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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03113708
Other study ID # LBW heparin
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received March 25, 2017
Last updated April 13, 2017
Start date April 30, 2017
Est. completion date June 20, 2017

Study information

Verified date April 2017
Source Adiyaman University Research Hospital
Contact Ulku Sabuncu, M.D.
Phone +90 533 708 5212
Email sabuncuulku@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

High dose heparin regimens are required in cardiac surgery under cardiopulmonary bypass (CPB) and this may increase postoperative bleeding. The aim of this study is to evaluate the effect of heparin dose calculated according to lean body weight on intraoperative and postoperative bleeding.


Description:

Patients with preoperative demographic data such as age, gender, body weight, height, and additional disease, medications, previous surgery, preoperative Htc / Hb values were recorded in the operation room without medical premedication. Standard anesthesia induction was performed after arterial cannulation and peripheral venous route. Patients were randomly divided into two groups: 400 IU heparin / kg (Group I) and 400 IU heparin / kg (Group II) according to actual body weight and lean body weight respectively before CPB. Before and after heparin administration, CPB entry and ACT (Activated Clotting Time) values were counted every 30 minutes, after CPB exit and protamine. In both groups, supplemental heparin was administered when there was a failure to reach the pre-CPB target ACT value of 400 sec. Hemodynamic data and transfusion requirements were recorded during the operation. Patient's intraoperative CPB and crossover times, postoperative drainage volume and blood transfusion requirement were recorded.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 20, 2017
Est. primary completion date May 20, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 18-65 years old, first time valve surgeries which was done on-pump.

Exclusion Criteria:

- Revision valve surgeries

- Patients with coagulation deficits

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Heparin Sodium
Heparinisation 2-4 mg/kg will be done according to actual body weight or lean body weight.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Adiyaman University Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary ACT Activated clotting time Through study completion, an average of 48 hours
Secondary Bleeding Postoperative bleeding Through study completion, an average of 48 hours
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