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02 September 2010
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| [ Print-friendly version ] |
| Thrombolysis Register of Acute Ischaemic Stroke in China |
| ISRCTN | ISRCTN69801104 |
| ClinicalTrials.gov identifier | |
| Public title | Thrombolysis Register of Acute Ischaemic Stroke in China |
| Scientific title | |
| Acronym | TRAIS-CHINA |
| Serial number at source | 5 |
| Study hypothesis |
1. To evaluate the clinical status of recombinant tissue Plasminogen Activator (rt-PA) thrombolysis in acute ischaemic stroke (within a three-hour time-window) in China
2. To assess whether the safety and efficacy of thrombolysis in acute ischaemic stroke are equivalent in the settings of randomised controlled trials and during implementation into clinical routine in China |
| Ethics approval | Approval gained from the Beijing Tiantan Hospital Capital Medical University Ethics Board on October 10, 2006. |
| Study design | An open, prospective, multicentre, non-randomised observational study |
| Countries of recruitment | China |
| Disease/condition/study domain | Acute ischaemic stroke |
| Participants - inclusion criteria |
1. Female or male inpatients
2. Age 18 to 80 years 3. Clinical diagnosis of ischaemic stroke 4. Onset of symptoms within three hours prior to initiation of thrombolysis treatment 5. Stroke symptoms present for at least 30 minutes and has not significantly improved before treatment 6. Patients are willing to receive thrombolysis treatment and to give informed consent 7. Patients are willing and able to comply with the study protocol |
| Participants - exclusion criteria |
1. Evidence of Intracranial Haemorrhage (ICH), brain tumours, vascular malformation, aneurysm, Subarachnoid Haemorrhage (SAH) or major early infarct signs involving greater than 1/3 of Middle Cerebral Artery (MCA) territory on the Computed Tomography (CT)-scan
2. Severe stroke as assessed clinically (e.g. National Institutes of Health Stroke Scale [NIHSS] greater than 25) and/or by appropriate imaging techniques 3. Seizure at onset of stroke 4. Prior stroke within the last three months 5. Patients with any history of prior stroke and concomitant diabetes 6. Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory 7. Platelet count of below 100,000/mm^3 8. Uncompensated hypertension at study entry or hypertension requiring aggressive treatment to reduce blood pressure to nonhypertensive limits. Uncompensated hypertension is defined as systolic blood pressure greater than 185 mmHg or diastolic blood pressure greater than or equal to 110 mmHg on three repeated measures at least 10 minutes apart 9. Blood glucose less than 50 or greater than 400 mg/dl 10. Known haemorrhagic diathesis within the last six months 11. Patients receiving oral anticoagulants, e.g., warfarin sodium, and International Normalised Ratio (INR) greater than 1.5 12. Known history of or suspected intracranial haemorrhage including subarachnoid haemorrhage 13. Pregnancy or lactation 14. Any history of severe central nervous system damage (i.e., neoplasm, aneurysm, intracranial or spinal surgery) 15. Haemorrhagic retinopathy, e.g., in diabetes (vision disturbances may indicate haemorrhagic retinopathy) 16. Bacterial endocarditis, pericarditis 17. Prolonged traumatic external heart massage, or recent (less than 10 days) obstetrical delivery or recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture) 18. Acute pancreatitis 19. Documented ulcerative gastrointestinal disease during the last three months 20. Oesophageal varices, arterial-aneurysm, arterial/venous malformation 21. Neoplasm with increased bleeding risk 22. Severe liver disease, including hepatic failure, cirrhosis, portal hypertension oesophageal varices) and active hepatitis 23. Major surgery or significant trauma in past 10 days 24. Known serious sensitivity to Alteplase |
| Anticipated start date | 01/04/2007 |
| Anticipated end date | 01/06/2010 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 330 |
| Interventions | All patients will be given intravenous (i.v.) rt-PA 0.9 mg/kg body weight (bw), 10% bolus, one-hour infusion, as part of their treatment. Patients will then be observed and followed-up for three months. |
| Primary outcome measure(s) |
1. Symptomatic intracerebral haemorrhage within 24 to 36 hours
2. Death (modified Rankin Scale [mRS] = 6) within three months |
| Secondary outcome measure(s) | Independence for the activities of daily living at three months defined as a modified Rankin score (mRS) of 0 to 2. |
| Sources of funding | The Key Scientific Research Program of the 11th National Five-Year Planning of China (China) |
| Trial website | |
| Publications | |
| Contact name | Prof Yongjun Wang |
| Address |
Beijing Tiantan Hospital
No.6 Tiantan Xili Chongwen District |
| City/town | Beijing |
| Zip/Postcode | 100050 |
| Country | China |
| Tel | +86 (0)10 6709 6699 |
| Fax | +86 (0)10 6701 3383 |
| yongjunwang111@yahoo.com.cn | |
| Sponsor | Beijing Tiantan Hospital (China) |
| Address |
No.6 Tiantan Xili
Chongwen District |
| City/town | Beijing |
| Zip/Postcode | 100050 |
| Country | China |
| Tel | +86 (0)10 6709 6699 |
| Fax | +86 (0)10 6701 3383 |
| yongjunwang111@yahoo.com.cn | |
| Date applied | 03/08/2007 |
| Last edited | 17/08/2007 |
| Date ISRCTN assigned | 17/08/2007 |
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| © 2010 ISRCTN unless otherwise stated. | |
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