Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept

NCT ID: NCT00961532

Last Updated: 2014-08-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-12-31

Brief Summary

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The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start.

Detailed Description

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Conditions

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Intracerebral Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DDAVP

DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes

Group Type EXPERIMENTAL

DDAVP injection (desmopressin acetate)

Intervention Type DRUG

0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes

Interventions

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DDAVP injection (desmopressin acetate)

0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Spontaneous intracerebral hemorrhage as documented by head CT scan
* Documented regular aspirin use or VerifyNow-ASA result of ≤ 550 aspirin reaction units (ARU), indicating anti-platelet medication

Exclusion Criteria

* International normalized ratio (INR) of ≥ 1.7 from coagulopathy or warfarin use
* History of von Willebrand disease
* Pregnancy
* Known hypersensitivity to DDAVP or desmopressin
* Active cardiovascular disease or unstable angina
* Hyponatremia or history of hyponatremia
* Current or historical deep venous thrombosis or pulmonary embolism
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern Memorial Hospital

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Andrew Naidech

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew M Naidech, MD MSPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Naidech AM, Maas MB, Levasseur-Franklin KE, Liotta EM, Guth JC, Berman M, Rosenow JM, Lindholm PF, Bendok BR, Prabhakaran S, Bernstein RA, Kwaan HC. Desmopressin improves platelet activity in acute intracerebral hemorrhage. Stroke. 2014 Aug;45(8):2451-3. doi: 10.1161/STROKEAHA.114.006061. Epub 2014 Jul 8.

Reference Type RESULT
PMID: 25005444 (View on PubMed)

Other Identifiers

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STU8168

Identifier Type: -

Identifier Source: org_study_id

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