Trials Sponsors Conditions Drugs Pricing

Conditions

Aneurysmal Subarachnoid Hemorrhage Neurobehavioral Manifestations Vasospasm, Intracranial Intracranial Aneurysm Heparin-induced Thrombocytopenia Type II

Keywords

aneurysmal subarachnoid hemorrhageunfractionated heparinneurobehavioral manifestationsdelayed ischemic neurological deficitscerebral aneurysmcoil embolizationMontreal Cognitive Assessment

Outcome Measures

Primary Outcomes (2)

Montreal Cognitive Assessment (MoCA)
Primary Clinical Outcome Measure- mean score compared between groups
90-day follow-up visit
Rate of "Major Bleeding" or "Clinically Relevant Non-Major Bleeding"
As defined by the International Society of Thrombosis and Heamostasis (ISTH) Primary Safety Outcome Measure-
Patients will be followed for the duration of the hospital stay; an expected average of 3 weeks

Secondary Outcomes (25)

Rate of "Major Bleeding"
Participants will be followed for the duration of the hospital stay, an expected average of 3 weeks

Study Arms (2)

Control

NO INTERVENTION

Standard of Care

LDIVH (Unfractionated Heparin)

EXPERIMENTAL

Continuous Low-Dose IV Unfractionated Heparin Infusion

Drug: Continuous Low-Dose IV Unfractionated Heparin Infusion

Interventions

Continuous Low-Dose IV Unfractionated Heparin InfusionDrug

Continuous intravenous infusion of a low-dose unfractionated heparin drip

Also known as: Heparin, Unfractionated Heparin, Heparin drip, IV Heparin

LDIVH (Unfractionated Heparin)

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 and ≤ 70 years
Historical modified Rankin Scale Score 0-1

Sponsors & Collaborators

Indiana University
Othercollaborator
Robert F. James
Otherlead

Study Sites (9)

Yale University

New Haven, Connecticut, United States

University of Florida

Gainesville, Florida, United States

Tallahassee Neurological Clinic

Tallahassee, Florida, United States

Rush University

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, 46202, United States

University of Louisville

Louisville, Kentucky, 40202, United States

University of Michigan

Ann Arbor, Michigan, United States

Related Publications (10)

Simard JM, Schreibman D, Aldrich EF, Stallmeyer B, Le B, James RF, Beaty N. Unfractionated heparin: multitargeted therapy for delayed neurological deficits induced by subarachnoid hemorrhage. Neurocrit Care. 2010 Dec;13(3):439-49. doi: 10.1007/s12028-010-9435-1.
PMID: 20809188BACKGROUND
Al-Khindi T, Macdonald RL, Schweizer TA. Cognitive and functional outcome after aneurysmal subarachnoid hemorrhage. Stroke. 2010 Aug;41(8):e519-36. doi: 10.1161/STROKEAHA.110.581975. Epub 2010 Jul 1.
PMID: 20595669BACKGROUND

MeSH Terms

Conditions

Subarachnoid HemorrhageNeurobehavioral ManifestationsVasospasm, IntracranialIntracranial Aneurysm

Interventions

Heparin

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic Processes

Study Officials

Robert F James, MD
Indiana University
PRINCIPAL INVESTIGATOR
J Marc Simard, MD, PhD
University of Maryland
PRINCIPAL INVESTIGATOR
J Mocco, MD, MSc
Icahn School of Medicine at Mount Sinai
PRINCIPAL INVESTIGATOR
Kevin N Sheth, MD
Yale University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Professor of Neurosurgery

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 17, 2015

Study Start

April 2016

Actual (reported)

Primary Completion

January 2023

Estimated (date passed)

You may not qualify if:

Angio-negative SAH.
History or imaging suggesting that the current hemorrhage presentation is a recent re-rupture of the aneurysm. Prior sentinel headache with negative CT or prior sentinel headache where the patient did not seek medical attention does not exclude the patient.
Surgical Clipping (or plan for clipping) of the ruptured aneurysm or any non- ruptured aneurysm on the same admission.
Aneurysm is identified to be traumatic, mycotic, blister or fusiform type by catheter DSA.
Any intracranial stent placement or non-coil intra-aneurysmal device where dual- antiplatelet therapy is needed during admission.
Patient received heparin in any form within the last 100 days prior to current presentation / admission.
Thrombocytopenia (platelet count less than 100,000 - assuming clumping has been ruled out as a cause).
Patient has a documented history of heparin induced thrombocytopenia (HIT).
Patient developed SAH-induced cardiac stunning prior to enrollment, with an ejection fraction \<30%, or requiring IV medications for blood pressure maintenance.
Concurrent significant intracranial pathology identified prior to enrollment, including but not limited to, Moyamoya disease, high suspicion or documented CNS vasculitis, severe fibromuscular dysplasia, arteriovenous malformation, arteriovenous fistula, or malignant brain tumor.
Thrombolytic therapy within 24 hours prior to enrollment (rtPA, urokinase, etc.)
Plan for antiplatelet or oral anticoagulation therapy from the time of the coil embolization procedure until 14 full days after enrollment. Antiplatelet therapy may be resumed after the 14-day window. A single 325 mg Aspirin (or lower dose) given during the coil embolization peri-procedural period is acceptable if this is the local standard of care but should be documented.
Concomitant serious or uncontrolled disease such as severe infection, active (non- remission) cancer, severe organ dysfunction (severe heart failure, severe chronic kidney impairment requiring dialysis or severe chronic liver disease) or any coagulopathy (including DIC or bleeding diathesis).
Uncontrollable hypertension (\>180 systolic and/or \>110 diastolic) that is not correctable prior to enrollment.
Active Immunosuppression therapy including chronic corticosteroid usage.
+4 more criteria

Aneurysmal Subarachnoid Hemorrhage Trial RandOmizing Heparin

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (25)

Study Arms (2)

Control

LDIVH (Unfractionated Heparin)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Other Outcomes (1)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (25)

Study Arms (2)

Control

LDIVH (Unfractionated Heparin)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Other Outcomes (1)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations