Protocol summary

Summary
Aim of study: ٍEvaluation of possible usage of Desmopressin in treatment of the patients with combined factor V and VIII deficiency. Design of procedure of the study: Owing to combined factor V and VIII deficiency is rare disorder, all anciently recognized patients with 24 cases with combined factor V and VIII deficiency, were invited to accompanying in the study and after their agreements and signing informed consent forms and also applying inclusion and exclusion criteria, 20 cases were entered to the survey. At first, the patients were admitted to hematology department in hospital and a blood sample for determination of plasma levels of factor V and VIII was obtained and one hour after infusion of vasopressin, the second blood sample was obtained to determine possible elevation of coagulation factors V and VIII. The study method including: A) Population under study: 24 cases with combined factor V and VIII deficiency . Inclusion criteria: Confirmed affection with combined factor V and VIII deficiency using an identification card of hemophilia center or coagulation laboratory sheet showing diagnosis of combined factor V and VIII deficiency; Having more than 18 years old officially; Agreement to accompanying in research and signing informed consort form after auscultation details and process of blood sampling and blood volume; No infusion of factor VIII during last 48 hours; No infusion of fresh frozen plasma or cryopercipitate during last 48 hours; Not having active bleeding in time of accompanying in research; Exclusion criteria: Affection to other similar coagulation disorders, inter alia, combined factor VIII & IX deficiency; Having less than 18 years old officially; No agreement to accompanying in research and or signing informed consort form after auscultation details and process of blood sampling and blood volume; Infusion of factor VIII during last 48 hours; Infusion of fresh frozen plasma or cyopercipitate during last 48 hours; Having active bleeding in time of accompanying in research; Sample size: 24 cases that after applying inclusion and exclusion criteria, 20 cases entered the study. Intervention: Infusion of 0.4 microgram/Kg of Desmopressin Acetat (1-deamino-8-D arginine Vasopressin) using 50 CC of normal saline 0.9% by intravenous route. Time of intervention: After sampling first blood sample. Primary outcome or studied outcomes: Possible elevation of coagulation factors V and VIII in one hour after Desmopressin. The current study was designed as before & after method. At first the levels of coagulation factors V and VIII will be measured then Desmopressin drug will be infused and after passing an hour the levels of factors V and VIII will be assayed to determine their possible effects.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015020120894N1
Registration date: 2015-04-25, 1394/02/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-04-25, 1394/02/05
Registrant information
Name
Hassan Mansouritorghabeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2830
Email address
mansouritorghabeh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
The financial expenses of current research was covered by vice chancellor for research in Mashhad University of Medical Sciences and Kedrion Company devoted needed drug free of charge to researchers.
Expected recruitment start date
2009-11-20, 1388/08/29
Expected recruitment end date
2010-09-20, 1389/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation efficacy of Desmopressin (1-deamino-8-D arginine Vasopressin) in increasing coagulation factor V and VIII in patients with combined factor V and VIII deficiency.
Public title
The evaluation efficacy of Desmopressin in improvement coagulation status of patients with combined factor V and VIII deficiency.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Confirmed affection with combined factor V and VIII deficiency using an identification card of hemophilia center or coagulation laboratory sheet showing diagnosis of combined factor V and VIII deficiency; Having more than 18 years old officially; Agreement to accompanying in research and signing informed consort form after auscultation details and process of blood sampling and blood volume; Not infusion of factor VIII during last 48 hours; Not infusion of fresh frozen plasma or cryopercipitate during last 48 hours; 6-Not having active bleeding in time of accompanying in research. Exclusion criteria: 1-Affection to other similar coagulation disorders, inter alia, combined factor VIII & IX deficiency. 2-Havingless than 18 years old officially. 3-Not agreement to accompanying in research and signing informed consort form after auscultation details and process of blood sampling and blood volume. 4-Infusion of factor VIII during last 48 hours. 5-Infusion of fresh frozen plasma during last 48 hours. 6-Having active bleeding in time of accompanying in research.
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National ethics committee in biological sciences
Street address
15th floor, Treatment and medical education, Research & Technology assistance, Main center of Ministry of Health, Treatment and Medical education, Simaie Iran Street, Between Southern Flamak and Zarafshan, Ghods city (West)
City
Tehran
Postal code
1445382774
Approval date
2009-10-12, 1388/07/20
Ethics committee reference number
4پ/88ک-1

2

Ethics committee
Name of ethics committee
Regional ethics committee in Mashhad University of Medical Sciences
Street address
Ethics committee office, 2nd floor, Ghoreishi Building, Daneshgah Street
City
Mashhad
Postal code
91766-99199
Approval date
2007-12-16, 1386/09/25
Ethics committee reference number
86029

Health conditions studied

1

Description of health condition studied
Combined factor V and VIII deficiency
ICD-10 code
D68.2
ICD-10 code description
Hereditary deficiency of other clotting factors

Primary outcomes

1

Description
Plasma level of coagulation factor V
Timepoint
One hour after termination of DDAVP injection
Method of measurement
According to standard one-stage APTT method

2

Description
Plasma level of coagulation factor VIII
Timepoint
One hour after termination of DDAVP injection
Method of measurement
According to standard one-stage APTT method

Secondary outcomes

1

Description
ّFlushing
Timepoint
One hour after injection of Desmopressin
Method of measurement
Appearance of flushing in face and felling of warmness by the patients

Intervention groups

1

Description
Injection of 0.4 micrograms per kilogram of body weight (mcg/kg) of Desmopressin by 50 ml of 0.9% sodium chloride via intra-venous route over period of 20 minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hematology ward, Ghaem hospital
Full name of responsible person
Dr. Abbas Shirdel
Street address
Hematology ward, Ghaem hospital
City
Mashhad

2

Recruitment center
Name of recruitment center
Allergy/Immunology Research Center
Full name of responsible person
Hassan Mansouritorghabeh
Street address
Allergy ward, 3rd floor, Ghaem Hospital
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Saieed Eslami
Street address
Research Managment, Ghoreieshi Building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Kedrion
Full name of responsible person
Lorenzo Morini
Street address
Castelvecchio Pascoli Loc, Ai Conti 55051
City
Barga
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kedrion
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Mansouritorghabeh
Position
MSc in hematology and PhD student
Other areas of specialty/work
Street address
Allergy ward, 3th floor, Ghaem hospital
City
Mashhad
Postal code
91766-99199
Phone
+98 51 3801 2830
Fax
+98 51 3842 2544
Email
mansouritorghabeh@mums.ac.ir
Web page address
www.mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Mansouritorghabeh
Position
MSc in hematology and PhD student
Other areas of specialty/work
Street address
Allergy ward, 3rd floor, Ghaem Hospital
City
Mashhad
Postal code
91766-99199
Phone
+98 51 3801 2830
Fax
+98 51 3842 2544
Email
mansouritorghabeh@mums.ac.ir
Web page address
www.mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Mansouritorghabeh
Position
MSc in hematology and PhD student
Other areas of specialty/work
Street address
Allergy ward, 3rd floor, Ghaem hospital
City
Mashhad
Postal code
91766-99199
Phone
+98 51 3801 2830
Fax
+98 51 3842 2544
Email
mansouritorghabeh@mums.ac.ir
Web page address
www.mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...