PRECIS is a prospective, randomized, assessor-blinded, controlled analytic balloon advised at the West China Hospital, Sichuan University (Fig. 1). The abstraction action will chase the Declaration of Helsinki.[32] The ethical approval was accepted for the agreement adaptation 1.2 by the Biological and Medical Ethics Committee (BMEC) of West China Hospital (No. 2015-17). The balloon has been registered in the Current Controlled Trials (ISRCTN20139421). Whereas the neurologic cachet of STBI patients who will not be accepted to accord accord themselves, the affiliated affiliation or acknowledged abettor will be absolutely abreast of the abstraction purpose, procedure, abeyant risks and benefits. Afore the balloon action begins, a leash accord will be alive by a kin or a surrogate. Patients accept the appropriate to abjure any time during the trial.
Figure 1.
Flowchart of PRECIS outline
Therapeutic DC, which is performed on the abject of actualization of intra-operative academician swelling, after-effects in a bigger aftereffect compared with antibacterial DC for STBI patients with accumulation lesions.
Therapeutic DC after-effects in beneath complications and a bigger affection of activity compared with antibacterial DC
The accident of deliver craniectomy for post-operative adverse hypertension in primary craniotomy patients can be quantified by analytic features.
Inclusion Criteria.
Between 15 and 65 years old;
Glasgow Coma Scale (GCS) ≤ 8;
Presence of high- or mix-density bane ≥ 25 ml (contusion, intraparenchymal and SDH);
Progressive abasement of acoustic cachet afterwards 24 h of abrasion (GCS motor annual decreases by 2 credibility or edgeless pupillary response);
Exclusion Criteria.
Bilateral mydriasis of alarmingly endangered status;
Cerebellum contusion;
Penetrating academician injury;
Serious extracranial comorbidites with Abbreviated Abrasion Scale (AIS) > 3;
Beyond 24 h afterwards injury;
Known brainy or concrete affliction which would abash aftereffect assessment;
Breastfeeding or pregnancy;
Definite surgical contraindications;
To admission bendability amid groups, best procedures are the aforementioned amid the ameliorative DC accumulation and the antibacterial DC group, except the cartilage accessory management. Already the acknowledged abettor signs accord and confirms randomization, the action commences. Afore the operation, the best medical treatments will be administered in accordance with the advocacy of the BTF guidelines.[33] For accepting abounding advance (initial, intra-operative and post-operative) of ICP and CPP variations, ICP adviser will be placed afore the craniotomy and kept at atomic 5 canicule afterwards surgery. Given the patients with accumulation bane generally accessory with ventricles compression and midline shift, intraparenchymal ICP adviser will be preferred. The delving will be appropriately placed and anchored in the aboveboard affiliate of bane ancillary conduct through the advised craniotomy cavity afterwards affecting accustomed procedure.
The unilateral agony craniotomy archetypal will be adopted, as appropriate by Potts et al..[34] The attic accessory should locate 1 cm aloft the bound of the skull window. Craniotomy should ability at atomic 15 × 12 cm with absolutely apparent areas, which continued bottomward to the banausic abject and ambit annular the parietal to the ancillary of the midline aural 2 cm. Afterwards accumulation bane evacuation, the dura should be sutured on alleviation and amplification by the banausic fascia or bogus dura. Then, for the antibacterial DC group, the cartilage accessory will be removed. For the ameliorative DC group, the accommodation of whether or not to alter the cartilage accessory will depend on academician swelling. If the academician tissue protrudes aloft the abject of the banausic skull window, the cartilage accessory will not be replaced.
General affliction ecology is aimed to advance SaO2 > 95 %, beggarly systolic claret accountability > 90 mmHg, temperature < 37 °C and PaCO2 35–40 mmHg. Axial venous catheters will be placed in all patients for aggregate ecology and resuscitation.
As per the BTF guideline, a stepwise admission will be adopted to adapt ICP management. Maintaining ICP < 25 mmHg and CPP > 60 mmHg are the ambition of the analytical affliction treatment. Conventional therapies accommodate arch acclivity (30°), ventilation, sedation, osmotic dehydration, alien ventricular arising and neuromuscular blockade. The abbreviate alive propofol (5–100 μg/kg/min) and fentanyl (25–100 μg/h) are acclimated for sedation. Mannitol (1 g/kg) is accepted diuretic for osmotherapy. Equiosmolar hypertonic acrid (23.4 %, 0.686 ml/kg in bolus) will be advised in patients with adverse intracranial hypertension or backlash abnormality advised by mannitol. The abbreviate half-life of vecuronium (0.2 mg/kg/h) is called for neuromuscular aeroembolism agent. Hyperthermia (32 °C–34 °C) will be added to the STBI patients back ICP is adverse alike acute medical treatment.
During analytical care, again computed tomography (CT) browse will appraise intracranial change if ICP > 20 mmHg. For craniotomy patients, deliver DC will be performed back there are abasement of imaging allegation (midline about-face > 5 mm and/or cisternal compression) and cancerous intracranial hypertension (ICP 25–30 mmHg > 1 h or ICP > 30 mmHg, behindhand time). For DC patients, alike there is no accord on the optimal time of cranioplasty,[35] and analytical assay additionally questioned the analogue of “early” which varies from 1 to 4 months,[36,37] it is rational to acclaim cartilage accessory backup as aboriginal as 2 months afterwards anaplasty already their performances accomplishing the analytic standard.
Scheduled CT browse will be performed at 1, 3, 7, 30 and 180 canicule afterwards surgery. Additional CT browse will backpack out depending on the action of patient.
After randomization, patients will be adjourned at 1 anniversary and 1, 6 and 12 months. Patients who cannot be followed up at seven canicule will be adjourned aloft actuality discharged. For upfront avenue patients, their surrogates should mark the antecedent abstracts whether or not could be acclimated in study. All accommodating advice and imaging allegation will be uploaded to a database application the case abode anatomy (CRF).
The antecedent abstracts accumulating will be adjourned at the emergency allowance by an accessory physician. This accumulating will accommodate baseline status, anatomy and/or extremities AIS, agony severity (GCS, motor annual and pupillary reaction), CT ambit (mass bane type, aggregate of haematoma and midline-shift), time of injury-to-operation, annual of abrasion and antecedent class appearance (arterial claret gas parameters, agglomeration and platelet count).
The 1-week aftereffect will accommodate intra-operative academician abscess event, deliver craniectomy, class features, aboriginal complications and ICP and CPP control. Intra-operative ecology ethics will be recorded at the point of delving fixation, dura incision, dura abutment and attic closure. Post-operative ICP ascendancy will be recorded as circadian ICP accountability (number of hrs/d with ICP > 25 mmHg) and absolute ICP accountability (number of canicule with ICP > 25 mmHg), as able-bodied as the aforementioned adjustment recording circadian and absolute CPP accountability (CPP < 60 mmHg).[38]
At 1, 6 and 12 months follow-up, the absolute addled adjudicator will contiguous appraise action outcomes, affection of life, backward complications and time of cranioplasty application accepted questionnaire. The check includes the Continued Glasgow Aftereffect Annual (GOSE), EQ-5D. If the absolved patients cannot appear appointed follow-up, abnormally at time point of 6 or 12 months, the check will be beatific to the accurate abiding address. Alone if these methods are invalid, the abettor will be advised to accomplishment the check by telephone.
The Primary endpoint is a favorable aftereffect at 12 months afterwards randomization as abstinent by GOSE (5–8). The amount accessory endpoint is the affection of activity adumbrated by EQ-5D. Added accessory endpoints accommodate bloodshed and complications at agnate time point, ICP and CPP ascendancy and accident of deliver DC in craniotomy patients.
The assay will be candy on the assumption of intention. Patients who bead out or breach antecedent administration will be advised as the affliction outcome. Considering the anticipation of craniotomy patients advised by deliver DC, an as-treated assay will additionally be implemented, as recommended in two-arm dispensary trial.[39] Parametric abstracts will be declared by beggarly and accepted deviation. Non-parametric abstracts will be declared by average and quartile. Categorical abstracts will be presented application cardinal and percentage.
The primary aftereffect of the abstraction will be evaluated application the Pearson chi-square assay with unadjusted accident arrangement and 95 % aplomb interval. Adapted assay of primary aftereffect will be adjourned application logistic corruption for pre-specified factors and any added covariates presenting cogent aberration amid the two groups. The pre-specified subgroups include: age, GCS, pupillary response, accumulation bane blazon and hypotension. Accessory aftereffect including appraisal of affection of life, bloodshed at 6 and 12 months and accident of complications will additionally be adjourned application unadjusted assay and adapted regression. To investigate the accident factors of postoperative adverse hypertension (salvage DC), univariate and multivariate assay will be acclimated to analyze abeyant variables of craniotomy patients.
Depending on the after-effects of corruption models, the receiver operating curves will be acclimated to appraise the discrimination. The Hosmer–Lemeshow assay will action the goodness-of-fit of models.[40] A P amount < 0.05 is advised statistically significant. All statistical assay will be computed by SPSS software (version 19.0).
Both AEs and SAEs will be recorded in CRF. AE is authentic as any adventitious or abortive ache that occurs during the study. AEs accommodate DC accompanying complications, such as cortical herniation, drain evolution, infection, hydrocephalus and subdural hygroma. SAEs are authentic as any of the following: death, life-threatening events, assiduous abundant state, claim of assay and abiding hospitalization. Already the accessory physicians apprehend SAE, it should be appear to the balloon administration aggregation (TMT) and BMEC aural 24 h. SAEs will be followed up until the affair is appropriately resolved.
The sample admeasurement adding is on the abject of the about-face of outcomes. The favorable aftereffect of DC in antecedent studies ranged from 30 % to 61 %.[9,15,41–43] Some after-effects may not be applicative because they included patients with circulation abrasion and acclimated DC as a accessory therapy. Back primary DC advised patients for accumulation lesions, the favorable aftereffect of antibacterial DC in 781 patients was 38 %.[44–54] In our centre application ameliorative DC, the favorable aftereffect of ameliorative DC was 54 %.[30] Afterwards including a affirmation allowance of 10 % to annual for patients who bead out, we account that a sample admeasurement of 336 (each arm 168) will be acceptable to ability a acceptation akin of 5 % (two-side) and a ability of 80 %. The sample admeasurement will be re-assessed and adapted during acting analysis.
Computer-based axial randomization will admeasure assay with aspersing afterward covariates: age (<40 or ≥ 40 years), GCS (8-6 or 5-3), pupillary acknowledgment (both acknowledging or one acknowledging or no reactive), accumulation bane blazon (subdural or intracerebral) and hypotension. A accidental aspect will be alien to enhance the alternation of the abuse algorithm.[55] Physicians can use blast or computer to annals and randomize acceptable patients. The patients will be assigned to either the ameliorative DC accumulation or the antibacterial DC accumulation and will accept a altered character cardinal for PRECIS records.
Since the abstraction is conducted at a distinct centermost and interventions apparently aftereffect in altered outcomes and qualities of life, ‘ideal blinding’ is not astute in PRECIS. We use an assessor-blinding adjustment to investigate the abstraction outcome. The absolute assessors (IAs) will not be complex in the randomization or intervention. IAs will not be able to admission the administration advice or the specific assay procedures application CRF.
Data Affirmation Ecology Board. The absolute abstracts affirmation ecology lath (DSMB) is accustomed to ensure accommodating affirmation and abstracts confidentiality. The associates of DSMB accommodate neurosurgeons, neurology physicians, ethicists and biological statisticians. The lath associates should accept no conflicts of interests apropos the trial. DSMB is accepted the accomplished ascendancy to admission the database. DSMB will barrage acting analyses and added to acclaim to the abstraction group. The bankrupt allotment of the acting assay will be arcane to TMT and accompanying staff. The recommendations will alone advance absolute the balloon if one annex is decidedly altered (i.e. >3 SDs) with account to primary endpoints or SAEs
Trial Council Team. The balloon council aggregation is amenable for authoritative the all-embracing action of the balloon and final decisions afterward recommendations from DSMB.
Trial Administration Team. The responsibilities of TMT accommodate balloon conception, action design, accommodating safety, affection assurance, abstracts assay and writing. TMT will periodically acquaint anniversary aggregation to conduct allocation meetings. According to recommendations from the acting analysis, TMT will re-calculate and acclimatize the sample admeasurement if needed.
Trial Controlling Team. As the capital administrators of abstraction implementation, adept neurosurgeons aggregate the balloon controlling aggregation (TET). TET will conduct acceptable accommodating screening, abstraction interpretation, accord signature, AEs and SAEs reporting, and the CRFs filling. TET should additionally accommodate specific measures to advance the amateur arrangement and the accommodation of abstracts acquiescence afterward acting analysis.
Trial Abettor Team. The abettor aggregation is composed of IAs and computer abutment accumulation (CSG). Afterward the assumption of blinding, IAs will complete abstraction aftereffect appraisal and abide to DSMB (owning priority) and TMT. CSG will accomplish the online accidental allocation system, database enactment and maintenance.
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