibrix said: "The start of this large Phase II study in multiple surgical indications is a major milestone in the rapid development of our lead product Fibrocaps. If, as we expect, this study confirms the positive results of our first Phase II trial, we anticipate initiating a pivotal Phase III trial in early 2012, which puts us on track for a BLA filing early 2013."

About Fibrocaps
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, and is stable at room temperature.

About the Study
The second Phase II clinical trial of Fibrocaps (FC002) in the U.S. and Europe builds on the success of ProFibrix's first Phase II study at a number of European centers, which demonstrated a compelling safety and efficacy profile for Fibrocaps. The current Phase II trial is a prospective, randomized, single-blind, controlled study. The study sites include up to 20 major academic and leading private medical centers in the U.S. and Europe. Apart from measuring overall safety , the primary efficacy endpoint of the study is the mean time to hemostasis (TTH) of Fibrocaps versus control. Approximately 130 patients will be randomized across four different surgical indications: peripheral vascular surgery, spinal surgery, liver resection surgery and soft tissue dissection. Completion of the study is expected in the third quarter of 2011.
To allow ProFibrix to conduct the Fibrocaps Phase II clinical trial in the U.S., the company filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration. Following review by the Agency in December 2010, the IND is now open and ProFibrix has started enrolling patients at the participating centers in the U.S. and EU. For more details on the study, please go to http://www.clinicaltrials.gov.

Nycomed sees 60% of sales in emerging markets by 2015

Nycomed has posted a 1.8% dip in turnover for 2010 to 3.17 billion euros, a reasonable result given the effects of generic competition to its gastrointestinal drug pantoprazole.


The Swiss privately-held drugmaker’s adjusted earnings before interest, taxes, depreciation and amortisation reached 850.5 million euros, down 20.9%. Pantoprazole sales fell 27.8% to 908.0 million euros, due principally to the loss of its patent in key European markets, Australia and Switzerland.
Sales of the drug in the USA, where it is sold as Protonix by partner Pfizer, are also falling as a result of 'at risk' launches by Teva and Sun in 2007; US exclusivity did not expire until last month. A lengthy legal battle is ongoing but recent judgments have sided with Nycomed which could pocket damages of up to $2 billion, some analysts have argued.
Much of Nycomed's future success is dependent on its recently-launched chronic obstructive pulmonary disease treatment Daxas (roflumilast). The drug, which hit the market in Denmark, Germany and the UK in September and is now available in several other European Union countries, brought in 3.8 million euros and earlier this week partner Forest Laboratories bagged US approval for the treatment, which will be sold as Daliresp.
Chief executive Hakan Bjorklund noted that a number of other products performed well, particularly from the bovine blood derivative Actovegin,  the haemostatic agent TachoSil (fibrinogen/thrombin), the nasal spray Instanyl (fentanyl) for breakthrough cancer pain and Alvesco (ciclesonide) for asthma. He is particularly pleased with the Zurich-headquartered group's performance in emerging markets where it showed above industry average growth in 2010.
Mr Bjorklund noted that Russia/CIS is Nycomed's largest market and Brazil has moved into second. Emerging markets accounted for 39% of turnover in 2010 and by 2015, "we expect them to make up around 60% of our sales".
He concluded by saying that 2011 results will be impacted by "continuing strong marketing and sales efforts around launches of Daxas and focus on our operations in the emerging markets". 

BioCer release video of HaemoCer the latest technology in powdered Plant based Hemostats from Germany using the DAPI application.

US ARMY STUDY SHOWS STB LIFESAVING TECHNOLOGY'S®FAST® DRESSING SUPERIOR FOR CONTROLLING ARTERIAL BLEEDING.

Rockville, MD - In a study conducted jointly by the US Army Institute of Surgical Research and STB Lifesaving Technologies®, and just published in The Journal of Trauma, STB®'s FAST® (Fibrin Adhesive STat) Dressing was shown to be superior to the most effective available agents for controlling severe arterial bleeding.  
The study compared currently available agents with the FAST® dressing, in a coagulopathic hemorrhage model simulating a gunshot wound to a major peripheral artery.  The FAST® dressing produced significantly better outcomes (higher survival rate, longer survival time, higher incidence of stable hemostasis and less blood loss).  STB®'s FAST® dressing was the only agent that stopped bleeding and prevented exsanguination in most subjects.
 "The consistently better results obtained using the FAST® Dressing reflect the results of applying the unique FAST® technology to this most challenging bleeding problem. The ability to optimally mix the fibrinogen and thrombin components during manufacture results in a hemostatic product of unprecedented effectiveness, flexibility and ease of handling. This technology is unaffected by the coagulation state of the patient and therefore functions when other types of products cannot. This has significant implications for the treatment of both military and civilian casualties," commented Dr. Martin MacPhee, STB®'s Chief Scientific Officer.
The report emphasizes the urgent need for methods such as this to control hemorrhage in the field and operating rooms to potentially reduce war mortality, as uncontrolled bleeding remains the leading cause of potentially preventable death in combat casualties.  Hemorrhage is also a leading cause of death in civilian trauma patients.
"Study after study has confirmed the faith we have in our product's ability to save lives, and it's why we refer to our technology as 'A Breakthrough for Life.' Test results such as this recent report demonstrate why the Army continues to support for our research, assisting us in accelerating the step-up to cGMP manufacturing, and the necessary work required to file for FDA approval to initiate human clinical trials," said Richard Moscarello, STB®'s CEO.