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The third, INTEnsive care bundle with blood pressure Reduction in Acute Cerebral haemorrhage Trial

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SLCTR Registration Number

SLCTR/2021/003


Date of Registration

24 Jan 2021

The date of last modification

Jan 25, 2021



Application Summary


Scientific Title of Trial

The third, INTEnsive care bundle with blood pressure Reduction in Acute Cerebral haemorrhage Trial


Public Title of Trial

An investigator initiated international, multicentre, stepped wedge cluster randomised study of a care bundle of physiological control strategies in acute intracerebral haemorrhage patients in comparison to usual care


Disease or Health Condition(s) Studied

Acute spontaneous intracerebral haemorrhage


Scientific Acronym

INTERACT3


Public Acronym

INTERACT3


Brief title

The Third, Intensive Care Bundle With Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial


Universal Trial Number

U1111-1257-1704


Any other number(s) assigned to the trial and issuing authority

Clinicaltrials.gov (NCT03209258) Chinese Trial Registry (ChiCTR-IOC-17011787) ERC P/49/08/2020


Trial Details


What is the research question being addressed?

How effective will a goal-directed care bundle of active management involving early physiological control (intensive blood pressure [BP] lowering, glycemic control, and early treatment of pyrexia) and reversal of anticoagulation be on functional outcome in patients with acute spontaneous intracerebral haemorrhage (ICH). versus usual standard of care?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 4


Intervention(s) planned

Study Settings include the following: • National Hospital of Sri Lanka • Colombo South Teaching Hospital • Kurunegala Teaching Hospital • Karapitiya Teaching Hospital • Jaffna Teaching Hospital • Kandy National Hospital

Randomization method: The unit of randomisation is the hospital site; randomly assigned by a statistician. Participating sites will be stratified according to country and size of site. When the site is ready, they will be notified of the randomised group within 2 weeks of an agreed date of commencing the study.

Intervention: All patients will receive continuous noninvasive cardiac monitoring, including ECG, oxygen saturation, heart rate and arterial blood pressure. Routine laboratory tests will be performed on admission and at least once during the following 7 days; in the case of significant abnormalities, they were taken daily. Goal-directed care bundle of active management group will include;

  1. Early intensive BP lowering. The aim is to achieve a systolic BP level <140mmHg within 1 hour of treatment and to maintain this BP level for the next 7 days or hospital discharge should this occur earlier. Intravenous BP lowering is to commence as soon as possible upon admission. If systolic blood pressure (SBP) ? 140 mmHg and heart rate (HR) > 55 bpm, repeat labetalol 10 mg bolus in 5 minutes. labetalol 20 mg IV push q 5 mins until target SBP reached (< 140mmHg) or HR <55 bpm; increase to 40 mg bolus if required. Maximum labetalol dose: 300 mg / 24 hours
  2. Intensive glucose control. The aim is to achieve a target blood glucose level of 6.1-7.8 mmol/l for non-diabetic patients and 7.8-10.0mmol/l for diabetic patients and to maintain this blood glucose level for the next 7 days or hospital discharge should this occur earlier. At the time of admission, blood glucose level and HbA1C will be tested in all patients. Patients with increased HbA1C will be diagnosed as diabetics, undiagnosed diabetics, or pre-diabetics. In the intensive-treatment group, a continuous infusion of insulin (50IU in 50ml of 0.9% sodium chloride with the use of a pump) should be started as soon as possible if the blood glucose level exceeded 7.8mmol/l in non-diabetics and 10mmol/l in diabetics. The infusion adjusted to maintain the level at a value between 6.1 and 7.8mmol/l for non-diabetics, and 7.8 and 10.0mmol/l for diabetics.
  3. Treatment of pyrexia. The aim is to achieve a core body temperature level <37.5? within 1 hour of treatment and to maintain this temperature level for the next 7 days or hospital discharge should this occur earlier. Measurement of temperature is according to standard practice. Patients allocated to intensive group will receive measurement of body temperature every 4 hours with 72 hours after admission. Patients with an increase in body temperature to ?37.5? will commence fever treatment immediately. At level 1 and 2 patients will receive a single drug of 500 mg of paracetamol (oral or rectal). In cases of nonresponse to antipyretic drugs, external cooling with calf packing was applied for 60 min at level 3, and finally an intravenous infusion of 500 ml of cooled (4 ?) saline (0.9% NaCl) over 30 min is performed at level 4. The last step is reserved for patients without clinical signs of congestive heart failure or a history of dyspnea. Measurement of body temperature is performed 60 min after the patient entered each level. Body temperature ?37.5 ? after completion of the last step resulted in a drop back to initial management (with paracetamol). The procedure is limited treatment to a maximum of 4 complete cycles within 24 hours.
  4. Reversal of anticoagulation. The aim is to achieve INR<1.5 within 1 hour of treatment and to maintain this level for the next 7 days or hospital discharge should this occur earlier. All patients with suspicious ICH should be checked blood INR immediately. Those allocated to intensive group with elevated INR (>1.5) should be given 20 mL/kg of intravenous FFP (after blood group typing or by using AB group plasma supplied by local transfusion units) or 30 IU/kg of intravenous four-factor PCC according to hospital applicability within 1 hour after diagnosis; 5-10 mg of vitamin K will also be administered intravenously and slowly. The speed of the infusion of FFP or PCC should be as fast as the condition of the patient would allow. Patients with an INR greater than 1?5 at 3 h after the start of treatment received PCC (if INR?2.0, 10 IU/kg; if INR>2.0, 30IU/kg) as a rescue treatment. INR should be checked at regular intervals.

Control Group: Usual care- Patients will receive the usual management based on local guidelines and hospital's individual policy.


Inclusion criteria

• Age >= 18 (both male and female) • Acute stroke syndrome that is due to presumed spontaneous ICH, confirmed by clinical history and a CT scan within 6 hours of stroke onset without/without contrast, and if an CT angiogram is also undertaken as part of routine care. • Presentation to hospital within 6 hours of stroke onset


Exclusion criteria

• Definite evidence that the ICH is secondary to a structural abnormality in the brain (eg an AVM, intracranial aneurysm, tumour, trauma, or previous cerebral infarction) or previous thrombolysis. • A high likelihood that the patient will not adhere to the study treatment and follow-up regimen. In each case, the decision about the patient’s eligibility will be based on the attending clinician’s interpretation of the above eligibility criteria



Primary outcome(s)

1.

Functional recovery according to an ordinal shift analysis of the full range of scores on the modified Rankin scale (mRS) scores at 6 months

[

6 Months

]

Secondary outcome(s)

1.

Functional recovery according to a shift analysis of scores on the National Institutes of Health Stroke Scale (NIHSS) at 7 days. The following at 6-months: poor outcome defined by mRS scores of 3-6; separately on death and disability (mRS 3-5); health-related quality of life (HRQoL) using the EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D); duration of hospitalisation; and residence.

[

6 months

]

Target number/sample size

300 out of 8360 (150 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2021-01-25


Anticipated end date

2022-11-18


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

The West China Hospital Outstanding Discipline Development 1-3-5 Program (ZY2016102) • Program Grant from the National Health and Medical Research Council (NHMRC) of Australia (APP1149987) • Funding is also from Sichuan Credit Pharmaceutical CO., LTD


Regulatory approvals

N/A



State of Ethics Review Approval


Status

Approved


Date of Approval

2020-12-10


Approval number

P/49/08/2020


Details of Ethics Review Committee

Name: Ethics Review Committee Name- University of Kelaniya
Institutional Address: Ethics Review Committee Name- University of Kelaniya Institutional Address Ethics- Ethics- Review Committee, Faculty of Medicine, University of Kelaniya
Telephone:011-2961267
Email: ercmed@kln.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr.Bimsara Senanayake
Consultant Neurologist
National Hospital of Sri-Lanka Colombo 10
0113618756
0773046096

bimsaras@sltnet.lk

Contact Person for Public Queries

Dr.Bimsara Senanayake
Consultant Neurologist
National Hospital of Sri-Lanka Colombo 10
0113618756
0773046096

bimsaras@sltnet.lk


Primary study sponsor/organization

The George Institute for Global Health (Australia) Beijing Representative Office





Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results