AzTrials
AzTrials

Intracerebral HemorrhagePhase 4I-CATCHERNCT06429332

International Care Bundle Evaluation in Cerebral Hemorrhage Research

A Phase 4 study testing Reversal of Oral anticoagulation within 30 minutes, Early intensive blood pressure lowering and Treatment of pyrexia in people with Intracerebral Hemorrhage and Intracerebral Haemorrhage, run by Region Skane at 54 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Spontaneous intracerebral haemorrhage (ICH) accounts for approximately 10-15% of all strokes but stands for 50% of stroke-related morbidity and mortality. Approximately half of all patients with ICH have a decreased level of consciousness at hospital admission. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Reversal of Oral anticoagulation within 30 minutes, Early intensive blood pressure lowering and Treatment of pyrexia
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,500 participants
Where
54 sitesin 8 countries
Study dates
7 Jan 2025to Jul 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (age ≥18 years)
  • Non-contrast computerized tomography (NCCT) imaging-verified diagnosis of spontaneous intracerebral haemorrhage
  • ≤24 hours from symptom onset or presumed symptom onset (last seen well)

Who cannot join

  • Previous care limitation
  • End-stage comorbidity with short life-expectancy (<6 m; e.g. terminal cancer)
  • ICH caused by brain tumor or cerebral venous thrombosis
  • Clinical signs of brain herniation at first presentation (unresponsive patient with bilaterally fixed, maximally dilated pupils)
  • Pregnant women beyond 22 weeks gestation may only be included after thorough discussion with an obstetrician to determine risks vs benefit.

Trial locations and contacts

54 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Teresa Ullberg, MD, PhD contact

0046175057

i-catcher@med.lu.se

Trine Apostolaki-Hansson, MD PhD contact

trine.apostolaki-hansson@med.lu.se

54 sites in 8 countries

Sweden38 sites, 38 recruiting

  • Höglandssjukhuset i Eksjö

    Eksjö, 575 81

    Melania Vass, 46102410000, melania.vass@rjl.se

    Recruiting

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

    Petra Redfors, MD, 46313421000, petra.redfors@vgregion.se

    Recruiting

  • Östra Sjukhuset

    Gothenburg, 41685

    Christina Heden Ståhl, 46313421000, christina.heden-stahl@vgregion.se

    Recruiting

  • Hässleholms Sjukhus

    Hässleholm

    Annika Nilsson, +451-29 63 30, Annika.AC.Nilsson@skane.se

    Magnus Esbjörnsson, MD

    Recruiting

  • Helsingborgs Lasarett

    Helsingborg

    Angela Persson, +424061895, angela.persson@skane.se

    Gustaf Westerberg, MD

    Recruiting

  • Karolinska Universitetssjukhuset Huddinge

    Huddinge

    Michael Mazya, MD, 4612380000, michael.mazya@regionstockholm.se

    Recruiting

  • Länssjukhuset Ryhov

    Jönköping, 551 85

    Veronica Gajdos, 46102422870, veronika.gajdos@rjl.se

    Recruiting

  • Länssjukhuset Kalmar

    Kalmar, 391 85

    Åsa Landerholm, MD, 46103580000, asa.landerholm@regionkalmar.se

    Recruiting

  • Blekingesjukhuset Karlskrona

    Karlskrona, 371 41

    Joseph Aked, MD PhD, 46455731000, joseph.aked@regionblekinge.se

    Recruiting

  • Blekingesjukhuset

    Karlskrona

    Katarina Widebrant, +455-73 10 53, katarina.widebrant@regionblekinge.se

    Håkan Johansson, MD PhD

    Recruiting

  • Centralsjukhuset Karlstad

    Karlstad, 651 85

    Felix Andler, MD, 46108315000, felix.andler@regionvarmland.se

    Recruiting

  • Västmanlands sjukhus Köping

    Köping, 731 81

    Tommie Jagestad, 4622126000, tommie.jagestad@regionvastmanland.se

    Recruiting

  • Centralsjukhuset Kristianstad

    Kristianstad

    Liliana-Alina Pasca, +44-309 11 03, liliana-alina.pasca@skane.se

    Jon Paradis

    Recruiting

  • Kungälvs sjukhus

    Kungälv, 442 83

    Monira Rasek, 4630398000, monira.rasekh@vgregion.se

    Recruiting

  • Univeristetssjukhuset Linköping

    Linköping, 581 85

    Avan Sabir Rashid, MD, 46101030000, avan.sabir.rashid@regionostergotland.se

    Recruiting

  • Ljungby Lasarett

    Ljungby, 341 35

    Bartosz Chlopicki, MD, PhD, 46372505000, bartosz.chlopicki@kronoberg.se

    Recruiting

  • Skåne University Hospital Lund Neurosurgery dept

    Lund

    Susanne Månsson, +46-17 12 18, susanne.e.mansson@skane.se

    Nathanael Göransson, MD

    Recruiting

  • Skåne University Hospital Lund

    Lund

    Dren Bashota, +46-17 12 84, dren.bashota@skane.se

    Gunnar Andsberg, MD PhD

    Recruiting

  • Region Skåne, Skåne University Hospital in Malmö, Department of Neurology

    Malmö, 20502

    Teresa Ullberg, MD, PhD, +4646175057, i-catcher@med.lu.se

    Trine Apostolaki-Hansson, MD PhD

    Recruiting

  • Mölndals Sjukhus

    Mölndal, 431 80

    Linda Karlsson Lindahl, PhD, 46313433100, linda.karlsson.lindahl@vgregion.se

    Recruiting

  • Universitetssjukhuset Örebro

    Örebro, 701 85

    Kristin Hellfeldt, 461960210, kristin.hellfeldt@regionorebrolan.se

    Recruiting

  • Oskarshamn Sjukhus

    Oskarshamn, 572 28

    Bongomin Churchill Otto, MD, 46103580000, bongomin.otto@regionkalmar.se

    Recruiting

  • Östersunds Lasarett

    Östersund

    Linda Wiklund, +63153008, linda.wiklund@regionjh.se

    Joachim Ögren, MD PhD

    Recruiting

  • Skaraborgs Sjukhus Skövde

    Skövde, 541 85

    Alexander Johansson, 46500431000, alexander.p.johansson@vgregion.se

    Recruiting

  • Capio St Görans Sjukhus

    Stockholm, 112 81

    Nina Moeini, 46858701000, nina.moeini@capiostgoran.se

    Recruiting

  • Södersjukhuset

    Stockholm, 118 83

    Oana Romanitan, MD, PhD, 46812361000, mihaela.romanitan@regionstockholm.se

    Recruiting

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76

    Michael Mazya, MD, 46812370000, michael.mazya@regionstockholm.se

    Recruiting

  • Danderyds sjukhus

    Stockholm, 182 88

    Magnus Thorén, MD PhD, 46812355000, magnus.thoren@regionstockholm.se

    Recruiting

  • Länssjukhuset Sundsvall

    Sundsvall

    Elizabeth Morena Fors, +60-18 10 00, elizabeth.morena.fors@rvn.se

    Vincy Eklöf, MD PhD

    Recruiting

  • Norra Älvsborgs Länssjukhus

    Trollhättan, 461 85

    Peter Puhlmann, MD, 46104350000, peter.puhlmann@vgregion.se

    Recruiting

  • Norrlands Universitetssjukhus

    Umeå

    Mariann Haapalahti, +90-785 00 00, mariann.haapalahti@regionvasterbotten.se

    Johan Birnefeld, MD

    Recruiting

  • Lasarettet i Enköping

    Uppsala, 751 85

    Gjorgi Mihajlovski, MD, 46171418000, gjorgi.mihajlovski@regionuppsala.se

    Recruiting

  • Akademiska Sjukhuset Uppsal

    Uppsala, 75185

    Signild Åsberg, MD, PhD, 46186110000, signild.asberg@medsci.uu.se

    Recruiting

  • Hallands sjukhus Varberg

    Varberg, 43237

    Rubincho Milenkoski, MD, 46340481000, Rubincho.Milenkoski@regionhalland.se

    Recruiting

  • Värnamo sjukhus

    Värnamo, 331 85

    Felicia Morar, 46102410000, felicia.morar@rjl.se

    Recruiting

  • Västerås

    Västerås, 721 89

    Per Lenngren, 4621173000, per.lenngren.hysing@regionvastmanland.se

    Recruiting

  • Centrallasarettet Växjö

    Vaxjo

    Anette Borland, +470-58 80 00, anette.borland@kronoberg.se

    Johan Weber, MD

    Recruiting

  • Ystads lasarett

    Ystad

    Lovisa Åhlin Billeskalns, +411-99 52 92, lovisa.billeskalns@skane.se

    Martin Ekdahl, MD

    Recruiting

Other trials in Sweden

Italy5 sites, 5 recruiting

  • Avezzano Ospedale SS. Filippo e Nicola

    Avezzano, 67051

    Simona Sacco, MD, +39 0863 4991, simona.sacco@univaq.it

    Raffaele Ornello, MD

    Recruiting

  • Citta di Castello Ospedale Città di Castello

    Città di Castello, 06012

    Silvia Cenciarelli, MD, +39 075 8932278, silvia.cenciarelli@uslumbria1.it

    +39 075 9270801

    Recruiting

  • Gubbio Ospedale di Gubbio e Gualdo Tadino

    Gubbio, Italy

    Tatiana Mazzoli, MD, +39 075 5411, tatiana.mazzoli@uslumbria1.it

    Recruiting

  • Azienda Ospedaliera Santa Maria della Misericordia Perugia

    Perugia, 06129

    Alessandro Bufi, MD, +39 075 5782266, alessandro.bufi147@gmail.com

    Valeria Caso

    Recruiting

  • Roma Policlinico Gemelli

    Roma, 00136

    Giovanni Frisullo, MD, +39 06 30151, Giovanni.frisullo@policlinicogemelli.it

    Recruiting

Other trials in Italy

Australia3 sites, 3 recruiting

  • Royal Adelaide Hospital

    Adelaide, 5000

    Timothy Kleinig, Prof, +61 8 7074 2903, Timothy.Kleinig@sa.gov.au

    Recruiting

  • Monash Medical Centre

    Clayton, 3168

    Henry Ma, Prof, +61 3 8572 2131, Henry.Ma@monashhealth.org

    Recruiting

  • The George Institute for Global Health

    Sydney, NSW 2000

    Menglu Ouyang, PhD, MPH, 0061280524808, mouyang@georgeinstitute.org.au

    Menglu Ouyang, PhD, MPH

    Not yet recruiting

Other trials in Australia

Canada3 sites, 3 recruiting

  • Health Sciences North/Health Sciences North Research Institute

    Greater Sudbury, Ontario, P3E 5J1

    Ravinder Singh, MD, 705-523-7300 ext. 1932, ravsingh@hsnsudbury.ca

    Recruiting

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

    Aristeidis Katsanos, MD, PhD, 905-521-2100 ext. 44132, Aristeidis.Katsanos@phri.ca

    Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1Y 4E9

    Dar Dowlatshahi, MD PhD FRCPC, +1 613-761-4709, ddowlat@toh.ca

    Recruiting

Other trials in Canada

Malaysia2 sites, 2 recruiting

  • National University of Malaysia Hospital

    Kuala Lumpur, 56000

    Zhe Kang Law, MD MRCP FRCP PhD, +601126384288, zhe.kanglaw@hctm.ukm.edu.my

    Recruiting

  • Universiti Putra Malaysia Hospital

    Serdang, 43400

    Abdul Hanif Khan Bin Yusof Khan, MD, +60192671685, ahanifkhan@upm.edu.my

    Recruiting

Other trials in Malaysia

United States1 site, 1 recruiting

  • The University of Oklahoma Health

    Oklahoma City, Oklahoma, 73126-0901

    Faddi G. Saleh Velez, MD, 405-271-4113, Faddi-SalehVelez@ou.edu

    Recruiting

Other trials in United States

Hong Kong1 site, 1 recruiting

  • Hong Kong University Hospital

    Hong Kong

    Kay Cheong Teo, MD, (+852) 2255 3749, kcteo@hku.hk

    Recruiting

Other trials in Hong Kong

Iceland1 site, 1 recruiting

  • Landspitali University Hospital

    Reykjavik, 105

    Björn Logi Þórarinsson, MD MSc FESO, +354 8253850

    Recruiting

Other trials in Iceland

About this study

Official title: International Care Bundle Evaluation in Cerebral Hemorrhage Research - a Batched Parallel Cluster-randomized Trial With a Baseline Period

Spontaneous intracerebral haemorrhage (ICH) accounts for approximately 10-15% of all strokes but stands for 50% of stroke-related morbidity and mortality. Approximately half of all patients with ICH have a decreased level of consciousness at hospital admission. Despite this, intensive care and neurosurgical interventions are uncommon. A study conducted in low- and middle-income countries has demonstrated a beneficial effect of a treatment package consisting of early intensive blood pressure lowering, as well as the treatment of pyrexia and elevated blood glucose levels. The I-CATCHER team is now planning to conduct a similar study in Sweden and Australia, as well as in other high-income countries. The study has a clear focus on implementation, aiming to improve treatment and prognosis for patients with ICH within a few years. The purpose of I-CATCHER is to investigate whether a structured treatment package (Care Bundle) improves 3-month prognosis in patients with spontaneous ICH compared to standard care.

Read the detailed description

Spontaneous intracerebral hemorrhage (ICH) accounts for 10 to 15% of all strokes in high-income countries (HIC), and nearly twice this number in low-income to upper-middle-income countries (LMIC) (29.5%). It is the most devastating type of stroke given the high one-month case fatality of approximately 30-40%, and only 12-39% suffer persistent disability.

Despite several advances in the management of acute ischemic stroke supported by numerous randomized controlled trials (RCT), progress in establishing novel interventions to improve outcomes for ICH has been slow. Still today, the diagnosis of ICH evokes pessimism among treating physicians, and patients may be withheld guideline adherent treatment for this reason. This nihilistic approach is presumably due to an over-estimation of poor outcome, often influenced by the neurologically devastating features commonly present at ICH admission. Additionally, the scarcity of RCTs providing strong evidence for treatment recommendations may contribute to a more reluctant approach in the acute setting of ICH, particularly when presenting with debilitating symptoms.

The third INTEnsive care bundle with BP reduction in acute cerebral hemorrhage trial (INTERACT3) was recently published in 2023. This trial employed a stepped wedge cluster RCT design to evaluate the implementation of a Care Bundle protocol. This comprehensive protocol included early intensive BP lowering (EIBPL), management of pyrexia and hyperglycemia, and the early reversal of OAC treatment. The design of this trial drew inspiration from a post-hoc analysis of the INTERACT2 study that showed that the scoring of abnormal baseline variables, interventions included in the future INTERACT3 Care Bundle, independently predicted a poor functional outcome following ICH. The implementation of the time sensitive bundle of care in INTERACT3 resulted in an improved functional outcome at 6 months following ICH. However, as the trial included patients predominantly from LMIC, further studies are warranted to determine if these results are applicable to HIC with a more applicable Care Bundle for these populations. An earlier intervention study from the United Kingdom, published in 2019, studied a similar 'quality improvement' acute Care Bundle. This Care Bundle aimed to improve the speed of treatment delivery, access to acute care, and decrease case fatality following ICH. Despite certain limitations, including a non-randomized design, this study demonstrated significantly lower mortality rates in patients receiving the Care Bundle versus the pre-implementation standard of care.

I-CATCHER is an international, multicenter, batched, parallel, cluster, randomized clinical trial (RCT) to assess a multifaceted package of protocols in a broad range of patients with acute ICH. In each batch, hospitals will be randomized into two groups according to the timing of the intervention (Care Bundle) over 3 phases (phase 1: usual care, phase 2: randomized evaluation - to intervention or usual care, phase 3: post-implementation follow-up - all hospitals implement the intervention). This design will capture consecutive patients with ICH and allow continued intervention in perpetuity as more hospitals join. Compared to a conventional stepped-wedge cluster RCT, the intervention effect in this design is less likely to be confounded by background temporal trends as only baseline and parallel comparison data (first 2 periods in bold black frame) are used to determine the effectiveness of the Care Bundle. All hospitals will be exposed to the Care Bundle which allows assessment of sustainability and integration of the intervention into routine practice. Each batch period is 18 months (6 months per phase); whole study will be rolled out in 2.5 years.

This design involves implementation of an intervention package applied to all patients with ICH as part of routine care. Patients are only excluded if they refuse to have details of their management included and/or participate in follow-up procedures.

Study site inclusion criteria: Organized systems of acute stroke care; no established comprehensive protocols for the management of ICH; suitable location, infrastructure and willingness to participate in clinical research; suitable numbers of ICH patients (at least 30 per year).

Patient inclusion criteria: Adults (≥18 years) with spontaneous ICH confirmed by imaging and admitted hospital within 24 hours of the onset of symptoms.

Being tested
Reversal of Oral anticoagulation within 30 minutes, Early intensive blood pressure lowering, Treatment of pyrexia, Hyperglycemia treatment, Do-not-resuscitate (DNR) or withdrawal of care
Keywords
intracerebral hemorrhage, oral anticoagulant, blood pressure lowering, early intensive blood pressure lowering, care bundle, implementation study, reversal treatment, outcome, UW-mRS, Modified Rankin Scale
Medical subject headings
Cerebral Hemorrhage, Stroke, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reversal of Oral anticoagulation within 30 minutesOther

    Also called OAC reversal

    In situations of either an elevated INR with the use of warfarin - treatment with either 3- or 4-factor prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP) within 30 minutes of ICH diagnosis on NCCT to reach and maintain an INR target <1.3; or where there has been recent use (<48 hours) of a direct oral anticoagulant (DOAC), use of an appropriate reversal agent within 30 minutes, where available, and according to local approvals.

  • Early intensive blood pressure loweringOther

    A systolic blood pressure (BP) target of 130-140 mmHg within 30 minutes of ICH diagnosis on NCCT is strived for, and to maintain this BP level for the first 7 days (for patients presenting with blood pressure <200 mmHg). If blood pressure ≥200 and <220, a target BP of 160 mmHg should be targeted at 30 minutes, and 130-140 mmHg should be achieved in 60 minutes. If BP ≥220, target BP of 160 mmHg and should be achieved in 60 minutes.

  • Treatment of pyrexiaOther

    To achieve a body temperature target <37.5 °C within the first 24h following ICH diagnosis on NCCT

  • Hyperglycemia treatmentOther

    To maintain a blood glucose level 7-10 mmol/L within the first 24h following ICH diagnosis on NCCT

  • Do-not-resuscitate (DNR) or withdrawal of careOther

    Refrain from the use of DNR or withdrawal of care orders for 48 hours

  • Referral to Intensive CareOther

    Immediate (<30 min) referral to intensive care if airway, breathing and/or circulation are compromized

  • Referral to NeurosurgeryOther

    Immediate (<30 min) referral to neurosurgery if any of the following criteria are fulfilled:

    • Large and/or rapidly evolving supratentorial ICH (>20 ml volume)
    • Any intraventricular extension
    • Posterior fossa bleed, irrespective of volume
    • Suspicion of a vascular malformation, independent of volume or location
    • Reduction in reaction to sensory stimulation or drowsiness

  • Repeat brain imagingDiagnostic test

    Repeat 6-12-hour brain imaging with the physicians choice of modality, preferably computed tomography (CT), if clinical deterioration or the patient received OAC reversal treatment

  • Standard careOther

    For patients in the usual-care group, decisions about the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team. Data will be collected regarding the management of patients, including insertion of invasive monitoring devices, intravenous fluid resuscitation, BP lowering, vasoactive support, glycemic control, mechanical ventilation, neurosurgery, and other supportive therapy.

Study groups in NCT06429332
Study groupRoleWhat they receive
Intervention groupActive comparatorA range of implementation methods will be used to introduce an active Care Bundle with time- and target-based metrics that involve the rapid correction of abnormal physiological variables over days or hospital discharge (or death, if sooner) and referral pathways
Receives: Other: Reversal of Oral anticoagulation within 30 minutes; Other: Early intensive blood pressure lowering; Other: Treatment of pyrexia; Other: Hyperglycemia treatment; Other: Do-not-resuscitate (DNR) or withdrawal of care; Other: Referral to Intensive Care; Other: Referral to Neurosurgery; Diagnostic Test: Repeat brain imaging
Usual carePlacebo comparatorFor patients in the usual-care group, decisions about the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team. Data will be collected regarding the management of patients, including insertion of invasive monitoring devices, intravenous fluid resuscitation, BP lowering, vasoactive support, glycemic control, mechanical ventilation, neurosurgery, and other supportive therapy.
Receives: Other: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of functional outcome based on the Utility Weighted modified Rankin Scale score

    The modified Rankin Scale (mRS) is an efficient, reliable, and simple functional outcome measure widely used as a primary endpoint in clinical trials for acute stroke. However, being an ordered categorical scale, it may not reflect potentially unequal differences in perceived quality of life associated with certain 1-point shifts vs others. Utility-weighted mRS is a score that weighs the mRS against a health utility scale, which defined as the desirability of a specific health outcome, facilitates comparisons of health-related quality of life across an array of clinical settings. Utility weights, as referred to hereafter, reflect the spectrum between perfect health (a score of 1) and outcomes worse than death (where death is a score of 0 and negative values indicate an outcome worse than death). The primary outcome is UW-mRS at 3 months and will be analyzed by means of a linear regression, with mRS as a dependent variable with 7 levels (0 [no residual symptom] to 6 [death]).

    Measured: 180±30 days

Secondary outcomes (4)

  1. Ordinal shift analysis of mRS

    The assessment of shifts in the distribution of mRS scores through the evaluation of scores in ordinal groups

    Measured: 180 days±30 days

  2. Assessment of health-related quality of life (HRQoL)

    This will be assessed using the EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D). The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: 180 days±30 days

  3. Poor outcome defined as mRS 3-6

    Binary secondary outcomes will be analyzed by means of standard GEE or random-effects regression with a logistic link and/or time-to-event type endpoints using the Cox model with a sandwich formula or a frailty model.

    Measured: 180 days±30 days

  4. Separate outcomes for death and disability

    Binary secondary outcomes will be analyzed by means of standard GEE or random-effects regression with a logistic link and/or time-to-event type endpoints using the Cox model with a sandwich formula or a frailty model.

    Measured: 180 days±30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2024
  2. Study start7 Jan 2025
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
international multicentre, batched, cluster. Patients are not randomized, hospitals will be randomized. In each batch, hospitals are randomized into two groups according to the timing of the intervention (Care Bundle) over 3 phases (usual care, randomized evaluation, post-implementation follow-up): Phase 1 - baseline routine data collection, training and formative study (assess context and local resources, support adjustment of the protocol into local pathways) Phase 2 - start intervention implementation in the intervention group, data collection for comparison with usual care in the control group Phase 3 - all hospitals implement the intervention, data collection for quality improvement, assess sustainability and integration
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06429332
Sponsor's protocol ID
2024-02523-01
Acronym
I-CATCHER
Status last verified
May 2025
First submitted
14 May 2024
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.

    PubMed 34487721

  • Qureshi AI, Tuhrim S, Broderick JP, Batjer HH, Hondo H, Hanley DF. Spontaneous intracerebral hemorrhage. N Engl J Med. 2001 May 10;344(19):1450-60. doi: 10.1056/NEJM200105103441907. No abstract available.

    PubMed 11346811

  • van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.

    PubMed 20056489

  • Parry-Jones AR, Sammut-Powell C, Paroutoglou K, Birleson E, Rowland J, Lee S, Cecchini L, Massyn M, Emsley R, Bray B, Patel H. An Intracerebral Hemorrhage Care Bundle Is Associated with Lower Case Fatality. Ann Neurol. 2019 Oct;86(4):495-503. doi: 10.1002/ana.25546. Epub 2019 Aug 16.

    PubMed 31291031

  • Hemphill JC 3rd, Newman J, Zhao S, Johnston SC. Hospital usage of early do-not-resuscitate orders and outcome after intracerebral hemorrhage. Stroke. 2004 May;35(5):1130-4. doi: 10.1161/01.STR.0000125858.71051.ca. Epub 2004 Mar 25.

    PubMed 15044768

  • Becker KJ, Baxter AB, Cohen WA, Bybee HM, Tirschwell DL, Newell DW, Winn HR, Longstreth WT Jr. Withdrawal of support in intracerebral hemorrhage may lead to self-fulfilling prophecies. Neurology. 2001 Mar 27;56(6):766-72. doi: 10.1212/wnl.56.6.766.

    PubMed 11274312

  • Zahuranec DB, Brown DL, Lisabeth LD, Gonzales NR, Longwell PJ, Smith MA, Garcia NM, Morgenstern LB. Early care limitations independently predict mortality after intracerebral hemorrhage. Neurology. 2007 May 15;68(20):1651-7. doi: 10.1212/01.wnl.0000261906.93238.72.

    PubMed 17502545

  • Song L, Hu X, Ma L, Chen X, Ouyang M, Billot L, Li Q, Munoz-Venturelli P, Abanto C, Pontes-Neto OM, Antonio A, Wasay M, Silva A, Thang NH, Pandian JD, Wahab KW, You C, Anderson CS; INTERACT3 investigators. INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial. Trials. 2021 Dec 20;22(1):943. doi: 10.1186/s13063-021-05881-7.

    PubMed 34930428

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Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Reversal of Oral anticoagulation within 30 minutes, Early intensive blood pressure lowering and Treatment of pyrexia in people with Intracerebral Hemorrhage and Intracerebral Haemorrhage, run by Region Skane at 54 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Sweden, Italy, Australia, Canada, Malaysia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Teresa Ullberg, MD, PhD (0046175057, i-catcher@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of functional outcome based on the Utility Weighted modified Rankin Scale score (time frame: 180±30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06429332, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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