scholarly journals Drainage, irrigation and fibrinolytic therapy (DRIFT) for posthaemorrhagic ventricular dilatation: 10-year follow-up of a randomised controlled trial

2020 ◽  
Vol 105 (5) ◽  
pp. 466-473 ◽  
Author(s):  
Karen Luyt ◽  
Sally L Jary ◽  
Charlotte L Lea ◽  
Grace J. Young ◽  
David E Odd ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Fibrinolytic Therapy ◽  
Ventricular Dilatation ◽  
Cognitive Disability ◽  
Randomised Controlled ◽  
Standard Treatment Group

BackgroundProgressive ventricular dilatation after intraventricular haemorrhage (IVH) in preterm infants has a very high risk of severe disability and death. Drainage, irrigation and fibrinolytic therapy (DRIFT), in a randomised controlled trial (RCT), reduced severe cognitive impairment at 2 years.ObjectiveTo assess if the cognitive advantage of DRIFT seen at 2 years persisted until school age.ParticipantsThe RCT conducted in four centres recruited 77 preterm infants with IVH and progressive ventricular enlargement over specified measurements. Follow-up was at 10 years of age.InterventionIntraventricular injection of a fibrinolytic followed by continuous lavage, until the drainage was clear, and standard care consisting of control of expansion by lumbar punctures and if expansion persisted via a ventricular access device.Primary outcomeCognitive quotient (CQ), derived from the British Ability Scales and Bayley III Scales, and survival without severe cognitive disability.ResultsOf the 77 children randomised, 12 died, 2 could not be traced, 10 did not respond and 1 declined at 10-year follow-up. 28 in the DRIFT group and 24 in the standard treatment group were assessed by examiners blinded to the intervention. The mean CQ score was 69.3 (SD=30.1) in the DRIFT group and 53.7 (SD=35.7) in the standard treatment group (unadjusted p=0.1; adjusted p=0.01, after adjustment for the prespecified variables sex, birth weight and IVH grade). Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).ConclusionDRIFT is the first intervention for posthaemorrhagic ventricular dilatation to objectively demonstrate sustained cognitive improvement.Trial registration numberISRCTN80286058.

scholarly journals Ten-year follow-up of a randomised trial of drainage, irrigation and fibrinolytic therapy (DRIFT) in infants with post-haemorrhagic ventricular dilatation

2019 ◽  
Vol 23 (4) ◽  
pp. 1-116 ◽  
Author(s):  
Karen Luyt ◽  
Sally Jary ◽  
Charlotte Lea ◽  
Grace J Young ◽  
David Odd ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Treatment Group ◽  
Standard Treatment ◽  
Cost Effective ◽  
Fibrinolytic Therapy ◽  
Decision Analysis Model ◽  
Cognitive Disability ◽  
Analysis Model ◽  
Standard Treatment Group

Background The drainage, irrigation and fibrinolytic therapy (DRIFT) trial, conducted in 2003–6, showed a reduced rate of death or severe disability at 2 years in the DRIFT compared with the standard treatment group, among preterm infants with intraventricular haemorrhage (IVH) and post-haemorrhagic ventricular dilatation. Objectives To compare cognitive function, visual and sensorimotor ability, emotional well-being, use of specialist health/rehabilitative and educational services, neuroimaging, and economic costs and benefits at school age. Design Ten-year follow-up of a randomised controlled trial. Setting Neonatal intensive care units (Bristol, Katowice, Glasgow and Bergen). Participants Fifty-two of the original 77 infants randomised. Interventions DRIFT or standard therapy (cerebrospinal fluid tapping). Main outcome measures Primary – cognitive disability. Secondary – vision; sensorimotor disability; emotional/behavioural function; education; neurosurgical sequelae on magnetic resonance imaging; preference-based measures of health-related quality of life; costs of neonatal treatment and of subsequent health care in childhood; health and social care costs and impact on family at age 10 years; and a decision analysis model to estimate the cost-effectiveness of DRIFT compared with standard treatment up to the age of 18 years. Results By 10 years of age, 12 children had died and 13 were either lost to follow-up or had declined to participate. A total of 52 children were assessed at 10 years of age (DRIFT, n = 28; standard treatment, n = 24). Imbalances in gender and birthweight favoured the standard treatment group. The unadjusted mean cognitive quotient (CQ) score was 69.3 points [standard deviation (SD) 30.1 points] in the DRIFT group compared with 53.7 points (SD 35.7 points) in the standard treatment group, a difference of 15.7 points, 95% confidence interval (CI) –2.9 to 34.2 points; p = 0.096. After adjusting for the prespecified covariates (gender, birthweight and grade of IVH), this evidence strengthened: children who received DRIFT had a CQ advantage of 23.5 points (p = 0.009). The binary outcome, alive without severe cognitive disability, gave strong evidence that DRIFT improved cognition [unadjusted odds ratio (OR) 3.6 (95% CI 1.2 to 11.0; p = 0.026) and adjusted OR 10.0 (95% CI 2.1 to 46.7; p = 0.004)]; the number needed to treat was three. No significant differences were found in any secondary outcomes. There was weak evidence that DRIFT reduced special school attendance (adjusted OR 0.27, 95% CI 0.07 to 1.05; p = 0.059). The neonatal stay (unadjusted mean difference £6556, 95% CI –£11,161 to £24,273) and subsequent hospital care (£3413, 95% CI –£12,408 to £19,234) costs were higher in the DRIFT arm, but the wide CIs included zero. The decision analysis model indicated that DRIFT has the potential to be cost-effective at 18 years of age. The incremental cost-effectiveness ratio (£15,621 per quality-adjusted life-year) was below the National Institute for Health and Care Excellence threshold. The cost-effectiveness results were sensitive to adjustment for birthweight and gender. Limitations The main limitations are the sample size of the trial and that important characteristics were unbalanced at baseline and at the 10-year follow-up. Although the analyses conducted here were prespecified in the analysis plan, they had not been prespecified in the original trial registration. Conclusions DRIFT improves cognitive function when taking into account birthweight, grade of IVH and gender. DRIFT is probably effective and, given the reduction in the need for special education, has the potential to be cost-effective as well. A future UK multicentre trial is required to assess efficacy and safety of DRIFT when delivered across multiple sites. Trial registration Current Controlled Trials ISRCTN80286058. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 4. See the NIHR Journals Library website for further project information. The DRIFT trial and 2-year follow-up was funded by Cerebra and the James and Grace Anderson Trust.

scholarly journals Continuous warfarin administration versus heparin bridging therapy in post colorectal polypectomy haemorrhage: a study protocol for a multicentre randomised controlled trial (WHICH study)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yasuaki Nagami ◽  
Taishi Sakai ◽  
Masafumi Yamamura ◽  
Masami Nakatani ◽  
Takayuki Katsuno ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Anticoagulant Therapy ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Postoperative Bleeding ◽  
Endoscopic Polypectomy ◽  
Bleeding Rate ◽  
Randomised Controlled ◽  
Bridge Therapy

Abstract Background Endoscopic removal of colorectal adenoma is considered an effective treatment for reducing the mortality rates associated with colorectal cancer. Warfarin, a type of anticoagulant, is widely used for the treatment and prevention of thromboembolism; however, bleeding may increase with its administration after polypectomy. In recent times, a high incidence of bleeding after endoscopic polypectomy has been reported in patients receiving heparin bridge therapy. However, previous studies have not compared the bleeding rate after endoscopic colorectal polypectomy between patients who continued with anticoagulant therapy and those who received heparin bridge therapy. We hypothesised that endoscopic colorectal polypectomy under the novel treatment with continuous warfarin is not inferior to endoscopic colorectal polypectomy under standard treatment with heparin bridge therapy with respect to the rate of postoperative bleeding. This study aims to compare the efficacy of endoscopic colorectal polypectomy with continuous warfarin administration and endoscopic colorectal polypectomy with heparin bridge therapy with respect to the rate of postoperative bleeding. Methods We will conduct a prospective multicentre randomised controlled non-inferiority trial of two parallel groups. We will compare patients scheduled to undergo colorectal polypectomy under anticoagulant therapy with warfarin. There will be 2 groups, namely, a standard treatment group (heparin bridge therapy) and the experimental treatment group (continued anticoagulant therapy). The primary outcome measure is the rate of postoperative bleeding. On the contrary, the secondary outcomes include the rate of cumulative bleeding, rate of overt haemorrhage (that does not qualify for the definition of haemorrhage after endoscopic polypectomy), incidence of haemorrhage requiring haemostasis during endoscopic polypectomy, intraoperative bleeding during endoscopic colorectal polypectomy requiring angiography, abdominal surgery and/or blood transfusion, total rate of bleeding, risk factors for postoperative bleeding, length of hospital stay, incidence of thromboembolism, prothrombin time-international ratio (PT-INR) 28 days after the surgery, and incidence of serious adverse events. Discussion The results of this randomised controlled trial will provide valuable information for the standardisation of management of anticoagulants in patients scheduled to undergo colorectal polypectomy. Trial registration UMIN-CTR UMIN000023720. Registered on 22 August 2016

scholarly journals An effective app for self-management of urgency and mixed urinary incontinence in women: results from a randomised controlled trial (Preprint)

2020 ◽  
Author(s):  
Towe Wadensten ◽  
Emma Nyström ◽  
Karin Franzén ◽  
Anna Lindam ◽  
Elisabet Wasteson ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Mixed Urinary Incontinence ◽  
Self Management ◽  
Information Group ◽  
The Mean ◽  
Randomised Controlled

BACKGROUND Many women experience urgency and mixed urinary incontinence, but commonly hesitate to seek care. Treatment access and self-management can be supported through eHealth methods. OBJECTIVE This study investigated the efficacy of a mobile app for self-management of urgency and mixed urinary incontinence. METHODS This randomised controlled trial was conducted in Sweden. We included women of ≥18 year old, with urgency or mixed urinary incontinence and ≥2 leakages/week, excluding those with alarm symptoms. The women were recruited via information on TV, radio, and newspapers, and via Facebook advertisements. Initial selection was performed using a web-based screening questionnaire at our webpage. Data was then collected using an inclusion questionnaire and a two-day bladder diary. Symptom diagnosis was confirmed through a telephone interview. Participants were randomised to a treatment app (pelvic floor muscle training, bladder training, psychology, lifestyle advice, individual advice, statistics, reinforcement messages, and reminders) or brief information app (control). No guidance on the treatment was provided outside of the apps. The primary outcome was incontinence symptoms at follow-up (15 weeks), measured by ICIQ-UI SF score. Urgency symptoms were assessed via ICIQ-OAB score, and quality of life via ICIQ-LUTSqol score. Improvement was measured using Patient’s Global Impression of Improvement (PGI-I). These outcomes were patient reported. Cure was defined as no leakages (based on bladder diary). Intention-to-treat analysis was performed. RESULTS Between April 2017 and March 2018, 123 women were randomised to treatment (n=60, two lost to follow-up) or information (n=63). Of the included women, 28% had symptoms of urgency urinary incontinence, and 72% had mixed urinary incontinence. The mean age was 58.3 (SD 9.6) years and the majority had a university education. Half of the women were overweight or obese. Baseline characteristics did not differ between the two groups. The mean follow-up ICIQ-UI SF score was lower in the treatment group than the information group (estimated difference 3.1; 95% CI −4.8 to −1.3). For the follow-up ICIQ-OAB score, the estimated between-groups difference was −1∙8 (95% CI −2∙8 to −0∙99) and for the ICIQ-LUTSqol, the estimated between-groups difference was -6.3 (95% CI -10.5 to -2.1). Of women in the treatment group 90% reported an improvement, compared to 30% in the information group. Cure was reported by 19 women in the treatment group, and 4 in the control group (OR 5.38, 95% CI 1.86 to 15.57, p=0.002). During the 15-week treatment period, 69% of women in the treatment group used the app daily, and 10% used it at least three times per day. CONCLUSIONS The tested treatment app was effective for improvement and cure of urgency and mixed incontinence in women. It may be a good alternative to pharmacological treatment or other conservative management, increasing access to care. CLINICALTRIAL ClinicalTrials.gov NCT03097549

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