The Effect of Heparinization Due to LBW

NCT ID: NCT03113708

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2017-06-20

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.

Conditions

Heparin; Heparin Overdose; Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Heparinisation,actual body weight

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.

Group Type: SHAM_COMPARATOR

Heparin Sodium

Intervention Type: DRUG

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

Heparinisation, lean body weight

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.

Group Type: EXPERIMENTAL

Heparin Sodium

Intervention Type: DRUG

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

Interventions

Heparin Sodium

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Revision valve surgeries
• Patients with coagulation deficits

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adiyaman University Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ülkü Sabuncu

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulku Sabuncu

Role: PRINCIPAL_INVESTIGATOR

Yuksek Ihtisas Hospital

Central Contacts

Ulku Sabuncu, M.D.

Role: CONTACT

sabuncuulku@gmail.com

+90 533 708 5212

Aslihan Aykut, M.D.

Role: CONTACT

asli_dncr@hotmail.com

+90 532 550 2013

Other Identifiers

LBW heparin

Identifier Type: -

Identifier Source: org_study_id