The Effect of Heparinization Due to LBW

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Heparinization Due to LBW in Cardiac Surgery

Conditions
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Heparin, Heparin Overdose, Bleeding

Intervention / Treatment
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* Drug: Heparin Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old, first time valve surgeries which was done on-pump. Exclusion Criteria: Revision valve surgeries Patients with coagulation deficits

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Heparinisation,actual body weight<br>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. | Drug: Heparin Sodium<br>* Heparinisation 2-4 mg/kg will be done according to actual body weight or lean body weight.<br>|
| Experimental: Heparinisation, lean body weight<br>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. | Drug: Heparin Sodium<br>* Heparinisation 2-4 mg/kg will be done according to actual body weight or lean body weight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACT | Activated clotting time | Through study completion, an average of 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Postoperative bleeding | Through study completion, an average of 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heparin, heparin antagonists, cardiac surgery, active clotting time