Effect of prophylactic administration of fibrinogen concentrate on volume of transfused packed RBC during and after totla hip arthroplasty.

Effect of prophylactic administration of fibrinogen concentrate on volume of transfused packed RBC during and after totla hip arthroplasty in sina hospital during 2011-2012.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201012264784N2

Enrollment

Registered

2012-06-11

Start date

2011-04-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

totla hip arthroplasy. Hip-joint replacement (partial)(total)

Interventions

Intervention 1: In case group after induction of anesthesia we infuse 30mg/kg fibrinogen concentrtate IV in 15 minutes.before infusion by means of arterial catheter blood sampling perform and check

Prevention

In case group after induction of anesthesia we infuse 30mg/kg fibrinogen concentrtate IV in 15 minutes.before infusion by means of arterial catheter blood sampling perform and check it for serum lev

In control(placebo) group after induction of anesthesia we infuse normal saline in equivalent volume of fibrinogen.before infusion by means of arterial catheter blood sampling perform and check it f

Eligibility

Sex/Gender

All

Age

35 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- patients aged 35-75 years old scheduled for total hip arthroplasty 2-ASA physical status I and II 3-hemoglubin level more than 10 4-MET more than 4 5-completely fill and sign the informed consent. Exclusion criteria: 1-ASA class more than 3 2-MET<4 3-pregnancy 4-history of allergic reaction to blood products specially fibrinogen concentrate 5-history of DVT and pulmunary emboli and any embolic events. 6-recent MI and CVA during last 6 month 7-known cases of coagulopathy and thrombocytopenia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Volume of transfused packed RBC during and after totla hip arthroplasty surgery. Timepoint: any time during and after surgery that needs transfusion. Method of measurement: in mili liter.;Volume of bleeding during and after totla hip arthroplasty surgery. Timepoint: during and after surgery. Method of measurement: calculating number of gauzes and longauze and suction fluid in mililiter.;Level of hemoglobin during and after surgery. Timepoint: during and 24 hour after surgery. Method of measurement: check of hemoglobin level in perioperative period by CBC test.;Complications of transfusion. Timepoint: during and after surgery. Method of measurement: subjective if the patient is awakw and objective if the patient is anesthesized.	—

Measure

Time frame

Volume of transfused packed RBC during and after totla hip arthroplasty surgery. Timepoint: any time during and after surgery that needs transfusion. Method of measurement: in mili liter.;Volume of bleeding during and after totla hip arthroplasty surgery. Timepoint: during and after surgery. Method of measurement: calculating number of gauzes and longauze and suction fluid in mililiter.;Level of hemoglobin during and after surgery. Timepoint: during and 24 hour after surgery. Method of measurement: check of hemoglobin level in perioperative period by CBC test.;Complications of transfusion. Timepoint: during and after surgery. Method of measurement: subjective if the patient is awakw and objective if the patient is anesthesized.

—

Secondary

Measure	Time frame
Volume of transfused other blood products. Timepoint: during and after surgery. Method of measurement: as mililiter or unit of transfused product.;Thromboembolic events. Timepoint: during hospitalisation and after discharge up to 2 weeks(according to fibrinogen half life). Method of measurement: by post operative visit and examination, phone follow up until 2 weeks after discharge.;Transfusion related long term complication. Timepoint: long term after surgery. Method of measurement: subjective by patient declarement or complain or objective by take history and physical exam and labratory tests if needed.;Cardiovascular complications due to bleeding. Timepoint: during and after surgery. Method of measurement: ECG monitoring and 12 lead ECG trace record during aneshtesia ,history and physical exam after surgery.	—

Measure

Time frame

Volume of transfused other blood products. Timepoint: during and after surgery. Method of measurement: as mililiter or unit of transfused product.;Thromboembolic events. Timepoint: during hospitalisation and after discharge up to 2 weeks(according to fibrinogen half life). Method of measurement: by post operative visit and examination, phone follow up until 2 weeks after discharge.;Transfusion related long term complication. Timepoint: long term after surgery. Method of measurement: subjective by patient declarement or complain or objective by take history and physical exam and labratory tests if needed.;Cardiovascular complications due to bleeding. Timepoint: during and after surgery. Method of measurement: ECG monitoring and 12 lead ECG trace record during aneshtesia ,history and physical exam after surgery.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Reza shariat Moharari

sina hospital-tehran university of medical sciences

moharari@sina.tums.ac.ir+98 21 6634 8500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026