Desmopressin for Bleeding Related to Low Body Temperature

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00902057
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 4
• Duration (Months): 24
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia Induced Impairment of Primary Haemostasis	Drug: desmopressin; Drug: desmopressin; Drug: desmopressin; Drug: placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers
• Study Start Date: Jun 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2010
• Anticipated Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: desmopressin 1.5	Drug: desmopressin; single desmopressin subcutaneous injection, 1.5mcg
Active Comparator: desmopressin 3	Drug: desmopressin; single desmopressin subcutaneous injection, 3mcg
Active Comparator: desmopressin 15	Drug: desmopressin; single desmopressin subcutaneous injection, 15mcg
Placebo Comparator: placebo	Drug: placebo; saline subcutaneous

Outcome Measures

Primary Outcome Measures

1. closure time on PFA-100 [3 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Hong Kong	Hong Kong	Hong Kong	China	HKSAR

Sponsors and Collaborators

• The University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00902057
• Other Study ID Numbers: UW 09-088
• First Posted: May 14, 2009
• Last Update Posted: May 14, 2009
• Last Verified: May 1, 2009

• Additional relevant MeSH terms: Hypothermia; Deamino Arginine Vasopressin

Study Results

No Results Posted as of May 14, 2009