A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery.

BACKGROUND: This pilot trial focused on feasibility and safety to provide preliminary data to evaluate the hemostatic potential of cold-stored platelets (2° to 6°C) compared with standard room temperature-stored platelets (20° to 24°C) in adult patients undergoing complex cardiothoracic surgery. This study aimed to assess feasibility and to provide information for future pivotal trials. METHODS: A single center two-stage exploratory pilot study was performed on adult patients undergoing elective or semiurgent complex cardiothoracic surgery. In stage I, a two-armed randomized trial, platelets stored up to 7 days in the cold were compared with those stored at room temperature. In the subsequent single-arm stage II, cold storage time was extended to 8 to 14 days. The primary outcome was clinical effect measured by chest drain output. Secondary outcomes were platelet function measured by multiple electrode impedance aggregometry, total blood usage, immediate and long-term (28 days) adverse events, length of stay in intensive care, and mortality. RESULTS: In stage I, the median chest drain output was 720 ml (quartiles 485 to 1,170, n = 25) in patients transfused with room temperature-stored platelets and 645 ml (quartiles 460 to 800, n = 25) in patients transfused with cold-stored platelets. No significant difference was observed. The difference in medians between the room temperature- and cold-stored up to 7 days arm was 75 ml (95% CI, -220, 425). In stage II, the median chest drain output was 690 ml (500 to 1,880, n = 15). The difference in medians between the room temperature arm and the nonconcurrent cold-stored 8 to 14 days arm was 30 ml (95% CI, -1,040, 355). Platelet aggregation in vitro increased after transfusion in both the room temperature- and cold-stored platelet study arms. Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature-stored platelets. CONCLUSIONS: This pilot trial supports the feasibility of platelets stored cold for up to 14 days and provides critical guidance for future pivotal trials in high-risk cardiothoracic bleeding patients.

Cold-stored whole blood in a Norwegian emergency helicopter service: an observational study on storage conditions and product quality.

BACKGROUND: Increasing numbers of emergency medical service agencies and hospitals are developing the capability to administer blood products to patients with hemorrhagic shock. Cold-stored whole blood (WB) is the only single product available to prehospital providers who aim to deliver a balanced resuscitation strategy. However, there are no data on the safety and in vitro characteristics of prehospital stored WB. This study aimed to describe the effects on in vitro quality of storing WB at remote helicopter bases in thermal insulating containers. STUDY DESIGN AND METHODS: We conducted a two-armed single-center study. Twenty units (test) were stored in airtight thermal insulating containers, and 20 units (controls) were stored according to routine procedures in the Haukeland University Hospital Blood Bank. Storage conditions were continuously monitored during emergency medical services missions and throughout remote and blood bank storage. Hematologic and metabolic variables, viscoelastic properties, and platelet (PLT) aggregation were measured on Days 1, 8, 14, and 21. RESULTS: Storage conditions complied with the EU guidelines throughout remote and in-hospital storage for 21 days. There were no significant differences in PLT aggregation, viscoelastic properties, and hematology variables between the two groups. Minor significantly lower pH, glucose, and base excess and higher lactate were observed after storage in airtight containers. CONCLUSION: Forward cold storage of WB is safe and complies with EU standards. No difference is observed in hemostatic properties. Minor differences in metabolic variables may be related to the anaerobic conditions within the thermal box.

Immediate effects of blood donation on physical and cognitive performance-A randomized controlled double-blinded trial.

BACKGROUND: The success of implementing damage control resuscitation principles pre-hospital has been at the expense of several logistic burdens including the requirements for resupply, and the question of donor safety during the development of whole blood programs. Previous studies have reported effects on physical performance after blood donation; however, none have investigated the effects of blood donation on cognitive performance. METHOD: We describe a prospective double-blinded, randomized, controlled study comprised of a battery of tests: three cognitive tests, and VO2max testing on a cycle ergometer. Testing was performed 7 days before blinded donation (baseline day), immediately after donation (Day 0), and 7 days (Day 7) after donation. The inclusion criteria included being active blood donors at the Haukeland University Hospital blood bank, where eligibility requirements were met on the testing days, and providing informed consent. Participants were randomized to either the experimental (n = 26) or control group (n = 31). Control group participants underwent a 'mock donation" in which a phlebotomy needle was placed but blood was not withdrawn. RESULTS: In the experimental group, mean ± SEM VO2max declined 6% from 41.35 ± 1.7 mLO2/(min·kg) at baseline to 39.0 ± 1.6 mLO2/(min·kg) on Day 0 and increased to 40.51 ± 1.5 mLO2/(min·kg) on Day 7. Comparable values in the control group were 42.1 ± 1.8 mLO2/(min·kg) at baseline, 41.6 ± 1.8 mLO2/(min·kg)) on Day 1 (1% decline from baseline), and 41.8 ± 1.8 mLO2/(min·kg) on Day 7.Comparing scores of all three cognitive tests on Day 0 and Day 7 showed no significant differences (p > 0.05). CONCLUSION: Our main findings are that executive cognitive and physical performances were well maintained after whole blood donation in healthy blood donors. The findings inform postdonation guidance on when donors may be required to return to duty. LEVEL OF EVIDENCE: Randomized, controlled, double-blinded prospective trial study, level 1.

Emergency sternal intraosseous access for warm fresh whole blood transfusion in damage control resuscitation.

BACKGROUND: Intraosseous (IO) vascular access is increasingly used as an emergency tool for achieving access to the systemic circulation in critically ill patients. The role of IO transfusion of blood in damage control resuscitation is however questionable due to possible inadequate flow rate and hemolysis. Some experts claim that IO transfusion is contraindicated. In this study, we have challenged this statement by looking at flow rates of autologous fresh whole blood reinfusion and hemolysis using two of the commonly used Food and Drug Administration-approved and Conformité Européenne (CE)-marked sternal needles. Additionally, the success rate of sternal access between the two devices is evaluated. METHODS: Volunteer professional military personnel, were enrolled prospectively in a nonrandomized observational study design. We collected 450 mL of autologous whole blood from each participant. Participants were divided into the following three groups of 10: Tactically Advanced Lifesaving IO Needle (T.A.L.O.N.) IO, FAST1 IO, and intravenous group. The reinfusion was done by gravity only. Blood sampling was performed before blood collection and 30 minutes after reinfusion. Investigation of hemolysis was performed by measurements of haptoglobin and lactate dehydrogenase. Success rate was evaluated by correct aspiration of bone marrow. RESULTS: Median reinfusion rate was 46.2 mL/min in the FAST1 group, 32.4 mL/min in the T.A.L.O.N. group, and 74.1 mL/min in the intravenous group. Blood samples from all participants were within normal ranges. There was no statistically significant difference in haptoglobin and lactate dehydrogenase between the groups. In the FAST1 group, 1 (9%) of 11 procedures failed. In the T.A.L.O.N. group, 4 (29%) of 14 procedures failed. CONCLUSION: Although preferable, achieving peripheral venous access in the bleeding patient is a major problem. Our findings suggest that fresh whole-blood transfusion through the IO route is safe, reliable, and provide sufficient flow for resuscitation. LEVEL OF EVIDENCE: Therapeutic/Care management study, level III.

Making whole blood available in austere medical environments: donor performance and safety.

BACKGROUND: To provide whole blood on the battlefield can be a challenge, but a buddy system protocol is both an elegant and the only currently available means to supply blood to a Special Forces team in far-forward locations. Our aim was to investigate donor-safety associated with such a protocol. METHODS: This study was a randomized, double-blinded, controlled trial that aimed to evaluate the immediate effects of a 450 cc blood donation on physical performance in fatigued and dehydrated Special Forces soldiers. The primary outcome variables were absolute and relative maximal oxygen uptake (VO2max ), exercise tolerance time (ETT) and heart rate (HR). RESULTS: Relative VO2max decreased by 7.1% in the donation group between pre and posttest, compared to no change in the control group. Absolute VO2max decreased by 11.2 and 3.6% between pre and posttest in the donation and control groups, respectively. Mean ETT in the donation group was on average 92 seconds shorter compared to baseline, which represents a decrease of 9.5%. CONCLUSION: Donating blood after a week of strenuous physical activity is feasible for Special Forces personnel. While the donation results in some diminishment of VO2max , a 3.6%-11.2% decrease in relative VO2max , and in elevation of submaximal HR levels highly trained personnel continue to perform well both at both sub-maximal and maximal effort levels.

"Blood failure" time to view blood as an organ: how oxygen debt contributes to blood failure and its implications for remote damage control resuscitation.

Hemorrhagic shock is both a local and systemic disorder. In the context of systemic effects, blood loss may lead to levels of reduced oxygen delivery (DO2 ) sufficient to cause tissue ischemia. Similar to other physiologic debts such as sleep, it is not possible to incur a significant oxygen debt and suffer no consequences for lack of timely repayment. While the linkage between oxygen debt and traditional organ failure (renal, hepatic, lung, and circulation) has been long recognized, we should consider failure in two additional linked and very dynamic organ systems, the endothelium and blood. These systems are very sensitive to oxygen debt and at risk for failing, having further implications on all other organ systems. The degree of damage to the endothelium is largely modulated by the degree of oxygen debt. Thus hypoperfusion is believed to begin a cascade of events leading to acute traumatic coagulopathy (ATC). This combination of oxygen debt driven endothelial damage and ATC might be considered collectively as "blood failure" due to the highly connected networks between these drivers. This article presents the implications of oxygen debt for remote damage control resuscitation strategies, such as permissive hypotension and hemostatic resuscitation. We review the impact of whole blood resuscitation and red blood cell efficacy in mitigation of oxygen debt. At last, this article recognizes the need for simple and durable, lightweight equipment that can detect the adequacy of tissue DO2 and thus patient needs for resuscitative care. Point-of-care lactate measuring may be a predictive tool for identifying high-risk trauma patients and occult shock because it provides information beyond that of vital signs and mechanism of injury as it may help predict the level of oxygen debt accumulation and need for resuscitation. Serial measurements may also be valuable as a tool in guiding resuscitative efforts.

Blood far forward: Time to get moving!

In planning for future contingencies, current problems often crowd out historical perspective and planners often turn to technological solutions to bridge gaps between desired outcomes and the reality of recent experience. The US Military, North Atlantic Treaty Organization, and other allies are collectively taking stock of 10-plus years of medical discovery and rediscovery of combat casualty care after the wars in Iraq and Afghanistan. There has been undeniable progress in the treatment of combat wounded during the course of the conflicts in Southwest Asia, but continued efforts are required to improve hemorrhage control and provide effective prehospital resuscitation that treats both coagulopathy and shock. This article presents an appraisal of the recent evolution in medical practice in historical context and suggests how further gains in far forward resuscitation might be achieved using existing technology and methods based on whole-blood transfusion while research on new approaches continues.

The lost art of whole blood transfusion in austere environments.

The optimal resuscitation fluid for uncontrolled bleeding and hemorrhagic shock in both pre- and in-hospital settings has been an ongoing controversy for decades. Hemorrhage continues to be a major cause of death in both the civilian and military trauma population, and survival depends on adequacy of hemorrhage control and resuscitation between onset of bleeding and arrival at a medical treatment facility. The terms far-forward and austere are defined, respectively, as the environment where professional health care providers normally do not operate and a setting in which basic equipment and capabilities necessary for resuscitation are often not available. The relative austerity of a treatment setting may be a function of timing rather than just location, as life-saving interventions must be performed quickly before hemorrhagic shock becomes irreversible. Fresh whole blood transfusions in the field may be a feasible life-saving procedure when facing significant hemorrhage.