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Evaluation of the effect of local cold pack application on bleeding and hematoma after Angioplasty

Evaluation of the effect of local cold pack application on vascular access site bleeding and hematoma after sheath removal in patients undergoing Angioplasty & Stenting

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014122920472N1
Enrollment
66
Registered
2015-02-11
Start date
2015-01-05
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioplasty and Senting. Presence of coronary artery prosthesis Status following coronary angioplasty NOS

Interventions

Intervention 1: 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 rev
Prevention
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 res
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

Sponsors

Shahid Sadoughi University of Medical Sciences and Health Services
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.;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

MeasureTime frame
Blood Pressure. Timepoint: During the study. Method of measurement: Monitoring.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamane sadat Javadi

Shahid Sadoughi University of Medical Sciences and Health Services

samanejavadi@ssu.ac.ir javadi.samane@yahoo.com javadi2samane@gmail.com+98 35 3824 1755

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026