Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02064075
Other study ID # 6163-1/2013/EKU
Secondary ID DEOEC RKEB/IKEB:
Status Completed
Phase Phase 4
First received February 9, 2014
Last updated February 13, 2014
Start date February 2013
Est. completion date October 2013

Study information

Verified date February 2014
Source University of Debrecen
Contact n/a
Is FDA regulated No
Health authority Hungary: Scientific and Medical Research Council Ethics Committee
Study type Interventional

Clinical Trial Summary

Purpose:

- Vasospasm and secondary ischemia following subarachnoidal hemorrhage considerably affect the clinical outcome. The purpose of this study is to determine whether crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch) intravenous infusion is more effective in the treatment of subarachnoid hemorrhage (SAH)

Treatment:

- Patients are randomly divided into two groups. Depending on the blood pressure of the patients the members of the first group receive 15-50 ml/kg Lactated-Ringer's solution daily as part of the treatment, while the others 15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution daily.

Measurements:

- Neurological status of patients will be determined by the NIH Stoke Scale Score and the Glasgow Coma Scale (GCS) on a daily basis.

- The mid-term survival and quality of life are evaluated with Barthel Index and Glasgow Outcome Scale (GOS) 14 and 30 days following admission to our clinic.

Hypothesis:

-The prevalence of vasospasms, the mortality rate and the medium-term quality of life following subarachnoid hemorrhage is improved if patients are treated with intravenous colloid (hydroxyethyl starch) infusion compared to intravenous crystalloid infusion.


Description:

Study protocol:

- Upon arrival Computed Tomography Angiography (CTA), or if necessary, a four-vessel cerebral angiography is carried out in case of each patient. Previous medical history is obtained with particular regard to the onset of the symptoms and the premorbid blood pressure values. Afterwards the Hunt-Hess classification of the patients take place. The neurological condition is recorded with the help of the NIH Stroke Scale on a daily basis. An acute or delayed open surgery or endovascular coiling is carried out by either a neurosurgeon or an interventional neuroradiologist as the definitive treatment of the aneurysm.

- Patients are randomized into two groups, either treated with Lactated Ringer's or hydroxyethyl starch solutions. Patients of the Lactated Ringer's are given 15-50 ml/kg/day Lactated Ringer's infusion from the beginning of their enrollment, while members of the other group receive 15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution daily. The blood pressure should not exceed the 160 mmHg systolic and 110 mm Hg mean value prior to the definitive treatment. After definitive care the target blood pressure is set to ensure a clinically optimal state, which should not above 150% of the premorbid blood pressure, and should not exceed 200/120 mmHg. In order to achieve and maintain these values additional vasoactive drugs (arterenol, dobutrex) could be administered regardless of the group in a maximum dose of 2.5 micrograms/kg/min arterenol, with an additional dose of 10 ug/kg/min dobutrex if necessary, if the sole intake of intravenous solutions are not sufficient. Blood pressure is measured invasively, continuously after the cannulation of the radial artery.

- Neurological status of patients will be determined by the NIH Stoke Scale Score and the Glasgow Coma Scale (GCS) on a daily basis. The mid-term survival and quality of life are evaluated with Barthel Index and Glasgow Outcome Scale (GOS) 14 and 30 days following admission to our clinic.

- The primary outcome measure of the study is the incidence rate of vasospasm in both groups, while secondary outcome measures included 30-day survival, the neurological status and GOS scores after.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- patients with subarachnoid hemorrhage

- patients with Hunt-Hess grade I-III.

Exclusion Criteria:

- patients with Hunt-Hess grade IV-V.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Lactated Ringer's solution
15-50 ml/kg Lactated-Ringer's solution was given intravenously every day until discharge.
Hydroxyethyl starch
15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day until discharge.

Locations

Country Name City State
Hungary University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care Debrecen

Sponsors (1)

Lead Sponsor Collaborator
University of Debrecen

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Other Noradrenalin need The overall noradrenalin need during hospital stay. 30 days after the incidence of SAH No
Primary The incidence of vasospasm The presence of vasospasm is assessed with the help of a transcranial doppler device. Vasospasm is diagnosed if the mean blood flow velocity in the middle cerebral artery is higher than 120 cm/s (centimeter/second) The presence of vasospasm is assessed daily between Day 1 and Day 14 in average (plus or minus 5 days) after SAH has occured No
Secondary 30-day survival 30 days after the incidence of SAH No
Secondary Glasgow Outcome Scale 30 days after the incidence of SAH No
Secondary Barthel Index of Activities of Daily Living 30 days after the incidence of SAH No
Secondary National Institutes of Health Stroke Scale 30 days after the incidence of SAH No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Recruiting NCT04189471 - Recovery After Cerebral Hemorrhage
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT05131295 - Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage. Phase 3
Recruiting NCT02962349 - TRansfusion Strategies in Acute Brain INjured Patients N/A
Completed NCT02872857 - Subarachnoid Hemorrhage Recovery And Galantamine Phase 1/Phase 2
Completed NCT03164434 - Influence of Drainage on EVD ICP-signal
Terminated NCT02216513 - Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Phase 0
Completed NCT02389634 - Identification of Novel Molecular Markers for Vasospasm
Not yet recruiting NCT00905931 - Lycopene Following Aneurysmal Subarachnoid Haemorrhage Phase 2
Completed NCT01077206 - High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage Phase 2/Phase 3
Completed NCT01261091 - Early Tracheostomy in Ventilated Stroke Patients N/A
Completed NCT00962546 - Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage N/A
Completed NCT00507104 - Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
Completed NCT00071565 - Familial Intracranial Aneurysm Study II N/A
Recruiting NCT05113381 - The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of IVH N/A
Completed NCT04052646 - Prehospital Deaths From Spontaneous Subarachnoid Haemorrhages
Recruiting NCT04548596 - NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
Recruiting NCT06033378 - Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage. N/A
Completed NCT04308577 - Diet Induced Ketosis for Brain Injury - A Feasibility Study N/A