This single blind crossover clinical trial aims to determine the effect of subcutaneous enoxaparin sodium injection duration on incidence and extent of bruising at injection site in patients admitted to intensive coronary care units in Heshmat hospital in Rasht. 122 samples will be selected by randomized block sampling method with inclusion criteria of patients being in the first 24 hours of hospitalization in cardiac care unit who need to remain hospitalized for at least another 48 hours; coagulation tests results within therapeutic range; written order for subcutaneous enoxaparin sodium 6000 IU in patients`record; no special treatments required (fibrinolytic therapy,...), widespread skin lesions on the right side of the abdomen or any blood and liver diseases and signing written consent form to participate in the study. Exclusion criteria includes any changes in drug order or dosage, discharge before data gathering time duration and death of a patient . Samples will be randomly allocated in two groups of A (n=56) with injection method 1 (10 seconds on the right upper abdomen) on first day and method 2 (20 seconds injection right lower abdomen) on the second day and group B (n=56) with method 2 on the first day and method 1 on second day. All injections will be performed by the researcher in the morning shifts using pre-filled enoxaparin sodium 6000 IU, prepared by Alborzdarou company, and a stopwatch to measure the time. The incidence of bruising and its extent will be evaluated by a colleague in 48 hours after each injection using a flexible ruler.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015032721547N1
Registration date:2015-06-14, 1394/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-14, 1394/03/24
Registrant information
Name
Shirin Jafroudi
Name of organization / entity
Shahid Beheshti Nursing and Midwifery College
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5058
Email address
s_jafroudi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Social determinants of Health research Center, Gilan University of medical sciences, Rasht , Iran
Expected recruitment start date
2015-05-15, 1394/02/25
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effect of subcutaneous enoxaparin sodium injection duration on incidence and extent of bruising at injection site in hospitalized patient.
Public title
Study of effect of subcutaneous enoxaparin sodium injection duration on incidence and extent of bruising at injection site in hospitalized patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients being in the first 24 hours of hospitalization in cardiac care unit who need to remain hospitalized for at least another 48 hours; coagulation tests results within therapeutic range; written order for subcutaneous 6000 IU enoxaparin sodium in patients`record; no special treatments required (fibrinolytic therapy, angioplasty,...), widespread skin lesions on the right side of the abdomen or any blood and liver diseases and signing written consent form to participate in the study.
Exclusion criteria: Any changes in drug order or dosage, discharge before data selection time duration and death of a patient .
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
ٍEastern Shahid Beheshti Boulvard, Vice Chancellor for research of Guilan University of Medical Sciences
City
Rasht
Postal code
Approval date
2015-03-17, 1393/12/26
Ethics committee reference number
2930003523
Health conditions studied
1
Description of health condition studied
ٍBruising in site of enixaparin sodium injection
ICD-10 code
T81.0
ICD-10 code description
Hemorrhage in any site resulting from a procedure
Primary outcomes
1
Description
The incidence of bruising in site of enoxaparin sodium injection
Timepoint
48 hours after intervention
Method of measurement
Recording the observed bruising in prepared form
2
Description
The extent of bruising in area of Enoxaparin sodium in Milimeter
Timepoint
48 hours after intervention
Method of measurement
Recording the bruising extent (by flexible ruler in milimeter) in prepared form
Secondary outcomes
empty
Intervention groups
1
Description
Group A: Samples(n=56) will receive pre-filled syring of enoxaparin sodium 6000 IU (prepared by Alborzdarou company), subcutaneously in two sequence days and in two methods of 1 (drug injection in 10 seconds in the right upper quadrant of abdomen) at first day and 2 (injection for 20 seconds including drug injection in 10 seconds and waiting for10 seconds more before needle withdrawal in the right lower quadrant of abdomen) at second day (24 hours apart).
Drug injection method and patient teaching content will be the same as group B, except its duration. A stopwatch will use to control the exact time.The Injected area will circled about 5 cm diameter by a waterproof pen by naming 1 for the method 1 and 2 for method 2. A trained researcher fellow without any knowledge about the groups and injection method will evaluate the injected sites for bruises incidence and extent in about 48 hours after each injection by a flexible ruler in mm.
Category
Prevention
2
Description
Group B: Samples(n=56) will receive pre-filled syring of enoxaparin sodium 6000 IU (prepared by Alborzdarou company), subcutaneously in two sequence days and in two methods of 2 (injection for 20 seconds including drug injection in 10 seconds and waiting for10 seconds more before needle withdrawal in the right lower quadrant of abdomen) at first day and method 1 (drug injection) in 10 seconds in the right upper quadrant of abdomen) at second day (24 hours apart).
Drug injection method and patient teaching content will be the same as group A, except its duration. A stopwatch will use to control the exact time.The injected area will circled about 5 cm diameter by a waterproof pen by naming 1 for the method 1 and 2 for method 2. A trained researcher fellow without any knowledge about the group and injection method will evaluate the injected sites for bruises incidence and extent 48 hours after each injection by a flexible ruler in mm.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat educational therapeutic center
Full name of responsible person
Shirin Jafroudi
Street address
Heshmat educational therapeutic center, Beheshti Boulvard.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Social determinants of health research center, Guilan university of medical sciences, Rasht, Iran
Full name of responsible person
Shirin Jafroudi
Street address
Social determinants of health research center, Beheshti nursing and midwifery college, Daneshjoo street, Western Beheshti Boulevard
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Social determinants of health research center, Guilan university of medical sciences, Rasht, Iran
Proportion provided by this source
100
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
Beheshti nursing and midwifery college, Guilan university of medical sciences
Full name of responsible person
Shirin Jafroudi
Position
Master of science in nursing, medical and surgical nursing teaching
Other areas of specialty/work
Street address
Daneshjoo street, Western Beheshti Boulvard, Beheshti nursing and midwifery college
City
Rasht
Postal code
4146939814
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
s_jafroudi@gums.ac.ir
Web page address
http://www.gums.ac.ir/sdhrc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and midwifery beheshti college, Guilan university of medical sciences
Full name of responsible person
Shirin Jafroudi
Position
Master of science in medical and surgical nursing
Other areas of specialty/work
Street address
Beheshi nursing and midwifery college, Daneshjoo street, Western beheshti Boulvard
City
Rasht
Postal code
41469 -39841
Phone
+98 13 3355 5056
Fax
+98 33550097
Email
s_jafroudi@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr
Person responsible for updating data
Contact
Name of organization / entity
Beheshti college, Guilan university of medical sciences
Full name of responsible person
Shirin Jafroudi
Position
Master science of nursing, instructor, faculty member
Other areas of specialty/work
Street address
Beheshti nursing and midwifery college, Daneshjoo street, Western Beheshti Boulvard
City
Rasht
Postal code
4146939814
Phone
+98 13 3311 0880
Fax
+98 13 3355 0097
Email
s-jafroudi@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)