NCT03093233

Brief Summary

Intracerebral hemorrhage \[ICH\] is the most feared complication of oral anticoagulation \[OAC\], yet therapeutic strategies are limited reflected by overall weak guideline recommendations. Studies investigating acute interventions especially in patients with ICH taking non-vitamin-K-oral-anticoagulants \[NOAC\] remain inconclusive. Further, acute management issues in OAC-ICH patients (hematoma evacuation surgery, prevention of acute thromboembolic events, intraventricular fibrinolysis) still need to be investigated. Therefore, this observational study (RETRACE-II) represents the follow-up investigation to RETRACE (German-wide Multicenter Analysis of Oral Anticoagulant-associated Intracerebral Hemorrhage, study-period 2006-2010, NCT01829581), now spanning a study-period from 2011 until 2015 with 19 participating tertiary care centers nation-wide in Germany. Data pooling of the two RETRACE studies, altogether including more than 2500 patients treated at 22 centers over a 10 year period will allow statistically appropriate analyses of different outcomes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,369

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
Last Updated

May 16, 2024

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

March 3, 2017

Last Update Submit

May 13, 2024

Conditions

Anticoagulation Associated (VKA & NOAC) Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (5)

  • Hematoma enlargement (NOAC- versus VKA-ICH)

    24hour

  • Intracranial complications (ischemic and hemorrhagic events)

    through study period (hospital stay), an average of 14day

  • Extracranial complications (ischemic and hemorrhagic events)

    through study period (hospital stay), an average of 14day

  • Mortality

    at 90 days

  • Functional outcome (modified Rankin-Scale 4-6)

    at 90 days

Secondary Outcomes (4)

  • Systolic blood pressure level in NOAC-ICH

    24hour

  • Functional outcome (modified Rankin-Scale 4-6) after hematoma evacuation surgery

    at 90 days

  • Functional outcome (modified Rankin-Scale 4-6) according to anticoagulation treatment

    at 90 days

  • Functional outcome (modified Rankin-Scale 4-6) after intraventricular fibrinolysis

    at 90 days

Study Arms (1)

VKA- and NOAC-related ICH

1. Analysis of hematoma enlargement: prevalence, risk factor, associations with therapeutic interventions (in patients with cranial follow-up imaging) 2. Association of hematoma evacuation surgery with clinical outcomes 3. Associations of antithrombotic management with ischemic and hemorrhagic complications 4. Safety of intraventricular fibrinolysis (in patients with severe intraventricular hemorrhage)

Other: no intervention

Interventions

no interventionOTHER

only descriptive data analysis

VKA- and NOAC-related ICH

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Anticoagulation (VKA \& NOAC) associated ICH

You may qualify if:

  • VKA-ICH defined as effective use of VKA with an INR-value of \>1.5 on hospital admission
  • NOAC-ICH defined as known to be on treatment with NOAC at ICH-onset

You may not qualify if:

  • ICH related to trauma, tumor, arteriovenous malformation, aneurysmal subarachnoid hemorrhage, acute thrombolysis, or other coagulopathies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Kuramatsu JB, Gerner ST, Schellinger PD, Glahn J, Endres M, Sobesky J, Flechsenhar J, Neugebauer H, Juttler E, Grau A, Palm F, Rother J, Michels P, Hamann GF, Huwel J, Hagemann G, Barber B, Terborg C, Trostdorf F, Bazner H, Roth A, Wohrle J, Keller M, Schwarz M, Reimann G, Volkmann J, Mullges W, Kraft P, Classen J, Hobohm C, Horn M, Milewski A, Reichmann H, Schneider H, Schimmel E, Fink GR, Dohmen C, Stetefeld H, Witte O, Gunther A, Neumann-Haefelin T, Racs AE, Nueckel M, Erbguth F, Kloska SP, Dorfler A, Kohrmann M, Schwab S, Huttner HB. Anticoagulant reversal, blood pressure levels, and anticoagulant resumption in patients with anticoagulation-related intracerebral hemorrhage. JAMA. 2015 Feb 24;313(8):824-36. doi: 10.1001/jama.2015.0846.

    PMID: 25710659BACKGROUND

  • Huttner HB, Gerner ST, Kuramatsu JB, Connolly SJ, Beyer-Westendorf J, Demchuk AM, Middeldorp S, Zotova E, Altevers J, Andersohn F, Christoph MJ, Yue P, Stross L, Schwab S. Hematoma Expansion and Clinical Outcomes in Patients With Factor-Xa Inhibitor-Related Atraumatic Intracerebral Hemorrhage Treated Within the ANNEXA-4 Trial Versus Real-World Usual Care. Stroke. 2022 Feb;53(2):532-543. doi: 10.1161/STROKEAHA.121.034572. Epub 2021 Oct 14.

    PMID: 34645283DERIVED

  • Gerner ST, Kuramatsu JB, Sembill JA, Sprugel MI, Hagen M, Knappe RU, Endres M, Haeusler KG, Sobesky J, Schurig J, Zweynert S, Bauer M, Vajkoczy P, Ringleb PA, Purrucker JC, Rizos T, Volkmann J, Mullges W, Kraft P, Schubert AL, Erbguth F, Nueckel M, Schellinger PD, Glahn J, Knappe UJ, Fink GR, Dohmen C, Stetefeld H, Fisse AL, Minnerup J, Hagemann G, Rakers F, Reichmann H, Schneider H, Rahmig J, Ludolph AC, Stosser S, Neugebauer H, Rother J, Michels P, Schwarz M, Reimann G, Bazner H, Schwert H, Classen J, Michalski D, Grau A, Palm F, Urbanek C, Wohrle JC, Alshammari F, Horn M, Bahner D, Witte OW, Gunther A, Hamann GF, Engelhorn T, Lucking H, Dorfler A, Schwab S, Huttner HB. Characteristics in Non-Vitamin K Antagonist Oral Anticoagulant-Related Intracerebral Hemorrhage. Stroke. 2019 Jun;50(6):1392-1402. doi: 10.1161/STROKEAHA.118.023492. Epub 2019 May 16.

    PMID: 31092170DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hagen B. Huttner, MD.

    University Hospital Erlangen, Department of Neurology, Germany

    PRINCIPAL INVESTIGATOR

  • Joji B. Kuramatsu, MD.

    University Hospital Erlangen, Department of Neurology, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 28, 2017

Study Start

January 1, 2016

Primary Completion

April 4, 2016

Study Completion

August 30, 2016

Last Updated

May 16, 2024

Record last verified: 2017-03