Evaluation of the effect of local cold pack application on vascular access site bleeding and hematoma after sheath removal in patients undergoing Angioplasty & Stenting
The aim of the study is determining "the effect of cold-pack therapy on bleeding and hematoma after sheath removal in patients undergoing percutaneous coronary interventions". This is an interventional study with parallel approach by repeated measures, with a control group and before and after design. The population of this study consist patients' undergoing angioplasty and stenting procedure. Inclusion Criteria: non-emergency angioplasty or stenting by femoral artery approach with a sheath size of 6 or 7 French; age between 18-80 years; the absence of active bleeding disorders; INR< 2; Not receiving thrombolytic drugs and only one try for entrancing sheaths in femoral artery. Exclusion Criteria: integrilin administration during the procedure; systolic and diastolic blood pressure over 190 and 110 respectively; complications during catheterization; need for cardio-pulmonary resuscitation (CPR); chest pain with ECG changes; hemodynamic impairment during the study; no sense of arterial pulses lower than sheath access point; presence of hematoma at the beginning of study in puncture site; foreign patients who are unable to cooperate. After transferring the patient to the CCU, ACT will be assess by the researcher and if it is less than 180 seconds, the sheath will be removed and immediately hand pressure will be applied equally by the same researcher assistance to both groups at the puncture site for 20 minutes. The next step in the intervention group cold-pack will be placed for 30 minutes in sheath removing site and patients in control group will receive routine protocol (local pressure with sand bags during 4 hours and 6 hours complete bed rest). Bleeding and hematoma will be examined consistently until the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122920472N1
Registration date:2015-02-11, 1393/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-11, 1393/11/22
Registrant information
Name
Samane sadat Javadi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 3724 0173
Email address
samanejavadi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences and Health Services
Expected recruitment start date
2015-01-05, 1393/10/15
Expected recruitment end date
2015-07-06, 1394/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of local cold pack application on vascular access site bleeding and hematoma after sheath removal in patients undergoing Angioplasty & Stenting
Public title
Evaluation of the effect of local cold pack application on bleeding and hematoma after Angioplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: non-emergency angioplasty or stenting by femoral artery approach with a sheath size of 6 or 7 French; age between 18-80 years; the absence of active bleeding disorders; INR< 2; Not receiving thrombolytic drugs and only one try for entrancing sheaths in femoral artery. Exclusion Criteria: integrilin administration during the procedure; systolic and diastolic blood pressure over 190 and 110 respectively; complications during catheterization; need for cardio-pulmonary resuscitation (CPR); chest pain with ECG changes; hemodynamic impairment during the study; no sense of arterial pulses lower than sheath access point; presence of hematoma at the beginning of study in puncture site; foreign patients who are unable to cooperate
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences and Health Services
Street address
Yazd, Ba Honar square, Shahid Sadoughi University of Medical Sciences and Health Services
City
Yazd
Postal code
Approval date
2014-11-08, 1393/08/17
Ethics committee reference number
163518 /17/1/پ
Health conditions studied
1
Description of health condition studied
Angioplasty and Senting
ICD-10 code
Z95.5
ICD-10 code description
Presence of coronary artery prosthesis Status following coronary angioplasty NOS
Primary outcomes
1
Description
Hematoma
Timepoint
Immediately after Hemostasis (before using ice packs), 0.5, 1, 2, 4 and 6 hours after the onset of ice packs and in the morning after Angioplasty and Stenting
Method of measurement
Rule-based cm2
2
Description
Bleeding
Timepoint
Immediately after Hemostasis (before using ice packs), 0.5, 1, 2, 4 and 6 hours after the onset of ice packs and in the morning after angioplasty and stenting
Method of measurement
Scale with a sensitivity of 0.01 grams
Secondary outcomes
1
Description
Blood Pressure
Timepoint
During the study
Method of measurement
Monitoring
Intervention groups
1
Description
For reduce the effect of the intervention on the results, the selected samples are Angioplasty and stenting by a specialist, then the patient is transferred to the CCU. ACT will be reviewed by the researcher and if less than 180 seconds, the sheath is removed and immediately hand pressure applied equally by the same researcher assistance to both groups at the exit sheath for 20 minutes. The next step will be placed in the intervention group ice bag for 30 minutes on the sheath exit and bleeding and hematoma measure and record during and immediately after hemostasis (before using ice packs), 0.5, 1, 2, 4 and 6 hours after the onset of use ice packs, also the morning after angioplasty and stenting. The patient gets out of bed 6 hours after sheath removal to help the researcher. The dressing can be done at the patient's groin. Over time, the use of ice packs, bleeding is observed in the site of sheath removal .
Category
Prevention
2
Description
In the control group, sand bags can be placed on the sheet removal site for 4 hours and the patient out of bed after 6 hours. In the control group, bleeding and hematoma measure and record during and immediately after hemostasis (before using sand bag), 0.5, 1, 2, 4 and 6 hours after the onset of use sand bag , also the morning after angioplasty and stenting. The patient gets out of bed 6 hours after sheath removal to help the researcher. The dressing can be done at the patient's groin. Over time, the use of sand bags, bleeding is observed in the site of sheath removal .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Afshar Hospital
Full name of responsible person
Samane sadat Javadi
Street address
Afshar Hospital, Jomhori blvd,Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Amir Hooshang Mehrparvar
Street address
Nursing and Midwiery school, Bu ali street, Safaee, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences and Health Services
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
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Samane sadat Javadi
Position
BS in Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery school, Bu ali avenue, Safaee, Yazd