Neurogenic bladder in patients with paraplegia: a two-center study of the real-life experience of the patients' journey.

INTRODUCTION: Several patterns of urological dysfunctions have been described following spinal cord injury (SCI), depending on the level and the completeness of the injury. A better understanding of the natural history of neurogenic bladder in patients with SCI, and the description of their successive therapeutic lines based on their clinical and urodynamic pattern is needed to improve their management. This study aimed to describe the real-life successive therapeutic lines in patients with neurogenic lower urinary tract dysfunction (NLUTD) following SCI. METHODS: We conducted a two-center retrospective review of medical files of patients with SCI followed in two French specialized departments of Physical Medicine and Rehabilitation between January 2000 and January 2018. All patients with SCI with a level of lesion bellow T3 and older than 18 years old were eligible. The primary outcome was the description of the natural journey of neurogenic bladder in this population, from the awakening bladder contraction to the last therapeutic line. Survival curves were calculated with a 95-confidence interval using the Kaplan-Meier method. RESULTS: One hundred and five patients were included in this study. Most of the patients were young men with a complete SCI lesion. The median time of treatment introduction was 1 and 9 years for anticholinergics and intradetrusor injection of BoNT/A, respectively. Median duration of effect of treatments was 4 and 6 years post-introduction of anticholinergics and BoNT/A, respectively. CONCLUSION: This study describes NLUTD journey of patients with SCI demonstrating the mid-term efficacy of the two first therapeutic lines of NDO management. An improvement of non-surgical therapeutics is needed.

The impact of age on patient-reported outcomes after oncoplastic versus conventional breast cancer surgery.

PURPOSE: Some studies have indicated age-specific differences in quality of life (QoL) among breast cancer (BC) patients. The aim of this study was to compare patient-reported outcomes after conventional and oncoplastic breast surgery in two distinct age groups. METHODS: Patients who underwent oncoplastic and conventional breast surgery for stage I-III BC, between 6/2011-3/2019, were identified from a prospectively maintained database. QoL was prospectively evaluated using the Breast-Q questionnaire. Comparisons were made between women < 60 and ≥ 60 years. RESULTS: One hundred thirty-three patients were included. Seventy-three of them were ≥ 60 years old. 15 (20.5%) of them received a round-block technique (RB) / oncoplastic breast-conserving surgeries (OBCS), 10 (13.7%) underwent nipple-sparing mastectomies (NSM) with deep inferior epigastric perforator flap (DIEP) reconstruction, 23 (31.5%) underwent conventional breast-conserving surgeries (CBCS), and 25 (34.2%) received total mastectomy (TM). Sixty patients were younger than 60 years, 15 (25%) thereof received RB/OBCS, 22 (36.7%) NSM/DIEP, 17 (28.3%) CBCS, and 6 (10%) TM. Physical well-being chest and psychosocial well-being scores were significantly higher in older women compared to younger patients (88.05 vs 75.10; p < 0.001 and 90.46 vs 80.71; p = 0.002, respectively). In multivariate linear regression, longer time intervals had a significantly positive effect on the scales Physical Well-being Chest (p = 0.014) and Satisfaction with Breasts (p = 0.004). No significant results were found concerning different types of surgery. CONCLUSION: Our findings indicate that age does have a relevant impact on postoperative QoL. Patient counseling should include age-related considerations, however, age itself cannot be regarded as a contraindication for oncoplastic surgery.

[Superficial circumflex iliac artery perforator free flap in pediatric reconstruction: A case report]. / Lambeau libre SCIP en reconstruction pédiatrique : à propos d'un cas.

The dorsalis pedis reconstruction requires to bring a thin tissue to recover every noble structure of the foot including tendons, nerves and vessels while resisting the stress induced on these structures when walking or wearing shoes. We report the case of a thirteen year-old child who presented a third-degree burn sequelae on the dorsalis pedis with scar retraction and chronic ulceration on the fifth metatarsal despite multiple skin grafts. He couldn't put on his shoes because of the pain and walking was difficult. We performed a SCIP flap (Superficial Circumflex Iliac Artery Perforator) to reconstruct this defect. The flap measuring 12×7cm has been harvested on the right groin and anastomosed with the pedicle of the first intermetatarsal space. At 3 months postoperatively, the child can put on his shoes again and walk without pain. The donor site is discrete in the inguinal crease, hidden in the underwear. The SCIP flap is a thin and pliable flap with a discrete donor site. It is suitable for reconstructions of distal extremities of limbs, both in adults and children.

Rationale and methods for a cross-sectional study of mental health and wellbeing following river flooding in rural Australia, using a community-academic partnership approach.

BACKGROUND: Climate change is associated with greater frequency, duration, intensity and unpredictability of certain weather-related events, including floods. Floods harm mental health. There is limited understanding of the mental health and well-being effects from river flooding, particularly over the longer term and in rural contexts. This paper describes the rationale, aims, objectives, study design and socio-demographic characteristics of the sample for a study measuring associations between flood experience and mental health and wellbeing of residents (particularly those most likely to be negatively impacted and hard to reach) in rural NSW Australia 6 months following a devastating flood in 2017. To our knowledge, the study is the first of its kind within Australia in a rural community and is an important initiative given the likelihood of an increasing frequency of severe flooding in Australia given climate change. METHODS: A conceptual framework (The Flood Impact Framework) drawing on social ecological approaches was developed by the research team. It was based on the literature and feedback from the community. The Framework describes putative relationships between flood exposure and mental health and wellbeing outcomes. Within a community-academic partnership approach, a cross-sectional survey was then undertaken to quantify and further explore these relationships. RESULTS: The cross-sectional survey was conducted online (including on mobile phone) and on paper between September and November 2017 and recruited 2530 respondents. Of those, 2180 provided complete demographic data, among whom 69% were women, 91% were aged 25-74, 4% identified as Aboriginal and/or Torres Strait Islander, 9% were farmers and 33% were business owners. CONCLUSIONS: The study recruited a wide range of respondents and the partnership facilitated the community's engagement with the design and implementation of the study. The study will provide a basis for a follow-up study, that will aim to improve the understanding of mental health and wellbeing effects over the longer term. It will provide an important and original contribution to understanding river flooding and mental health in rural Australia, a topic that will grow in importance in the context of human-induced climate change, and identify critical opportunities to strengthen services, emergency planning and resilience to future flooding.

[Clinical photography by smartphone in plastic surgery and protection of personal data: Development of a secured platform and application on 979 patients]. / Photographie clinique par smartphone en chirurgie plastique et protection des données personnelles : développement d'une plateforme sécurisée et application sur 979 patients.

BACKGROUND: The clinical photography in plastic and reconstructive surgery has known a numerical breakthrough. The storage of online data, massive means of analysis such as facial recognitions algorithms poses a serious issue when it comes to the protection of personal data. We will assess a platform's benefits in connection with the computerized medical record, which will allow keeping the photos filed and centralized in a smart and secure manner. METHOD: We interviewed 300 plastic surgeons about the role of smartphone in their clinical practice. Concomitantly, we developed an innovative platform called Surgeon©, a secure way to index, file and send photographs with a smartphone on our hospital's server. Each photographic sequence was qualified using a specific form. We then collected prospectively, between May 1st 2017 and March 30th 2018, the number of patients photographed, the number of sequences and photographs taken and the average number of sequences per patient. RESULTS: Out of 86 French plastic surgeons surveyed, 81% say that they could not go on with their daily practice today without their smartphone. Photographs taken were stored in their smartphones (50%) or synced with virtual storage (25.6%). A majority (80.2%) would use a dedicated secured smartphone application. Our application allowed us to photograph 979 patients, or 2345 sequences and 8112 photographs, with an average of 2.28 sequences per patient. CONCLUSION: Thanks to its ergonomics and security, this platform can be set up in a hospital ward and beyond.

EFNB2 haploinsufficiency causes a syndromic neurodevelopmental disorder.

Ephrin B2, one of the ligand of the EphB receptors, is involved in a complex signaling pathway regulating the development of the nervous system, neuronal migration, erythropoiesis and vasculogenesis. We report a patient with a de novo variant in EFNB2 and a family in which segregates a 610-kb deletion at chromosome 13q33 encompassing only ARGLU1 and EFNB2 genes. The de novo variant was observed in a patient with anal stenosis, hypoplastic left ventricle and mild developmental delay. The deletion was identified in 2 sibs with congenital heart defect and mild developmental delay. One of the affected sibs further had myoclonic epilepsy and bilateral sensorineural hearing loss. The carrier mother was apparently asymptomatic. Because EFNB2 is located in the subtelomeric region of 13q chromosome, we reviewed the previous reports of terminal 13q deletion. We suggest that haploinsufficiency of the EFNB2 could be at the origin of several clinical features reported in 13qter deletions, including intellectual disability, seizures, congenital heart defects, anorectal malformation and hearing loss.

NR4A2 haploinsufficiency is associated with intellectual disability and autism spectrum disorder.

NR4A2, a member of the nuclear receptor superfamily, is involved in modulation of target gene transcription, regulating several developmental processes such as regulation of cellular homeostasis, neuronal development, inflammation and carcinogenesis. 2q24.1 deletions are extremely rare, and only 1 patient with a de novo deletion encompassing only NR4A2 gene was reported so far. We report 3 additional patients with a de novo deletion encompassing NR4A2: 2 patients have deletions encompassing only NR4A2 gene and 1 patient has a deletion including NR4A2 and the first exon of GPD2. Our patients presented a neurodevelopmental disorder including language impairment, developmental delay, intellectual disability and/or autism spectrum disorder. We suggest that NR4A2 haploinsufficiency is implicated in neurodevelopmental disorder with high penetrance.

INTU-related oral-facial-digital syndrome type VI: A confirmatory report.

Oral-facial-digital (OFD) syndromes are a subgroup of ciliopathies distinguished by the co-occurrence of hamartomas and/or multiple frenula of the oral region and digital anomalies. Several clinical forms of OFD syndromes are distinguished by their associated anomalies and/or inheritance patterns, and at least 20 genetic types of OFD syndromes have been delineated. We describe here a child with preaxial and postaxial polydactyly, lingual hamartoma, a congenital heart defect, delayed development and cerebellar peduncles displaying the molar tooth sign. Whole-exome sequencing and SNP array identified compound heterozygous variants in the INTU gene, which encodes a protein involved in the positioning of the ciliary basal body. INTU is a subunit of the CPLANE multiprotein complex essential for the assembly of IFT-A particles and intraflagellar transport. This report of a second patient with INTU-related OFD syndrome and the further delineation of its neuroimaging and skeletal phenotype now allow INTU-related OFD syndromes to be classified within the OFD syndrome type VI group. Patients display a phenotype similar to that of mice with a hypomorphic mutation of Intu, but with the addition of a heart defect.

Sugammadex hypersensitivity and underlying mechanisms: a randomised study of healthy non-anaesthetised volunteers.

BACKGROUND: We investigated potential for hypersensitivity reactions after repeated sugammadex administration and explored the mechanism of hypersensitivity. METHODS: In this double-blind, placebo-controlled study (NCT00988065), 448 healthy volunteers were randomised to one of three arms to receive three repeat i.v. administrations of either sugammadex 4 mg kg-1, 16 mg kg-1, or placebo. Primary endpoint was percentage of subjects with hypersensitivity (assessed by an independent adjudication committee). Secondary endpoint of anaphylaxis was classified per Sampson and Brighton criteria. Exploratory endpoints included skin testing, serum tryptase, anti-sugammadex antibodies [immunoglobulin (Ig) E/IgG], and other immunologic parameters. RESULTS: Hypersensitivity was adjudicated for 1/148 (0.7%), 7/150 (4.7%), and 0/150 (0.0%) subjects after sugammadex 4 mg kg-1, 16 mg kg-1, and placebo, respectively. After sugammadex 16 mg kg-1, one subject met Sampson criterion 1 and Brighton level 1 (highest certainty) anaphylaxis criteria; two met Brighton level 2 criteria. After database lock it was determined that certain protocol deviations could have introduced bias in the reporting of hypersensitivity signs/symptoms in a subject subset. Objective laboratory investigations indicated that potential underlying hypersensitivity mechanisms were unlikely to have been activated; the results suggest that most of the observed hypersensitivity reactions were unlikely IgE/IgG-mediated. CONCLUSION: Dose-dependent hypersensitivity or anaphylaxis reactions to sugammadex were observed when administered without prior neuromuscular blocking agent. Laboratory investigations do not suggest prevalent allergen-specific IgE/IgG-mediated immunologic hypersensitivity. Because it could not be fully excluded that estimates of hypersensitivity/anaphylaxis incidence were unbiased, an additional study was conducted to characterise the potential for hypersensitivity reactions and is described in a companion report. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov NCT00988065; Protocol number P06042.

Modeling the resiliency of energy-efficient retrofits in low-income multifamily housing.

Residential energy efficiency and ventilation retrofits (eg, building weatherization, local exhaust ventilation, HVAC filtration) can influence indoor air quality (IAQ) and occupant health, but these measures' impact varies by occupant activity. In this study, we used the multizone airflow and IAQ analysis program CONTAM to simulate the impacts of energy retrofits on indoor concentrations of PM2.5 and NO2 in a low-income multifamily housing complex in Boston, Massachusetts (USA). We evaluated the differential impact of residential activities, such as low- and high-emission cooking, cigarette smoking, and window opening, on IAQ across two seasons. We found that a comprehensive package of energy and ventilation retrofits was resilient to a range of occupant activities, while less holistic approaches without ventilation improvements led to increases in indoor PM2.5 or NO2 for some populations. In general, homes with simulated concentration increases included those with heavy cooking and no local exhaust ventilation, and smoking homes without HVAC filtration. Our analytical framework can be used to identify energy-efficient home interventions with indoor retrofit resiliency (ie, those that provide IAQ benefits regardless of occupant activity), as well as less resilient retrofits that can be coupled with behavioral interventions (eg, smoking cessation) to provide cost-effective, widespread benefits.

What is the evidence for platelet transfusion in perioperative settings?

BACKGROUND AND OBJECTIVES: Platelet transfusions are widely administered to restore perioperative haemostasis in haemorrhagic patients; however, the role of platelet transfusion is not well understood and administration is often based on empiric data. This review aims to explore consensus regarding platelet transfusion trigger, dose and how the haemostatic efficacy of platelet transfusion was assessed for the treatment of perioperative bleeding. MATERIALS AND METHODS: A literature search was carried out using MEDLINE (PubMed) on 28 February 2017, to identify publications reporting the effect of platelet transfusion in relation to triggers, dose and assessment of haemostatic efficacy in bleeding patients in a perioperative setting. RESULTS: Eight publications were identified across a variety of settings, covering both prophylactic and therapeutic platelet transfusion in adult patients; the majority of the reports were in cardiac surgery. A high degree of variability was observed in the published studies, with only 50% of articles specifying a trigger for platelet transfusion. The most commonly used trigger was platelet count (25% of publications), with no consensus identified regarding the platelet count values used as triggers. Doses reported per transfusion varied from 1 to 12 units, and outcome measures were mixed, although the majority of publications (63%) assessed the requirement for transfusion with other blood products. CONCLUSION: The lack of consensus in published studies hinders our ability to draw conclusions regarding platelet transfusion and highlights the need for further studies to assess the appropriate dose and triggers for use in perioperative patients.

Adult extracorporeal membrane oxygenation: an international survey of transfusion and anticoagulation techniques.

BACKGROUND AND OBJECTIVES: Extracorporeal membrane oxygenation (ECMO) is a method of life support for either isolated cardiac failure or respiratory failure, with or without cardiac failure. When used for hemodynamic support, the ECMO circuit presents a non-endothelialized, artificial surface to blood inciting an inflammatory response which activates haemostatic pathways. Anticoagulation may complicate a pre-existing coagulopathy and/or inadequate surgical hemostasis of varying severity. There is no standardized method to achieve and monitor anticoagulation or guide transfusion therapy during ECMO. We tested the hypothesis that institutions across the world conduct similar management of anticoagulation and transfusion during adult ECMO support. METHODS: This is a descriptive, self-reporting cross-sectional survey of anticoagulation and transfusion practice for patients age 18 or older on ECMO. This 38 multiple-choice question survey was sent to 166 institutions, internationally, utilizing adult ECMO. About 32·4% (54) of institutions responded. Responses were anonymously collected. Descriptive analyses were calculated. RESULTS: Our findings indicate there appears to be a significant practice variation among institutions regarding anticoagulation and transfusion during adult ECMO support. DISCUSSION: The lack of standard practices among institutions may reflect a paucity of data regarding optimal anticoagulation and transfusion for patients requiring ECMO. Standardized protocols for anticoagulation and transfusion may help increase quality of care for and reduce morbidity, mortality and cost to patients and healthcare centres. Further study is required for standardized, high quality care.

Respiratory impairment in multiple sclerosis: a study of respiratory function in wheelchair-bound patients.

BACKGROUND AND PURPOSE: Respiratory disorders are a major cause of morbidity and mortality in multiple sclerosis (MS). Mainly reported in walking patients, they are poorly explored when walking is severely impaired. To characterize respiratory impairment in patients with advanced MS. METHODS: From 2012 to 2015, patients with MS with an Expanded Disability Status Scale (EDSS) score of ≥7 who were referred for functional and rehabilitation evaluation underwent pulmonary function tests to study lung volumes, cough efficacy and respiratory muscle pressures. RESULTS: Among 73 patients with a median EDSS score of 8 [7.5; 8.5], 72.6% had impaired respiratory function with a mean vital capacity (VC) of 57.9 ± 33.5% of theoretical value. Severe impairment (VC < 50%) was found for 34 (46.6%) patients. Cough was impaired in 45 (61.6%) patients, with a mean cough peak flow of 3.14 ± 1.9 L/s and severe impairment (cough peak flow < 2.67 L/s) in 27 (37.0%) patients. Overall, the results suggested predominant expiratory muscle dysfunction and non-predominant diaphragm impairment. EDSS score was correlated with VC but not with any other clinical data. CONCLUSION: Restrictive respiratory failure is frequent in severely impaired patients with MS, predominantly involves expiratory muscles, does not involve diaphragm weakness and is associated with cough impairments.

Perioperative management of the bleeding patient.

Perioperative bleeding remains a major complication during and after surgery, resulting in increased morbidity and mortality. The principal causes of non-vascular sources of haemostatic perioperative bleeding are a preexisting undetected bleeding disorder, the nature of the operation itself, or acquired coagulation abnormalities secondary to haemorrhage, haemodilution, or haemostatic factor consumption. In the bleeding patient, standard therapeutic approaches include allogeneic blood product administration, concomitant pharmacologic agents, and increasing application of purified and recombinant haemostatic factors. Multiple haemostatic changes occur perioperatively after trauma and complex surgical procedures including cardiac surgery and liver transplantation. Novel strategies for both prophylaxis and therapy of perioperative bleeding include tranexamic acid, desmopressin, fibrinogen and prothrombin complex concentrates. Point-of-care patient testing using thromboelastography, rotational thromboelastometry, and platelet function assays has allowed for more detailed assessment of specific targeted therapy for haemostasis. Strategic multimodal management is needed to improve management, reduce allogeneic blood product administration, and minimize associated risks related to transfusion.

Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): a double-blind phase III study of haemostatic therapy.

BACKGROUND: Single-dose human fibrinogen concentrate (FCH) might have haemostatic benefits in complex cardiovascular surgery. METHODS: Patients undergoing elective aortic surgery requiring cardiopulmonary bypass were randomly assigned to receive FCH or placebo. Study medication was administered to patients with a 5 min bleeding mass of 60-250 g after separation from bypass and surgical haemostasis. A standardized algorithm for allogeneic blood product transfusion was followed if bleeding continued after study medication. RESULTS: 519 patients from 34 centres were randomized, of whom 152 (29%) met inclusion criteria for study medication. Median (IQR) pretreatment 5 min bleeding mass was 107 (76-138) and 91 (71-112) g in the FCH and placebo groups, respectively (P=0.13). More allogeneic blood product units were administered during the first 24 h after FCH, 5.0 (2.0-11.0), when compared with placebo, 3.0 (0.0-7.0), P=0.026. Fewer patients avoided transfusion in the FCH group (15.4%) compared with placebo (28.4%), P=0.047. The FCH immediately increased plasma fibrinogen concentration and fibrin-based clot strength. Adverse event rates were comparable in each group. CONCLUSIONS: Human fibrinogen concentrate was associated with increased allogeneic blood product transfusion, an unexpected finding contrary to previous studies. Human fibrinogen concentrate may not be effective in this setting when administered according to 5-minute bleeding mass. Low bleeding rates and normal-range plasma fibrinogen concentrations before study medication, and variability in adherence to the complex transfusion algorithm, may have contributed to these results. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier no. NCT01475669; EudraCT trial no. 2011-002685-20.

[Vaccination of premature infants, a population at high risk of infection]. / Les enfants prématurés, une population à haut risque d'infection qui doit être protégée par la vaccination.

The incidence of prematurity has steadily increased in Belgium these last years, reaching 7,9 % in 2010. Infections remain for these infants an important cause of morbidity and mortality during their hospitalization in the neonatal intensive care units as well as during their first months of life in the community. Despite the immaturity of their immune system, their ability to develop a protective immune response to most vaccines has been established. Instable very low birth weight prematures are at risk cardio- respiratory incidents after vaccine administration, but these incidents are transient and without consequences if they are monitored during and after vaccination. This paper reviews the current recommendations on the immunization of the premature infants.

Erectile dysfunction is a strong predictor of poor quality of life in men with Type 2 diabetes mellitus.

AIMS: To identify predictors of poor quality of life among men with diabetes from a comprehensive set of sexual, clinical, socio-economic and lifestyle variables. METHODS: This was a cross-sectional observational-study of 253 men with Type 2 diabetes, randomly selected from a clinic in Colombo, Sri Lanka. Erectile dysfunction was assessed using the five-item International Index of Erectile Function and quality of life was assessed using the Sri Lankan version of the 36-item short form health survey questionnaire and the disease-specific Psychological Impact of Erectile Dysfunction scale. The presence of premature ejaculation, reduced libido, socio-demographic and lifestyle data was obtained using an interviewer-administered questionnaire. Significant predictors of quality of life were identified by stepwise multivariate linear regression models for short form-36 subscales, summary scales and two scales of Psychological Impact of Erectile Dysfunction. RESULTS: Significant predictors on the physical summary scale of the 36-item short form were erectile dysfunction (ß = 7.93, 95% CI 3.70-12.17, P < 0.001) and reduced libido (ß = 5.20, 95% CI 0.82-9.59, P < 0.05). Predictors on the mental health summary scale of the 36-item short form were erectile dysfunction (ß = 5.82, 95% CI 2.26-9.37, P < 0.01), BMI > 27.5 kg/m(2) (ß = 9.12, 95% CI 1.38-17.44, P < 0.05), ischaemic heart disease (ß = 6.39, 95% CI 0.74-12.04, P < 0.05) and insulin therapy (ß = 5.28, 95% CI 0.34-10.22, P < 0.05). Significant predictors in the sexual experience scale of the Psychological Impact of Erectile Dysfunction were erectile dysfunction (ß = 6.57, 95% CI 4.63-8.51, P < 0.001), reduced libido (ß =4.33, 95% CI 2.34-6.32, P < 0.001) and postural hypotension (ß = 3.99, 95% CI 0.13-7.85, P < 0.05). Predictors on the emotional life scale of the Psychological Impact of Erectile Dysfunction were erectile dysfunction (ß = 2.96, 95% CI 1.37-4.58, P < 0.001), reduced libido 2.75 (ß = 2.75, 95% CI 1.12-4.40, P < 0.01), younger age (ß = 1.05, 95% CI 0.35-1.75, P < 0.01) and postural hypotension (ß = 3.39, 95% CI 0.35-6.45, P < 0.05). CONCLUSION: Erectile dysfunction was a strong predictor of poor generic and disease-specific quality of life among other sexual and clinical variables in men with diabetes.

Cryoprecipitate therapy.

Cryoprecipitate, originally developed as a therapy for patients with antihaemophilic factor deficiency, or haemophilia A, has been in use for almost 50 yr. However, cryoprecipitate is no longer administered according to its original purpose, and is now most commonly used to replenish fibrinogen levels in patients with acquired coagulopathy, such as in clinical settings with haemorrhage including cardiac surgery, trauma, liver transplantation (LT), or obstetric haemorrhage. Cryoprecipitate is a pooled product that does not undergo pathogen inactivation, and its administration has been associated with a number of adverse events, particularly transmission of blood-borne pathogens and transfusion-related acute lung injury. As a result of these safety concerns, along with emerging availability of alternative fibrinogen preparations, cryoprecipitate has been withdrawn from use in a number of European countries. Compared with the plasma from which it is prepared, cryoprecipitate contains a high concentration of coagulation factor VIII, coagulation factor XIII, and fibrinogen. Cryoprecipitate is usually licensed by regulatory authorities for the treatment of hypofibrinogenaemia, and recommended for supplementation when plasma fibrinogen levels decrease below 1 g litre(-1); however, this threshold is empiric and is not based on solid clinical evidence. Consequently, there is uncertainty over the appropriate dosing and optimal administration of cryoprecipitate, with some guidelines from professional societies to guide clinical practice. Randomized, controlled trials are needed to determine the clinical efficacy of cryoprecipitate, compared with the efficacy of alternative preparations. These trials will allow the development of evidence-based guidelines in order to inform physicians and guide clinical practice.