The Effect of Heparinization Due to LBW

Bleeding Clinical Trial

— LBWH  

Official title:

The Effect of Heparinization Due to LBW in Cardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03113708
• Other study ID #: LBW heparin
• 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
• 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

Related Conditions & MeSH terms

• Bleeding
• Heparin
• Heparin Overdose

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