Desmopressin for Bleeding Related to Low Body Temperature

NCT ID: NCT00902057

Last Updated: 2009-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

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To study, with a prospective randomised controlled design, whether the subcutaneous administration of the haemostatic drug desmopressin, may improve the impairment of primary haemostasis due to mildly decreased temperature.

Detailed Description

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Conditions

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Hypothermia Induced Impairment of Primary Haemostasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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desmopressin 3

Group Type ACTIVE_COMPARATOR

desmopressin

Intervention Type DRUG

single desmopressin subcutaneous injection, 3mcg

desmopressin 15

Group Type ACTIVE_COMPARATOR

desmopressin

Intervention Type DRUG

single desmopressin subcutaneous injection, 15mcg

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

saline subcutaneous

desmopressin 1.5

Group Type ACTIVE_COMPARATOR

desmopressin

Intervention Type DRUG

single desmopressin subcutaneous injection, 1.5mcg

Interventions

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desmopressin

single desmopressin subcutaneous injection, 1.5mcg

Intervention Type DRUG

desmopressin

single desmopressin subcutaneous injection, 3mcg

Intervention Type DRUG

desmopressin

single desmopressin subcutaneous injection, 15mcg

Intervention Type DRUG

placebo

saline subcutaneous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy volunteers

Exclusion Criteria

1. Any known platelet or coagulation disorder.
2. Pregnant or lactating women.
3. Known chronic liver or renal disease.
4. Coronary artery, carotid artery or peripheral artery disease
5. Recent history of taking antiplatelet drugs, anticoagulants or herbal preparations.
6. Smoker or alcohol user
7. Mentally incapable of providing informed consent
8. Students or junior staff members who had direct working relationship with the PI
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Department of Anaesthesiology, the Univeristy of Hong Kong

Locations

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The University of Hong Kong

Hong Kong, Hong Kong, China

Site Status

Countries

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China

Central Contacts

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Kwok F.J. Ng, MBChB, MD, MBA, FANZCA, FHKAM

Role: CONTACT

(852) 28553303

Facility Contacts

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Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM, MBA

Role: primary

(852) 28553303

Other Identifiers

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UW 09-088

Identifier Type: -

Identifier Source: org_study_id

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