NCT00902057

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 14, 2009

Status Verified

May 1, 2009

Enrollment Period

1.5 years

First QC Date

May 13, 2009

Last Update Submit

May 13, 2009

Conditions

Hypothermia Induced Impairment of Primary Haemostasis

Outcome Measures

Primary Outcomes (1)

  • closure time on PFA-100

    3 hours

Study Arms (4)

desmopressin 1.5

ACTIVE COMPARATOR
Drug: desmopressin

desmopressin 3

ACTIVE COMPARATOR
Drug: desmopressin

desmopressin 15

ACTIVE COMPARATOR
Drug: desmopressin

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

desmopressinDRUG

single desmopressin subcutaneous injection, 1.5mcg

desmopressin 1.5
placeboDRUG

saline subcutaneous

placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong, HKSAR, China

Location

MeSH Terms

Interventions

Deamino Arginine Vasopressin

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Central Study Contacts

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

CONTACT

(852) 28553303jkfng@hku.hk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 14, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

May 14, 2009

Record last verified: 2009-05

Locations

CN(1)