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Lancet (London, England) Aug 2013The balance of risk and benefit from early neurosurgical intervention for conscious patients with superficial lobar intracerebral haemorrhage of 10-100 mL and no... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
The balance of risk and benefit from early neurosurgical intervention for conscious patients with superficial lobar intracerebral haemorrhage of 10-100 mL and no intraventricular haemorrhage admitted within 48 h of ictus is unclear. We therefore tested the hypothesis that early surgery compared with initial conservative treatment could improve outcome in these patients.
METHODS
In this international, parallel-group trial undertaken in 78 centres in 27 countries, we compared early surgical haematoma evacuation within 12 h of randomisation plus medical treatment with initial medical treatment alone (later evacuation was allowed if judged necessary). An automatic telephone and internet-based randomisation service was used to assign patients to surgery and initial conservative treatment in a 1:1 ratio. The trial was not masked. The primary outcome was a prognosis-based dichotomised (favourable or unfavourable) outcome of the 8 point Extended Glasgow Outcome Scale (GOSE) obtained by questionnaires posted to patients at 6 months. Analysis was by intention to treat. This trial is registered, number ISRCTN22153967.
FINDINGS
307 of 601 patients were randomly assigned to early surgery and 294 to initial conservative treatment; 298 and 291 were followed up at 6 months, respectively; and 297 and 286 were included in the analysis, respectively. 174 (59%) of 297 patients in the early surgery group had an unfavourable outcome versus 178 (62%) of 286 patients in the initial conservative treatment group (absolute difference 3·7% [95% CI -4·3 to 11·6], odds ratio 0·86 [0·62 to 1·20]; p=0·367).
INTERPRETATION
The STICH II results confirm that early surgery does not increase the rate of death or disability at 6 months and might have a small but clinically relevant survival advantage for patients with spontaneous superficial intracerebral haemorrhage without intraventricular haemorrhage.
FUNDING
UK Medical Research Council.
Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Cerebral Hemorrhage; Craniotomy; Disabled Persons; Female; Glasgow Coma Scale; Hematoma; Humans; Male; Middle Aged; Time-to-Treatment; Treatment Outcome; Young Adult
PubMed: 23726393
DOI: 10.1016/S0140-6736(13)60986-1 -
Lancet (London, England)Spontaneous supratentorial intracerebral haemorrhage accounts for 20% of all stroke-related sudden neurological deficits, has the highest morbidity and mortality of all... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial.
BACKGROUND
Spontaneous supratentorial intracerebral haemorrhage accounts for 20% of all stroke-related sudden neurological deficits, has the highest morbidity and mortality of all stroke, and the role of surgery remains controversial. We undertook a prospective randomised trial to compare early surgery with initial conservative treatment for patients with intracerebral haemorrhage.
METHODS
A parallel-group trial design was used. Early surgery combined haematoma evacuation (within 24 h of randomisation) with medical treatment. Initial conservative treatment used medical treatment, although later evacuation was allowed if necessary. We used the eight-point Glasgow outcome scale obtained by postal questionnaires sent directly to patients at 6 months follow-up as the primary outcome measure. We divided the patients into good and poor prognosis groups on the basis of their clinical status at randomisation. For the good prognosis group, a favourable outcome was defined as good recovery or moderate disability on the Glasgow outcome scale. For the poor prognosis group, a favourable outcome also included the upper level of severe disability. Analysis was by intention to treat.
FINDINGS
1033 patients from 83 centres in 27 countries were randomised to early surgery (503) or initial conservative treatment (530). At 6 months, 51 patients were lost to follow-up, and 17 were alive with unknown status. Of 468 patients randomised to early surgery, 122 (26%) had a favourable outcome compared with 118 (24%) of 496 randomised to initial conservative treatment (odds ratio 0.89 [95% CI 0.66-1.19], p=0.414); absolute benefit 2.3% (-3.2 to 7.7), relative benefit 10% (-13 to 33).
INTERPRETATION
Patients with spontaneous supratentorial intracerebral haemorrhage in neurosurgical units show no overall benefit from early surgery when compared with initial conservative treatment.
Topics: Aged; Cerebral Hemorrhage; Female; Glasgow Coma Scale; Hematoma; Humans; Male; Middle Aged; Prognosis; Treatment Outcome
PubMed: 15680453
DOI: 10.1016/S0140-6736(05)17826-X -
Stroke Oct 2022Spontaneous intracerebral hemorrhage (sICH) is the deadliest stroke subtype with no effective therapies. Limiting hematoma expansion is a promising therapeutic approach....
BACKGROUND
Spontaneous intracerebral hemorrhage (sICH) is the deadliest stroke subtype with no effective therapies. Limiting hematoma expansion is a promising therapeutic approach. Red blood cell-derived microparticles (RMPs) are novel hemostatic agents. Therefore, we studied the potential of RMPs in limiting hematoma growth and improving outcomes post-sICH.
METHODS
sICH was induced in rats by intrastriatal injection of collagenase. RMPs were prepared from human RBCs by high-pressure extrusion. Behavioral and hematoma/lesion volume assessment were done post-sICH. The optimal dose, dosing regimen, and therapeutic time window of RMP therapy required to limit hematoma growth post-sICH were determined. We also evaluated the effect of RMPs on long-term behavioral and histopathologic outcomes post-sICH.
RESULTS
RMP treatment limited hematoma growth following sICH. Hematoma volume (mm) for vehicle- and RMP- (2.66×10 particles/kg) treated group was 143±8 and 86±4, respectively. The optimal RMP dosing regimen that limits hematoma expansion was identified. RMPs limit hematoma volume when administered up to 4.5-hour post-sICH. Hematoma volume in the 4.5-hour post-sICH RMP treatment group was lower by 24% when compared with the control group. RMP treatment also improved long-term histopathologic and behavioral outcomes post-sICH.
CONCLUSIONS
Our results demonstrate that RMP therapy limits hematoma growth and improves outcomes post-sICH in a rodent model. Therefore, RMPs have the potential to limit hematoma growth in sICH patients.
Topics: Animals; Cell-Derived Microparticles; Cerebral Hemorrhage; Erythrocytes; Hematoma; Hemostatics; Humans; Rats
PubMed: 36069183
DOI: 10.1161/STROKEAHA.122.039641 -
Neurologic Clinics May 2021Intracerebral hemorrhage is a stroke subtype with high mortality and poor functional outcome in survivors. Its main causes are hypertension, cerebral amyloid angiopathy,... (Review)
Review
Intracerebral hemorrhage is a stroke subtype with high mortality and poor functional outcome in survivors. Its main causes are hypertension, cerebral amyloid angiopathy, and anticoagulant treatment. Hematomas have a high frequency of expansion in the first hours after symptom onset, a process associated with neurologic deterioration and poor outcome. Control of severe hypertension, reversal of anticoagulant effect, and management of increased intracranial pressure are the mainstays of management of intracerebral hemorrhage in the acute phase. Surgical evacuation of the hematoma by conventional craniotomy does not improve outcomes, but minimally invasive techniques may be a valuable approach that deserves further evaluation.
Topics: Cerebral Hemorrhage; Emergency Medical Services; Hematoma; Humans; Male; Treatment Outcome
PubMed: 33896526
DOI: 10.1016/j.ncl.2021.02.002 -
EBioMedicine Feb 2022Intracerebral haemorrhage (ICH) is the second most common type of stroke and a major cause of mortality and disability worldwide. Despite advances in surgical... (Review)
Review
Intracerebral haemorrhage (ICH) is the second most common type of stroke and a major cause of mortality and disability worldwide. Despite advances in surgical interventions and acute ICH management, there is currently no effective therapy to improve functional outcomes in patients. Recently, there has been tremendous progress uncovering new pathophysiological mechanisms underlying ICH that may pave the way for the development of therapeutic interventions. Here, we highlight emerging targets, but also existing gaps in preclinical animal modelling that prevent their exploitation. We particularly focus on (1) ICH aetiology, (2) the haematoma, (3) inflammation, and (4) post-ICH pathology. It is important to recognize that beyond neurons and the brain, other cell types and organs are crucially involved in ICH pathophysiology and successful interventions likely will need to address the entire organism. This review will spur the development of successful therapeutic interventions for ICH and advanced animal models that better reflect its aetiology and pathophysiology.
Topics: Animals; Brain; Cerebral Hemorrhage; Hematoma; Humans; Inflammation; Stroke
PubMed: 35158309
DOI: 10.1016/j.ebiom.2022.103880 -
Health Technology Assessment... Sep 2015While it is accepted practice to remove extradural (EDH) and subdural haematomas (SDH) following traumatic brain injury, the role of surgery in parenchymal traumatic... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
While it is accepted practice to remove extradural (EDH) and subdural haematomas (SDH) following traumatic brain injury, the role of surgery in parenchymal traumatic intracerebral haemorrhage (TICH) is controversial. There is no evidence to support Early Surgery in this condition.
OBJECTIVES
There have been a number of trials investigating surgery for spontaneous intracerebral haemorrhage but none for TICH. This study aimed to establish whether or not a policy of Early Surgery for TICH improves outcome compared with a policy of Initial Conservative Treatment.
DESIGN
This was an international multicentre pragmatic parallel group trial. Patients were randomised via an independent telephone/web-based randomisation service.
SETTING
Neurosurgical units in 59 hospitals in 20 countries registered to take part in the study.
PARTICIPANTS
The study planned to recruit 840 adult patients. Patients had to be within 48 hours of head injury with no more than two intracerebral haematomas greater than 10 ml. They did not have a SDH or EDH that required evacuation or any severe comorbidity that would mean they could not achieve a favourable outcome if they made a complete recovery from their head injury.
INTERVENTIONS
Patients were randomised to Early Surgery within 12 hours or to Initial Conservative Treatment with delayed evacuation if it became clinically appropriate.
MAIN OUTCOME MEASURES
The Extended Glasgow Outcome Scale (GOSE) was measured at 6 months via a postal questionnaire. The primary outcome was the traditional dichotomised split into favourable outcome (good recovery or moderate disability) and unfavourable outcome (severe disability, vegetative, dead). Secondary outcomes included mortality and an ordinal assessment of Glasgow Outcome Scale and Rankin Scale.
RESULTS
Patient recruitment began in December 2009 but was halted by the funding body because of low UK recruitment in September 2012. In total, 170 patients were randomised from 31 centres in 13 countries: 83 to Early Surgery and 87 to Initial Conservative Treatment. Six-month outcomes were obtained for 99% of 168 eligible patients (82 Early Surgery and 85 Initial Conservative Treatment patients). Patients in the Early Surgery group were 10.5% more likely to have a favourable outcome (absolute benefit), but this difference did not quite reach statistical significance because of the reduced sample size. Fifty-two (63%) had a favourable outcome with Early Surgery, compared with 45 (53%) with Initial Conservative Treatment [odds ratio 0.65; 95% confidence interval (CI) 0.35 to 1.21; p = 0.17]. Mortality was significantly higher in the Initial Conservative Treatment group (33% vs. 15%; absolute difference 18.3%; 95% CI 5.7% to 30.9%; p = 0.006). The Rankin Scale and GOSE were significantly improved with Early Surgery using a trend analysis (p = 0.047 and p = 0.043 respectively).
CONCLUSIONS
This is the first ever trial of surgery for TICH and indicates that Early Surgery may be a valuable tool in the treatment of TICH, especially if the Glasgow Coma Score is between 9 and 12, as was also found in Surgical Trial In spontaneous intraCerebral Haemorrhage (STICH) and Surgical Trial In spontaneous lobar intraCerebral Haemorrhage (STICH II). Further research is clearly warranted.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN 19321911.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 70. See the NIHR Journals Library website for further project information.
Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Cerebral Hemorrhage, Traumatic; Female; Hematoma; Humans; Male; Middle Aged; Patient Selection; Sample Size; Time-to-Treatment; Treatment Outcome; Young Adult
PubMed: 26346805
DOI: 10.3310/hta19700 -
Tidsskrift For Den Norske Laegeforening... Jan 2017Auricular haematomas typically occur as a result of the auricle being pulled or subjected to blunt trauma in association with contact sports, accidents or violence. An... (Review)
Review
Auricular haematomas typically occur as a result of the auricle being pulled or subjected to blunt trauma in association with contact sports, accidents or violence. An auricular haematoma requires prompt surgical intervention to avoid cauliflower ear, also known as «wrestler’s ear». A cauliflower ear is a permanent deformity made up of connective tissue and cartilage.
Topics: Drainage; Ear Deformities, Acquired; Football; Hematoma; Humans; Martial Arts; Nerve Block
PubMed: 28127072
DOI: 10.4045/tidsskr.15.1279 -
Anaesthesia Jan 2022Haematoma after thyroid surgery can lead to airway obstruction and death. We therefore developed guidelines to improve the safety of peri-operative care of patients...
Management of haematoma after thyroid surgery: systematic review and multidisciplinary consensus guidelines from the Difficult Airway Society, the British Association of Endocrine and Thyroid Surgeons and the British Association of Otorhinolaryngology, Head and Neck Surgery.
Haematoma after thyroid surgery can lead to airway obstruction and death. We therefore developed guidelines to improve the safety of peri-operative care of patients undergoing thyroid surgery. We conducted a systematic review to inform recommendations, with expert consensus used in the absence of high-quality evidence, and a Delphi study was used to ratify recommendations. We highlight the importance of multidisciplinary team management and make recommendations in key areas including: monitoring; recognition; post-thyroid surgery emergency box; management of suspected haematoma following thyroid surgery; cognitive aids; post-haematoma evacuation care; day-case thyroid surgery; training; consent and pre-operative communication; postoperative communication; and institutional policies. The guidelines support a multidisciplinary approach to the management of suspected haematoma following thyroid surgery through oxygenation and evaluation; haematoma evacuation; and tracheal intubation. They have been produced with materials to support implementation. While these guidelines are specific to thyroid surgery, the principles may apply to other forms of neck surgery. These guidelines and recommendations provided are the first in this area and it is hoped they will support multidisciplinary team working, improving care and outcomes for patients having thyroid surgery.
Topics: Airway Obstruction; Cognition; Elective Surgical Procedures; Hematoma; Humans; Hyperbaric Oxygenation; Intubation, Intratracheal; Thyroid Gland
PubMed: 34545943
DOI: 10.1111/anae.15585 -
Transfusion Medicine Reviews Oct 2016Massive transfusions occur frequently in pediatric trauma patients, among some children undergoing surgery, or in children with critical illness. Over the last years,... (Review)
Review
Massive transfusions occur frequently in pediatric trauma patients, among some children undergoing surgery, or in children with critical illness. Over the last years, many authors have studied different aspects of massive transfusions, starting with an operative definition. Some information is available on transfusion strategies and adjunctive treatments. Areas that require additional investigation include: studies to assess which children benefit from transfusion protocols based on fixed ratios of blood components vs transfusion strategies based on biophysical parameters and laboratory tests; whether goal-directed therapies that are personalized to the recipient will improve outcomes; or which laboratory tests best define the risk of bleeding and what clinical indicators should prompt the start and stop of massive transfusion protocols. In addition, critical issues that require further study include transfusion support with whole blood vs reconstituted whole blood prepared from packed red blood cells, plasma, and platelets; and the generation of high quality evidence that would lead to treatments which decrease adverse consequences of transfusion and improve outcomes.
Topics: Blood Coagulation; Blood Component Transfusion; Blood Transfusion; Child; Clinical Trials as Topic; Erythrocyte Transfusion; Hematology; Hemorrhage; Humans; Plasma; Platelet Transfusion; Prospective Studies; Risk; Transfusion Reaction; Treatment Outcome
PubMed: 27287298
DOI: 10.1016/j.tmrv.2016.05.010 -
Blood Coagulation & Fibrinolysis : An... Dec 2014Between 10 and 23% of bleeding episodes in the musculoskeletal system of haemophilia patients occur in the muscles. Until now, the most widely accepted treatment for... (Review)
Review
Between 10 and 23% of bleeding episodes in the musculoskeletal system of haemophilia patients occur in the muscles. Until now, the most widely accepted treatment for muscle haematomas in patients with haemophilia has been a combination of rehabilitation and intravenous infusion of replacement clotting factor, until the haematoma completely disappears. The only way to prevent muscle bleeds in haemophilia is primary haematological prophylaxis (from cradle to college). Home treatment is currently the standard of care for patients with severe haemophilia. When a muscle bleed is suspected, confirmation must be achieved by means of imaging tests (ultrasound, MRI, CT). Then, immediate (early) enhanced on-demand haematological treatment must be started until the full disappearance of the haematoma. If untreated, muscle bleeds can cause complications such as nerve injury, compartment syndrome, myositis ossificans, pseudotumour, and even infection (abscess). Currently, the literature for muscle hematomas in the nonhaemophiliac population suggests that ultrasound-guided percutaneous drainage, or surgical drainage performed as open surgery if percutaneous drainage fails, could be beneficial in terms of achieving better and faster symptom relief. Ultrasound-guided haematoma evacuation is a well tolerated procedure. However, the proportion of unsuccessful evacuations and hematoma recurrence is substantial (13%). Such a rate of unsuccessful evacuation is because of excessive density and/or viscosity of the content. Ideally, haematoma evacuation must be performed before 3-5 days since the beginning of the muscular bleed. Although we have not found publications about ultrasound-guided decompression of muscle haematomas in haemophilia, the current status of progress in both the haematological and ultrasound fields leads us to think that this technique should be increasingly considered for the treatment of haemophilia patients, especially in the case of large haematomas in the liquid phase.
Topics: Blood Coagulation Factors; Hematoma; Hemophilia A; Humans; Injections, Intravenous; Magnetic Resonance Imaging; Muscle, Skeletal; Skin; Suction; Tomography, X-Ray Computed; Ultrasonography, Interventional
PubMed: 24914744
DOI: 10.1097/MBC.0000000000000159