NCT05403970

Brief Summary

In this prospective study, the investigators aim to investigate the effect of the following three factors on the development of vasospasm and patient outcome: (1.) the role of anemia; (2.) the role of plasma fibrinolytic activity; (3.) the role of vitamin D. The investigators include patients admitted to the Neurosurgical Intensive Care Unit of the Clinical Center of the University of Debrecen with the diagnosis of subarachnoid hemorrhage (SAH). Patients are treated according to international guidelines. As part of the study protocol the following investigations are performed: • Hemoglobin level measurement: on the day of admission and day 3-4-7 and 14 after hemorrhage •Modified clot lysis assay (mCLA): on the day of admission and day 7 after hemorrhage •25-hydroxy vitamin-D level measurement: on the day of admission •Transcranial color-coded duplex sonography (detecting vasospasm): on daily basis. •30 day follow-up: mortality, Glasgow Outcome Scale (GOS), Karnofsky score, Barthel score •90 day follow-up: mortality, Glasgow Outcome Scale , Karnofsky score, Barthel score. Laboratory test results are correlated with (a) the development of vasospasm; (b) with 30 and 90 day outcome. Perspectives of the planned study: Considering the currently available therapeutic range for patients with SAH, results of the present study may provide a basis for designing further randomized, prospective trials to investigate the effect of treating anemia, anticoagulation and vitamin-D supplementation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

2.6 years

First QC Date

May 31, 2022

Last Update Submit

June 27, 2022

Conditions

Subarachnoid Hemorrhage

Keywords

subarachnoid hemorrhageanemiavasospasmvitamin Dmodified clot lysis assay

Outcome Measures

Primary Outcomes (3)

  • Hemoglobin level

    correlation with the development of vasospasm

    day of admission, day 3-4-7 and 14 after hemorrhage

  • mCLA

    correlation with the development of vasospasm

    day of admission, day 7 after hemorrhage

  • 25-hydroxy vitamin-D level

    correlation with the development of vasospasm

    day of admission

Secondary Outcomes (3)

  • Hemoglobin level

    day 14, 30 and 90 after hemorrhage

  • mCLA

    day 14, 30 and 90 after hemorrhage

  • 25-hydroxy vitamin-D level

    day 14, 30 and 90 after hemorrhage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study intends to include all patients over 18 years of age who were admitted to our clinic within 48 hours after the bleeding regardless of gender, neurological status or age.

You may qualify if:

  • acut SAH
  • patients older than 18 years
  • admission within 48 hours after symptom onset

You may not qualify if:

  • admission over 48 hours after symptom onset
  • traumatic SAH
  • Angioma
  • A-V malformation
  • Patient unable to consent and no relative available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Szántó Dorottya

Debrecen, Hajdú-Bihar, 4032, Hungary

RECRUITING

Related Publications (13)

  • Etminan N, Chang HS, Hackenberg K, de Rooij NK, Vergouwen MDI, Rinkel GJE, Algra A. Worldwide Incidence of Aneurysmal Subarachnoid Hemorrhage According to Region, Time Period, Blood Pressure, and Smoking Prevalence in the Population: A Systematic Review and Meta-analysis. JAMA Neurol. 2019 May 1;76(5):588-597. doi: 10.1001/jamaneurol.2019.0006.

    PMID: 30659573BACKGROUND

  • Epidemiology of aneurysmal subarachnoid hemorrhage in Australia and New Zealand: incidence and case fatality from the Australasian Cooperative Research on Subarachnoid Hemorrhage Study (ACROSS). Stroke. 2000 Aug;31(8):1843-50. doi: 10.1161/01.str.31.8.1843.

    PMID: 10926945BACKGROUND

  • Ingall T, Asplund K, Mahonen M, Bonita R. A multinational comparison of subarachnoid hemorrhage epidemiology in the WHO MONICA stroke study. Stroke. 2000 May;31(5):1054-61. doi: 10.1161/01.str.31.5.1054.

    PMID: 10797165BACKGROUND

  • Rowland MJ, Hadjipavlou G, Kelly M, Westbrook J, Pattinson KT. Delayed cerebral ischaemia after subarachnoid haemorrhage: looking beyond vasospasm. Br J Anaesth. 2012 Sep;109(3):315-29. doi: 10.1093/bja/aes264.

    PMID: 22879655BACKGROUND

  • Claassen J, Vu A, Kreiter KT, Kowalski RG, Du EY, Ostapkovich N, Fitzsimmons BF, Connolly ES, Mayer SA. Effect of acute physiologic derangements on outcome after subarachnoid hemorrhage. Crit Care Med. 2004 Mar;32(3):832-8. doi: 10.1097/01.ccm.0000114830.48833.8a.

    PMID: 15090970BACKGROUND

  • Dorsch NW, King MT. A review of cerebral vasospasm in aneurysmal subarachnoid haemorrhage Part I: Incidence and effects. J Clin Neurosci. 1994 Jan;1(1):19-26. doi: 10.1016/0967-5868(94)90005-1.

    PMID: 18638721BACKGROUND

  • Chamling B, Gross S, Stoffel-Wagner B, Schubert GA, Clusmann H, Coburn M, Hollig A. Early Diagnosis of Delayed Cerebral Ischemia: Possible Relevance for Inflammatory Biomarkers in Routine Clinical Practice? World Neurosurg. 2017 Aug;104:152-157. doi: 10.1016/j.wneu.2017.05.021. Epub 2017 May 13.

    PMID: 28512045BACKGROUND

  • McBride DW, Blackburn SL, Peeyush KT, Matsumura K, Zhang JH. The Role of Thromboinflammation in Delayed Cerebral Ischemia after Subarachnoid Hemorrhage. Front Neurol. 2017 Oct 23;8:555. doi: 10.3389/fneur.2017.00555. eCollection 2017.

    PMID: 29109695BACKGROUND

  • Sampson TR, Dhar R, Diringer MN. Factors associated with the development of anemia after subarachnoid hemorrhage. Neurocrit Care. 2010 Feb;12(1):4-9. doi: 10.1007/s12028-009-9273-1. Epub 2009 Sep 24.

    PMID: 19777386BACKGROUND

  • Orban-Kalmandi R, Arokszallasi T, Fekete I, Fekete K, Heja M, Toth J, Sarkady F, Csiba L, Bagoly Z. A Modified in vitro Clot Lysis Assay Predicts Outcomes in Non-traumatic Intracerebral Hemorrhage Stroke Patients-The IRONHEART Study. Front Neurol. 2021 Apr 20;12:613441. doi: 10.3389/fneur.2021.613441. eCollection 2021.

    PMID: 33959087BACKGROUND

  • Kashefiolasl S, Leisegang MS, Helfinger V, Schurmann C, Pfluger-Muller B, Randriamboavonjy V, Vasconez AE, Carmeliet G, Badenhoop K, Hintereder G, Seifert V, Schroder K, Konczalla J, Brandes RP. Vitamin D-A New Perspective in Treatment of Cerebral Vasospasm. Neurosurgery. 2021 Feb 16;88(3):674-685. doi: 10.1093/neuros/nyaa484.

    PMID: 33269399BACKGROUND

  • Diringer MN, Bleck TP, Claude Hemphill J 3rd, Menon D, Shutter L, Vespa P, Bruder N, Connolly ES Jr, Citerio G, Gress D, Hanggi D, Hoh BL, Lanzino G, Le Roux P, Rabinstein A, Schmutzhard E, Stocchetti N, Suarez JI, Treggiari M, Tseng MY, Vergouwen MD, Wolf S, Zipfel G; Neurocritical Care Society. Critical care management of patients following aneurysmal subarachnoid hemorrhage: recommendations from the Neurocritical Care Society's Multidisciplinary Consensus Conference. Neurocrit Care. 2011 Sep;15(2):211-40. doi: 10.1007/s12028-011-9605-9.

    PMID: 21773873BACKGROUND

  • Maher M, Schweizer TA, Macdonald RL. Treatment of Spontaneous Subarachnoid Hemorrhage: Guidelines and Gaps. Stroke. 2020 Apr;51(4):1326-1332. doi: 10.1161/STROKEAHA.119.025997. Epub 2020 Jan 22. No abstract available.

    PMID: 31964292BACKGROUND

MeSH Terms

Conditions

Subarachnoid HemorrhageAnemia

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Csilla Molnár, MD Associate professor

    Department of Anesthesiology and Intensive Care, University of Debrecen, Health and Medical Science Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorottya Szántó, MD

CONTACT

+36 30 9990718dorottyaszanto22@gmail.com

Erzsébet Igbonu-Nagy, study nurse

CONTACT

+36 20 399 1551nagyboske@med.unideb.hu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 3, 2022

Study Start

June 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 1, 2022

Record last verified: 2022-06

Locations

HU(1)