Rapid Deployment Hemostat Research Articles

Comparison of modified rapid deployment hemostat dressing with standard haemostat as part of standardized perihepatic packing for major liver trauma in a level 1 trauma center

Introduction Uncontrolled hemorrhage is a major cause of mortality in surgery and trauma. Damage control surgery (DCS) is essential in the management of these cases. The use of topical hemostatic agents has increased over the last two decades with the evolution of DCS and trauma-induced coagulopathy. The aim of this study was to compare the performance of standard perihepatic packing with the addition of either a MRDH (modified rapid deployment hemostat) or a non-MRDH hemostatic dressing. Methods This was a retrospective, comparative analysis of prospectively collected data held in the registry of a level I trauma center in Bologna, Italy, between 2005 and 2019. 33 patients with grade IV/V liver injuries who underwent a standardized perihepatic packing with hemostatic dressings were enrolled in the study. The study group included 21 patients treated with standard packing plus MRDH. The control group included 12 patients treated with standard packing plus a combination of fibrillar absorbable hemostat and human fibrin sealant. Results The two groups were homogeneous in terms of age and American Association for the Surgery of Trauma (AAST) grade although the MRDH one seemed to have more severe injury: hemodynamic instability was present in 95% of MRDH patients vs. 83% in the control group. Also, Injury Severity Score (ISS) and New Injury Severity Score (NISS) were 41 vs 35.5 and 47 vs 39.1, respectively. The incidence of re-bleeding requiring repacking at the second-look laparotomy was 4.7% in MRDH patients vs. 16.7% in non-MRDH patients ( p = .5, OR = 4). The overall complication rate was of 23% after the introduction of MRDH vs. 81% in the control group. Conclusion Despite the potential effectiveness of MRDH, this study does not seem to confirm a significant superiority of this hemostat over the standard.

Thirty Consecutive Uses of a Hemostatic Bandage at a US Army Combat Support Hospital and Forward Surgical Team in Operation Iraqi Freedom

Topical hemostatic agents have generated intense research interest in recent years, prompted in part by the demands of wartime medicine. Numerous animal studies demonstrate variable degrees of efficacy of a variety of agents; however, little clinical data are available in severely traumatized patients. This report describes 30 consecutive uses of the modified rapid deployment hemostat (MRDH) during combat operations in Operation Iraqi Freedom. In a prospective observational fashion, traumatized patients presenting to a combat support hospital or a forward surgical team with difficult to control hemorrhage (due to anatomy, limited resources, or tactical environment) had the MRDH applied to severely bleeding wounds. Basic demographics, wounding mechanism, wound characteristics, circumstances, and efficacy were recorded. Presence of a clinical coagulopathy was also noted. Thirty hemostatic bandages were applied to 19 patients with a wide variety of wounds. All but one application occurred in the operating room. The demographics were mean age 27 years (range, 9-55 years), 95% male, 68% penetrating or fragmentation, and four casualties had a clinical coagulopathy. Hemostasis was achieved following application of the hemostatic agent in 16 of 19 wounds. Rebleeding occurred upon removal in three cases. In all cases, the patient failed conventional interventions at hemostasis before the hemostat was applied. This is the single largest description of the clinical efficacy of the MRDH and the first description during combat operations. The MRDH bandage was an effective hemostat for temporarily controlling hemorrhage in difficult circumstances. Caution should be exercised when removing the dressing as rebleeding may occur.

The mRDH Bandage Provides Effective Hemostasis in Trauma and Surgical Hemorrhage

Traumatic injury is a major global health problem, accounting for approximately 1 in 10 deaths worldwide. Hemorrhagic shock accounts for 30% to 40% of injury-associated deaths (2/3 of those patients surviving to reach the hospital) and is the leading cause of preventable and early in-hospital mortality. Excessive blood loss is an infrequent but important complication of both elective and emergency surgery, increasing the risk of morbidity and mortality and prolonging the duration of hospital stay. The modified rapid deployment hemostat (mRDH) trauma bandage has been developed and tested during the past several years. The mRDH has a unique mechanism of action involving vasoconstriction, platelet activation, and red blood cell activation and is effective in the absence of clotting factors or platelets. The mRDH bandage has shown hemostatic efficacy in patients with severe visceral injuries and hepatic rupture. The following case studies illustrate the effective use of the mRDH bandage in a variety of settings, as follows: (1) application of the mRDH to control severe hemorrhage from an improvised explosive device-induced lower extremity injury in Iraq and (2) the mRDH terminates bleeding from a penetrating groin wound allowing safe neurosurgical intervention while avoiding a groin exploration.

MRDH Bandage for Surgery and Trauma: Data Summary and Comparative Review

Bleeding often poses significant life-threatening situations to surgeons. After trauma, a one-third of civilian casualties and one-half of combat casualties die as a result of exsanguination. Recent advances have provided promising new hemostatic dressings that are applied directly to severely bleeding wounds in the pre-hospital period. The modified Rapid Deployment Hemostat (mRDH) trauma/surgery bandage, containing fully acetylated, diatom-derived, poly-N-acetyl-glucosamine fibers, has a unique multifactorial hemostatic action that incorporates vasoconstriction, erythrocyte agglutination, and platelet and RBC activation. Animal studies have shown that the mRDH bandage quickly and completely stops both venous and arterial bleeding, even in the presence of a coagulopathy. A prospective study in humans is in accord with these findings. The mRDH trauma/surgery bandage was able to increase survival of patients after high-grade liver trauma with an associated coagulopathy. Additional clinical studies support this result.

Control of Troublesome Bleeding During Repair of Acute Type A Dissection with Use of Modified Rapid Deployment Hemostat (MRDH)

Troublesome bleeding occurred in the posterior portion of the proximal anastomosis in an ascending aorta graft, being performed on a patient with acute type A dissection. The suture line was close to the left coronary ostium, and attempts at suturing and other maneuvers failed to control hemorrhage. Modified rapid deployment hemostat (MRDH) was successful in achieving hemostasis. MRDH is a novel hemostatic agent with invaluable use in troublesome bleeding occurring during heart surgery.

Modified Rapid Deployment Hemostat Terminates Bleeding From Hepatic Rupture in Third Trimester

King, David R. MD; de Moya, Mark M. MD; McKenney, Mark G. MD, FACS; Cohn, Stephen M. MD, FACS Author Information

Making Sense of the Preclinical Literature on Advanced Hemostatic Products

A number of new hemostatic products have been developed recently for use in trauma settings of severe uncontrolled bleeding. Currently, the literature on these products is controversial, with efficacy demonstrated under some circumstances but not others. In this review, we analyze the current literature pertaining to four of the most promising products (dry fibrin sealant dressing, Rapid Deployment Hemostat, HemCon chitosan dressing, and QuikClot) that have been suggested for use in combat casualty care applications. In particular, this analysis takes into account the characteristics of the animal models used for efficacy testing of these products, the desired characteristics of hemostatic dressings, and specific safety considerations. Animal models ranged from those featuring low-pressure/low-flow bleeding to those featuring high-pressure/high-flow bleeding. When data are viewed in the context of the specific characteristics of the differing animal models used, seemingly disparate experimental results related to efficacy and safety become quite complementary and lead to recommendations for the use of different products in different injury scenarios. Mission and training requirements will dictate the use of these products by military and civilian prehospital care providers.

Modified Rapid Deployment Hemostat Bandage Terminates Bleeding in Coagulopathic Patients with Severe Visceral Injuries

We recently reported that a new dressing, the Modified Rapid Deployment Hemostat (MRDH) controlled bleeding in hypothermic coagulopathic swine after traumatic liver avulsion. The purpose of this study was to evaluate the MRDH in coagulopathic trauma patients undergoing abbreviated laparotomy. A prospective, observational clinical trial of the MRDH dressing was performed at our Level One Trauma Center in patients with high-grade visceral injuries with coagulopathy who failed conventional therapy and required packing. Attending surgeons graded the injury and the adequacy of hemostasis following application of the dressing. Patients were followed until discharge or death. Ten patients were enrolled: nine severe hepatic injuries, and one major abdominal vascular injury. All patients were hypothermic, acidotic, and clinically coagulopathic. Intraoperative hemostasis was immediately obtained after MRDH placement in all cases except one. There was one death. The Modified Rapid Deployment Hemostat terminates bleeding from severe visceral injuries in coagulopathic patients undergoing abbreviated laparotomy.

Modified Rapid Deployment Hemostat Bandage Reduces Blood Loss and Mortality in Coagulopathic Pigs with Severe Liver Injury

Modified Rapid Deployment Hemostat Bandage Reduces Blood Loss and Mortality in Coagulopathic Pigs with Severe Liver Injury

The rdh bandage: hemostasis and survival in a lethal aortotomy hemorrhage model

Background The Rapid Deployment Hemostat (RDH) Bandage has been designed in collaboration with the Office of Naval Research for the treatment of bleeding because of extremity trauma. It is intended as both a battlefield and civilian severe trauma wound dressing. It consists of a specific formulation of Marine Polymer Technologies' proprietary hemostatic polymer poly-N-acetyl glucosamine, and has received FDA clearance. This study compares the hemostatic capabilities of the RDH Bandage with the standard U.S Army First Aid Field Bandage (AFAFB), utilizing a controlled lethal aortotomy model of hemorrhage. Materials and methods Aortic punch wounds 4 mm in diameter were made in the abdominal aortas of female Yorkshire White swine, and were allowed to bleed for 5 s before application of test materials. Test hemostats were applied to the wound with manual compression for 10 min. Total loss of blood was determined in each experiment. Bandages were removed at the end of 2 h, for those animals that survived, and the onset of re-bleeding was observed. Animals were monitored for an additional 30 min to assess survival following bandage removal. Hemostatic efficacy was judged by the total loss of blood, and the survival of the animals. Results Eighty percent of the animals treated with the RDH Bandage survived the study through the entire protocol, whereas only 40% of those treated with the Army First Aid Field Bandage survived the removal of manual compression step, and none survived following the removal of bandage after the 2 h observation/monitoring period. The average blood loss for the RDH Bandage treated animals was 234 ml, and the average blood loss for the Army First Aid Field Bandage treated animals was 1071 ml, through the observation/monitoring period. Conclusions The RDH Bandage is significantly superior to the standard issue U.S. Army First Aid Field Bandage in the control of hemorrhage in a lethal swine abdominal aortotomy hemorrhage model, resulting in decreased blood loss and increased survival.