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NCT Number: NCT05131867

Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy

To evaluate the efficacy and safety of oral Nimodipine and IV milrinone combination therapy for management of cerebral spasm after aneurysmal subarachnoid hemorrhage.

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Key information

Conditions

Oral Nimodipine Milrinone Vascular Spasm After Traumatic Subarachnoidhaemorrhage

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aculty of Medicine,Zagazig University, Zagazig, Sharqia Province, Egypt

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About this study

after being informed about the study and potential risks. All patients giving written consent will be randomized by double-blind manner into 2groups each one containing 15 patients.

Group 1(n =15 ):the patients will receive nimodipine (60 mg/4 hours) orally or via nasogastric tube In group 2(n =15 ): the patients will receive Oral Nimodipine (60 mg/4) will be given orally or in the gastric tube also from the first day of admission, then after the diagnosis of vasospasm is confirmed, start milrinone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients admitted to our surgical ICU
  • aged between (18-60) years old
  • World Federation of Neurological Surgeons grades 1-3 Grades

Exclusion criteria

  • Aneurysmal SAH
  • SAH with Fisher Grade I and IV,
  • World Federation of Neurological Surgeons grade IV & V
  • No informed consent,
  • peripheral vascular disease
  • Cardiac disease (heart block, severe valvular stenosis, cardiomyopathothy , ejection fraction<40%), Renal impairment (serum creatinine ≥ 1.4 mg.L-1), Hemodynamic instability

Treatment and study plan

Nimodipine

Drug

(60 mg/4 hours) orally or via nasogastric tube

Oral Nimodipine and milrinone

Drug

Oral Nimodipine then after the diagnosis of vasospasm is confirmed, start milrinone bolus

Primary outcomes

  1. Concentration of transcutaneous cerebral mixed oxygen saturation

    Time frame: every 24 hours up to 1 week

    by forehead bilateral interconnected adhesive probes

Secondary outcomes

  1. Number of participants having cerebral infarction (cerebral infarction incidence)

    Time frame: every 48 hours up to 1 week

    detected by computed tomography

  2. Number of participants restore of the previous conscious level and motor state(Percentage of drug success)

    Time frame: 1 hour after administration of milrinone and 2 hours after administration of triple H therapy

    restore of the previous conscious level and motor state

  3. value of Glasgow coma scale

    Time frame: every 24 hours up to total days of ICU and hospital stay

    with minimum scale vlue of 3 is the worst and maximum value of 16 indicate better outcome

  4. Number of participants develop one of adverse events

    Time frame: after administration of the study drugs up to 30 days

    hypotension ,bradycardia,hypotesion

  5. Total ICU and hospital stay

    Time frame: up to 30 days after administration of the study drugs

  6. mortality rate

    Time frame: 30 day after administration of the study drugs

    Number of participants died within 30 day after administration of the study drugs

  7. value of Modified Rankin scale

    Time frame: 3,6,12 monthes after drug administration

    Level 0: no symptoms Level 1: no significant disability, despite symptoms; able to perform all usual duties and activities Level 2: slight disability unable to perform all previous activities but able to look after own affairs without assistance Level 3: moderate disability; requires some help, but able to walk without assistance.

    Level 4: moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Level 5: sever disability; bedridden, incontinent and requires nursing care and attention

  8. Glasgow Outcome Scale

    Time frame: 3,6,12 monthes after drug administration

    • Dead: As a direct result of brain trauma, or … due to secondary complications or other complications" "2. Vegetative State: Patients who remain unresponsive and speechless…." "3. Severe Disability: The The patient is conscious but needs the assistance of another person for some activities of daily living every day.…." "4. Moderate Disability: Such a patient is able to look after himself at home, to get out and about to the shops and to travel by public transport. However, some previous activities, either at work or in social life, are now no longer possible by reason of either physical or mental deficit…." "5. Good Recovery: This indicates the capacity to resume normal occupational and social activities, although there may be minor physical or mental deficits…social outcome should be included in the assessment here, such as leisure activities and family relationships..

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy of Oral Nimodipine and Intravenous Milrinone: Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2021
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.