Proper Timing of Control of Hypertension and Outcome in Acute Spontaneous Intracerebral Hemorrhage.

NCT04167644 | Completed

• 1 other identifier: Mansoura University Hospital 7
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The ideal management of blood pressure in BP after acute intracerebral haemorrhage is still debated and whether a higher intensive reduction of blood pressure after acute intracerebral haemorrhage may be better or not is still controversial. Conflicting results from different randomized trials in regards to the clinical guidelines for management of hypertension in people with acute intracerebral hemorrhage (ICH). These results indicate that the management of BP and the prognosis after acute spontaneous ICH are very complicated. Therefore, analysis based on actual blood pressure (BP) accomplished may be a more efficient method to assess the impact of BP management on outcome of ICH. In our research, blood pressure (BP) management and prognosis were studied in patients with acute intracerebral hemorrhage to decide the perfect time control BP to improve outcome.

Conditions

Intra Cerebral Hemorrhage; Hypertension

Keywords

ICH, Hypertension, GCS , and mRS.

Outcome Measures

Primary Outcomes (2)

• Glasgow Coma Scale score

  Initial Glasgow Coma Scale score at admission to hospital and patients according to GCS score were classified to 3 groups I (13-15), II (5-12), and III (3-4 ) according to Hemphill et al 2001.

  24 hours

• CT brain

  CT brain was accomplished for all patients at onset of admission to hospital to decide the characters of spontaneous intracerebral hemorrhage (ICH). The volume of the intracerebral hemorrhage was determined utilizing the ABC/2 method (A is the most great diameter on the most large ICH cut, B is the diameter perpendicular to A, while, C is the number of axial cuts of ICH multiplied by the thickness of cuts. Additionally, the location ICH (regardless of whether infra or supatrentorial), and if there is IVH or not, also, if there is shift of midline structure or hydrocephalic changes were determined. Regarding ICH volume, patients were partitioned into two groups (\< 30 cm3 and ≥30 cm3)

  24 hours

Secondary Outcomes (1)

• Modified Rankin Scale (mRS)

  24 hours

Study Arms (2)

Unfavorable outcome

80 patients with poor outcome were classified according to mRS score after discharge (mRS range from 3 up to 6).

Diagnostic Test: Modified Rankin Scale (mRS)

Favorable outcome

70 patients with better outcome were classified according to mRS score after discharge (mRS range from 0 up to 2) .

Diagnostic Test: Modified Rankin Scale (mRS)

Interventions

Modified Rankin Scale (mRS) DIAGNOSTIC_TEST

Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. We characterized a favorable outcome as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to six

Favorable outcome; Unfavorable outcome

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The present study was conducted during the period from May 2018 to the end of April 2019. This study was conducted on150 patients presented by acute spontaneous intracerebral hemorrhage (ICH) were admitted to the Department of Neurology of Mansoura University Hospital. Modified Rankin Scale score (mRS) after discharge was calculated and accordingly, patients were partitioned into two main groups: The first group was favorable outcome patients (mRS queal 0-2) and the second group was unfavorable outcome patients (mRS queal 3-6). Independent factors that were significantly related to prognosis were assessed by multivariate logistic regression.

You may qualify if:

• \- Patients incorporated into this study aged over 25 years of either sex with first spontaneous intracerebral hemorrhage (ICH).

You may not qualify if:

• Secondary ICH were excluded from this study (like traumatic, hemorrhagic infarcts, AVM, bleeding tumors or SOL, or IVH only without ICH).
• Patients with previous ischemic stroke or T1As

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Egypt

Location

Related Publications (18)

• Al-Mufti F, Thabet AM, Singh T, El-Ghanem M, Amuluru K, Gandhi CD. Clinical and Radiographic Predictors of Intracerebral Hemorrhage Outcome. Interv Neurol. 2018 Feb;7(1-2):118-136. doi: 10.1159/000484571. Epub 2018 Jan 12.

  PMID: 29628951 BACKGROUND

• Lattanzi S, Silvestrini M. Blood pressure in acute intra-cerebral hemorrhage. Ann Transl Med. 2016 Aug;4(16):320. doi: 10.21037/atm.2016.08.04. No abstract available.

  PMID: 27668240 BACKGROUND

• Sakamoto Y, Koga M, Toyoda K. Response to letter regarding article, "Systolic blood pressure after intravenous antihypertensive treatment and clinical outcomes in hyperacute intracerebral hemorrhage: the stroke acute management with urgent risk-factor assessment and improvement-intracerebral hemorrhage study". Stroke. 2013 Nov;44(11):e153. doi: 10.1161/STROKEAHA.113.002903. Epub 2013 Sep 17. No abstract available.

  PMID: 24046009 BACKGROUND

• Rabinstein AA. Optimal Blood Pressure After Intracerebral Hemorrhage: Still a Moving Target. Stroke. 2018 Feb;49(2):275-276. doi: 10.1161/STROKEAHA.117.020058. Epub 2018 Jan 4. No abstract available.

  PMID: 29301975 BACKGROUND

• Wang X, Arima H, Heeley E, Delcourt C, Huang Y, Wang J, Stapf C, Robinson T, Woodward M, Chalmers J, Anderson CS; INTERACT2 Investigators. Magnitude of blood pressure reduction and clinical outcomes in acute intracerebral hemorrhage: intensive blood pressure reduction in acute cerebral hemorrhage trial study. Hypertension. 2015 May;65(5):1026-32. doi: 10.1161/HYPERTENSIONAHA.114.05044. Epub 2015 Mar 23.

  PMID: 25801872 BACKGROUND

• Wang X, Arima H, Al-Shahi Salman R, Woodward M, Heeley E, Stapf C, Lavados PM, Robinson T, Huang Y, Wang J, Delcourt C, Anderson CS. Rapid Blood Pressure Lowering According to Recovery at Different Time Intervals after Acute Intracerebral Hemorrhage: Pooled Analysis of the INTERACT Studies. Cerebrovasc Dis. 2015;39(3-4):242-8. doi: 10.1159/000381107. Epub 2015 Mar 25.

  PMID: 25823544 BACKGROUND

• Anderson CS, Heeley E, Huang Y, Wang J, Stapf C, Delcourt C, Lindley R, Robinson T, Lavados P, Neal B, Hata J, Arima H, Parsons M, Li Y, Wang J, Heritier S, Li Q, Woodward M, Simes RJ, Davis SM, Chalmers J; INTERACT2 Investigators. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013 Jun 20;368(25):2355-65. doi: 10.1056/NEJMoa1214609. Epub 2013 May 29.

  PMID: 23713578 BACKGROUND

• Qureshi AI, Palesch YY, Barsan WG, Hanley DF, Hsu CY, Martin RL, Moy CS, Silbergleit R, Steiner T, Suarez JI, Toyoda K, Wang Y, Yamamoto H, Yoon BW; ATACH-2 Trial Investigators and the Neurological Emergency Treatment Trials Network. Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage. N Engl J Med. 2016 Sep 15;375(11):1033-43. doi: 10.1056/NEJMoa1603460. Epub 2016 Jun 8.

  PMID: 27276234 BACKGROUND

• Lattanzi S, Silvestrini M. Optimal achieved blood pressure in acute intracerebral hemorrhage: INTERACT2. Neurology. 2015 Aug 11;85(6):557-8. doi: 10.1212/01.wnl.0000470918.40985.d0. No abstract available.

  PMID: 26259858 BACKGROUND

• Moullaali TJ, Wang X, Woodhouse LJ, Law ZK, Delcourt C, Sprigg N, Krishnan K, Robinson TG, Wardlaw JM, Al-Shahi Salman R, Berge E, Sandset EC, Anderson CS, Bath PM; BASC Investigators. Lowering blood pressure after acute intracerebral haemorrhage: protocol for a systematic review and meta-analysis using individual patient data from randomised controlled trials participating in the Blood Pressure in Acute Stroke Collaboration (BASC). BMJ Open. 2019 Jul 16;9(7):e030121. doi: 10.1136/bmjopen-2019-030121.

  PMID: 31315876 BACKGROUND

• Qureshi AI, Palesch YY, Foster LD, Barsan WG, Goldstein JN, Hanley DF, Hsu CY, Moy CS, Qureshi MH, Silbergleit R, Suarez JI, Toyoda K, Yamamoto H; ATACH 2 Trial Investigators. Blood Pressure-Attained Analysis of ATACH 2 Trial. Stroke. 2018 Jun;49(6):1412-1418. doi: 10.1161/STROKEAHA.117.019845. Epub 2018 May 22.

  PMID: 29789395 BACKGROUND

• Hemphill JC 3rd, Bonovich DC, Besmertis L, Manley GT, Johnston SC. The ICH score: a simple, reliable grading scale for intracerebral hemorrhage. Stroke. 2001 Apr;32(4):891-7. doi: 10.1161/01.str.32.4.891.

  PMID: 11283388 BACKGROUND

• Banks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007 Mar;38(3):1091-6. doi: 10.1161/01.STR.0000258355.23810.c6. Epub 2007 Feb 1.

  PMID: 17272767 BACKGROUND

• Maeda AK, Aguiar LR, Martins C, Bichinho GL, Gariba MA. Hematoma volumes of spontaneous intracerebral hemorrhage: the ellipse (ABC/2) method yielded volumes smaller than those measured using the planimetric method. Arq Neuropsiquiatr. 2013 Aug;71(8):540-4. doi: 10.1590/0004-282X20130084.

  PMID: 23982013 BACKGROUND

• Hu TT, Yan L, Yan PF, Wang X, Yue GF. Assessment of the ABC/2 Method of Epidural Hematoma Volume Measurement as Compared to Computer-Assisted Planimetric Analysis. Biol Res Nurs. 2016 Jan;18(1):5-11. doi: 10.1177/1099800415577634. Epub 2015 Mar 23.

  PMID: 25802386 BACKGROUND

• Shi J, Cai Z, Han W, Dong B, Mao Y, Cao J, Wang S, Guan W. Stereotactic Catheter Drainage Versus Conventional Craniotomy for Severe Spontaneous Intracerebral Hemorrhage in the Basal Ganglia. Cell Transplant. 2019 Aug;28(8):1025-1032. doi: 10.1177/0963689719852302. Epub 2019 May 27.

  PMID: 31129993 BACKGROUND

• Ahmed Esmael, Mohammed El Sherif and Mohamed Saad. Prediction of 30-days Mortality of Intracerebral Hemorrhage by a Powerful but Easy to Use Intracerebral Hemorrhage Score. 2016; 6 (2): 1-11.

  BACKGROUND

• Cordonnier C, Demchuk A, Ziai W, Anderson CS. Intracerebral haemorrhage: current approaches to acute management. Lancet. 2018 Oct 6;392(10154):1257-1268. doi: 10.1016/S0140-6736(18)31878-6.

  PMID: 30319113 RESULT

MeSH Terms

Conditions

Cerebral Hemorrhage; Hypertension; Hepatitis, Infectious Canine

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis, Viral, Animal; Hepatitis, Animal; Infections; Adenoviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis; Liver Diseases; Digestive System Diseases; Dog Diseases; Animal Diseases

Study Officials

• Esmael M Ahmed, MD

  Assistant Prof of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof of Neurology

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 19, 2019
• Study Start: May 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)