|- candidate number||22508|
|- NTR Number||NTR5332|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-jul-2015|
|- Secondary IDs||W14_243 # 14.17.0295 |
|- Public Title||Thrombolysis and Uncontrolled Hypertension|
|- Scientific Title||Thrombolysis and Uncontrolled Hypertension|
|- hypothesis||We hypothesize that the active strategy leads to a better functional outcome than the conservative strategy three months after acute ischemic stroke, in patients with elevated pre-treatmen blood pressure otherwise eligible for intravenous thrombolysis.
Secondary hypotheses are that this effect occurs despite increasing the number of sICHs, and could be attributable to a higher rate of IVT treatments and a shorter door-to-needle time.
|- Healt Condition(s) or Problem(s) studied||Ischemic stroke, Blood pressure, Throbectmy|
|- Inclusion criteria||- Age 18 years or above.|
- Intravenous thrombolysis indicated.
- Intravenous thrombolysis postponed or withheld because of blood pressure above 185/110 mmHg.
- No contraindications for IVT other than high blood pressure.
|- Exclusion criteria||None|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jan-2015|
|- planned closingdate||1-jan-2019|
|- Target number of participants||1235|
|- Interventions||Patients admitted to centers with an active strategy will be compared to those admitted to centers with a conservative strategy.|
|- Primary outcome||Functional outcome (modified Rankin Scale) at three months.|
|- Secondary outcome||Symptomatic intracranial hemorrhage|
Intravenous thrombolysis rate
|- Trial web site||http://www.strokeamc.nl/truth|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| |
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Intravenous thrombolysis (IVT) with recombinant tissue plasminogen activator is an effective treatment in acute ischemic stroke. However, IVT is contraindicated when blood pressure (BP) is above 185/110 mm Hg, because of an increased risk on symptomatic intracranial hemorrhage (sICH). In Dutch clinical practice, two distinct strategies are used in this situation.
The active strategy comprises lowering BP with antihypertensive agents below these thresholds to allow start of IVT. In the conservative strategy, IVT is administered only when BP drops spontaneously below protocolled thresholds.
We hypothesize that the active strategy leads to a better functional outcome three months after acute ischemic stroke. Secondary hypotheses are that this effect occurs despite increasing the number of sICHs, and could be attributable to a higher rate of IVT treatments and a shorter door-to-needle time.
The TRUTH is a prospective, observational, cluster-based, parallel group follow-up study; in which participating centers continue their current local treatment guidelines. Outcomes of patients admitted to centers with an active will be compared to those admitted to centers with a conservative strategy.
The TRUTH is the first large prospective study specifically studying IVT-candidates with elevated BP, and has the potential to change clinical practice and optimize acute stroke care in these patients.
|- Main changes (audit trail)|
|- RECORD||28-jul-2015 - 24-aug-2015|