Desmopressin for Bleeding Related to Low Body Temperature

Hypothermia Induced Impairment of Primary Haemostasis Clinical Trial

Official title:

Effect of Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00902057
• Other study ID #: UW 09-088
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 13, 2009
• Last updated: May 13, 2009
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: May 2009
• Source: The University of Hong Kong
• Contact: Kwok F.J. Ng, MBChB, MD, MBA, FANZCA, FHKAM
• Phone: (852) 28553303
• Email: jkfng[@]hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia Induced Impairment of Primary Haemostasis

Intervention

Drug:
• desmopressin
single desmopressin subcutaneous injection, 1.5mcg
• desmopressin
single desmopressin subcutaneous injection, 3mcg
• desmopressin
single desmopressin subcutaneous injection, 15mcg
• placebo
saline subcutaneous

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	closure time on PFA-100		3 hours	No