A Randomised Controlled Trial To See The Effect Of Post- Operative Systemic Anticoagulation In Patients Undergoing Post Traumatic Medium Sized Vessel Repair
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Aiims
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- To assess the effect of post operative systemic anticoagulation in terms of patency of medium size peripheral arterial repair in a vascular trauma
研究概览
简要总结
Those Patients Who Will be Operated for definitive arterial repair will be included in the study considering in lusion and exclusion criteria, informed consent will be obtained, patient will be randomised in two groups, both groups will receive intra-op bolus heparin 80IU/KG Body weight. In post op period, group A will receive maintenance i.v heparin 18 IU/KG For 3 days while group B will not receive any systemic Anticoagulation in post op period.colour Doppler will be scheduled at post op day 2 and 5 OR Earlier in case of absent peripheral pulse in operated limb.
Outcome measures: patency of the repaired artery as measured by Doppler Study at an interval of 48 hours and 5th post op day or at the time of discharge whichever is later.
Signs of bleeding requiring re-exploration or blood products transfusion.
Re-exploration will be decided after consultation with treating faculty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 3.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with medium size vessel injury(4-8mm) includes Axillary artery, Brachial Artery,Femoral artery and Popliteal artery.
排除标准
- •Patients with head injuries.
- •Pregnant Females.
- •Patients already on Anticoagulation.
- •Venous/Prosthetic graft repair.
- •Contraindication of Anticoagulation due to associated injuries/Co-morbidities including CAD, Ischaemic heart disease, Stroke, Coagulopathies etc.
结局指标
主要结局
To assess the effect of post operative systemic anticoagulation in terms of patency of medium size peripheral arterial repair in a vascular trauma
时间窗: To assess the effect of post operative systemic anticoagulation in terms of patency of medium size peripheral arterial repair in a vascular trauma on post operative day 02 and just bedore discharge or on day 05 whichever is later
次要结局
- To assess complications like(Post operative bleeding)