The Effect of Heparinization Due to LBW

Phase 4

• Conditions: Heparin; Heparin Overdose; Bleeding
• Interventions: Drug: Heparin Sodium

• Registration Number: NCT03113708
• Lead Sponsor: Adiyaman University Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-03-25
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-13
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-14
• Study Start: 2017-04-30
• Primary Completion: 2017-05-20
• Study Completion: 2017-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparinisation,actual body weight	Heparin Sodium	In 'Heparinisation,actual body weight' group , heparin sodium; will be done according to actual body weight and ACT will be recorded prior to CPB. Before coming out CPB, protamine will be done according to heparin dose. And then ACT will be recorded.
Heparinisation, lean body weight	Heparin Sodium	In 'Heparinisation, lean body weight' group heparin sodium will be done according to lean body weight and ACT will be recorded prior to CPB. Before coming out CPB, protamine will be done according to heparin dose. And then ACT will be recorded.

Primary Outcome Measures

Name	Time	Method
ACT	Through study completion, an average of 48 hours	Activated clotting time

Secondary Outcome Measures

Name	Time	Method
Bleeding	Through study completion, an average of 48 hours	Postoperative bleeding